WO2023164711A2

WO2023164711A2 - Apparatus and method for cleaning materials for medical devices

Info

Publication number: WO2023164711A2
Application number: PCT/US2023/063378
Authority: WO
Inventors: Greg LANGLEY; Dean Carpenter; Nick LUCARELLI; David Burnett; Amir Genosar; Daniel Rose
Original assignee: Aktivax, Inc.
Priority date: 2022-02-28
Filing date: 2023-02-27
Publication date: 2023-08-31
Also published as: WO2023164711A3

Abstract

A method and apparatus for cleaning, sterilization, and depyrogenation of materials comprising a nozzle or an array thereof, a material to be cleaned, a reservoir containing high pressure fluid, a flow regulator system, an apparatus such as a reel-to-reel machine or a conveyor to move the material in relation to the nozzle or array. The flow regulator establishes a controlled release of fluid from a reservoir through the nozzle, which nozzle is configured to reduce the pressure of said fluid and form a stream of frozen projectiles. The stream of frozen projectiles removes particulate matter from the surface of the material. The apparatus may be configured for cleaning, sterilization, and/or depyrogenation of film or web materials for use in medical device applications, and especially for materials applications for containers or other elements of such devices wherein the materials will be in contact with sterile beneficial agents for parenteral administration.

Description

Apparatus and Method for Cleaning Materials for Medical Devices

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims priority to U.S. Provisional Application Serial No. 63/314,912 filed February 28, 2022 and entitled “Method and apparatus forcer cleaning materials for medical devices,” to U.S. Provisional Application Serial No. 63/424,112 filed on November 9, 2022 and entitled “Web Treatment Apparatus,” and to U.S. Provisional Application Serial No. 63/480,928 filed on January 20, 2023 and entitled “Web Treatment Apparatus,” all of which are incorporated by reference herein in their entirety. In the event that definitions or descriptive terms used in any patents or patent applications incorporated by reference conflict with definitions or descriptive terms used in the present application, the use in the present application will control.

FIELD OF THE INVENTION

[0002] The present disclosure relates to the field of film treatment processes such as cleaning, sterilization, and depyrogenation, including processes applying treatment to a flexible polymer web material.

BACKGROUND TO THE INVENTION

[0003] Small quantities of contamination may be detrimental to the safety, sterility, and operation of medical devices and may be particularly detrimental to the components of those devices which come into contact with sterile injectable agents. Conventional methods of treating polymer surfaces by cleaning, depyrogenation, or sterilization, such as wet cleaning or abrasive granule sand-blasting type systems, may themselves introduce unwanted foreign matter, such as detergents or other chemical additives or unwanted granules, into the materials being treated. Wet cleaning methods may also raise concerns around water conservation, with much effort across industries focused on finding alternatives that minimize water use in manufacturing processes.

[0004] Other techniques like ultraviolet light or ozonation may be used to decompose contaminating hydrocarbons or to sterilize web materials and surfaces, but these techniques may be less efficacious in removing inorganic contaminants or particles. Other irradiating techniques, such as gamma sterilization, may limit throughputs on product streams due to the time involved in their production. Many polymer families, such as polystyrenes and polypropylenes, can be incompatible with gamma sterilization due to rapid degradation upon y-ray irradiation. Partial degradation of a much wider array of polymers can result in the production of a range of radical species, which may attack pharmaceutical compounds and degrade their stability when stored in “/-irradiated polymer packaging.

SUMMARY OF THE INVENTION

[0005] The present disclosure relates to an apparatus for treating material, such as a sheet of material that is flexible and substantially planar. The apparatus for treating material may extend from an upstream region to a downstream region, also referred to as a first region and a second region, and may include multiple subsystems. Treating a material may include a plurality of subsystems applying a plurality of treatments to a material in sequence or simultaneously. The apparatus for treating material may include a material mover configured to advance a material from the upstream region to the downstream region. Either or both regions may include a reel, sometimes referred to as a roller. In this way, the apparatus for treating material may include a material mover comprising a reel-to- reel material transport system.

[0006] A sheet may comprise a source material for the manufacture of formed pieces of material. The arrangement of the sheet may be planar, and the sheet may be kept substantially taught along a material pathway extending from a first or upstream region to a second or downstream region. This arrangement may reveal planar surfaces on either side of the sheet of material, which may expose both surfaces to treatment by a treatment system, including a substance expulsion system, or by other component systems of the overall apparatus for treating a material.

[0007] The first (e.g., upstream) region of the material treatment apparatus may be maintained in a first state of cleanliness, and the second (e.g., downstream) region of the material treatment apparatus may be maintained at a second state of cleanliness greater than the first state of cleanliness. The relative state of cleanliness may be defined by a lower particle count or pyrogen count in the second, or may be defined by a lower degree of biological risk, and may be defined by such counts or risks regardless of any applicable regulatory or industrial standards.

[0008] In some implementations, the downstream region may meet a more rigorous particle count standard according to ISO 14644 or any equivalent or succeeding particle count standard. The downstream region may meet a more rigorous biocontamination control standard according to ISO 14698 or an equivalent or succeeding biocontamination control standard. In embodiments of the invention where the treatment involves depyrogenation of the material, the downstream region may be maintained at a lower pyrogen count than the first region. Treatment may involve sterilization of the material, and the downstream region may be maintained in aseptic conditions, such as cleanroom conditions. These arrangements may be combinable with each other, and may be one and the same arrangement in some embodiments.

[0009] In some implementations, the first region may be a non-classified environment and may be maintained in a non-classified state of cleanliness, such as a state of regular sweeping, dusting, mopping, or another routine janitorial service, and the second region may satisfy some or all of the requirements of ISO Class 4, 5, 6, or 7 cleanroom conditions.

[0010] In some implementations, the state of cleanliness of the first region may satisfy some or all of the requirements of ISO Class 8, and the state of cleanliness of the second region may satisfy some or all of the requirements of ISO Class 4, 5, 6, or 7.

[0011] In some implementations, the state of cleanliness of the first region may satisfy some or all of the requirements of ISO Class 7, and the state of cleanliness of the second region may satisfy some or all of the requirements of ISO Class 4, 5, or 6.

[0012] In some implementations, the state of cleanliness of the first region may satisfy some or all of the requirements of ISO Class 6, and the state of cleanliness of the second region may satisfy some or all of the requirements of ISO Class 4 or 5.

[0013] In some implementations, the state of cleanliness of the first region may satisfy some or all of the requirements of ISO Class 5, and the state of cleanliness of the second region may satisfy some or all of the requirements of ISO Class 4.

[0014] The material cleaning system may comprise a frozen gas projectile cleaning system. The frozen gas projectile cleaning system may be disposed along a pathway of the material between the upstream region and the downstream region.

[0015] In one arrangement, a fluid flow region extends along a pathway of the material from a downstream end to an upstream end and may surround the material pathway. A flow of fluid, such as a gaseous flow, may be directed through a conduit and across the material in the upstream direction. In this way, the fluid flow can be configured to maintain a relatively cleaner state of cleanliness on the downstream end relative to the upstream end. The fluid flow may include a gaseous flow of air, nitrogen, carbon dioxide, argon, or any equivalent composition. Such fluid flow may be capable of entraining removed particles and transporting them to and/or past the upstream end of the fluid flow region. A gaseous flow may be produced by an elevated pressure in the downstream end or by an apparatus such as an air knife or its equivalents. [0016] A fluid flow region may include a fluid flow, which in some examples may include a laminar flow, across the downstream region and/or across the material. Laminar flow may be directed in any direction, and the direction of laminar flow may depend on the configuration of the material transport system, any of the subsystems of the material treatment apparatus, on engineering needs, on manufacturing convenience to optimize or maximize material throughput, on adherence to particle count or biocontamination control standards as described, or on other factors. Fluid flow may be directed from the downstream region to the upstream region, also referred to as the second region and the first region, respectively. The fluid flow may be directed vertically downward in either region, the arrangement being such that the fluid flow works with gravity to transport particles removed by a treatment away from the material. In some variations, the downstream region may be contained in a chamber such as an isolator, a glovebox, a cleanroom, or another enclosure, and such an enclosure may facilitate maintaining the downstream region at the more stringent second state of cleanliness.

[0017] The material may comprise a flexible and substantially planar polymer material, also referred to as a web, and may be unwound from a first reel in the first region prior to treatment and rewound on a second reel in the second region after treatment. Such a material may be packaged at the downstream region such that its cleanliness after treatment is not compromised when removed from the downstream region. The material may include a formed section or sections, such as thermoformed shapes extending out of the plane of the material.

[0018] In one arrangement, the material treatment apparatus further comprises an inspection system that may inspect for a controlled characteristic. Such a controlled characteristic may be any of material cleanliness, visible particle count, visible pyrogen count, damage, physical parameters such as temperature or light transmission, treatment inconsistencies, and other controlled characteristics of the material.

[0019] The inspection system may further comprise a marking system arranged so as to mark the sections of the material that the inspection system determines to be unsuitable according to a measured value of a controlled characteristic. Inspection for detection of defects may take the form of an electronic vision system comprising any of a camera, a laser diode and detector, an automated optical inspection, an automated UV/IR inspection, an automated X-ray inspection, or any equivalent. Inspection may examine transmitted or reflected electromagnetic radiation to detect defective areas. Defects may result from a treatment of the material. The marking system may comprise a hot or cold embossing system, a gravuring system, an etching system, a sterile lithography process, or an equivalent system and may mark a section of the material according to system input regarding the controlled characteristic.

[0020] The demarcation may be detectable by an inspection system included in a subsequent process system, such as a thermoforming system, a heat welding system, a lamination system, or a form-fill- seal system. Inspection may be conducted by a process operator or technician, or such inspection system may comprise an electronic vision system comprising any of a camera, a laser diode and detector, automated optical inspection, automated UV/IR inspection, automated X-ray inspection. Such inspection may be configured to examine transmitted or reflected electromagnetic radiation to detect marked areas.

[0021] The material treatment may be configured to correct defects in the material (e.g., defects demarcated by the inspection system). For example, the material treatment may include controlled heating of the surface of the material to reduce or eliminate non-particulate physical defects from the surface, such as divots, tears, or cracks. The surface heating process may involve infrared radiation, bringing the material surface into contact with a heated gas, passing the material across a hot roller, or ironing. Appropriately configured, such surface heat treatment may repair any surface roughness resulting from the application of the frozen gas particle blasting treatment applied to the material.

[0022] Other material treatments for preparing the material for manufacturing may comprise any of corona treatment, UV treatment, vibration, particle cleaning using sticky rollers, washing with surfactant, washing with sterilized water, exposure to ionized air, electron beam radiation, or x-ray treatment. The system may further comprise an arrangement for replacing the upstream reel and/or the downstream reel without compromising the treatment of the last section of the material on a reel.

[0023] The mechanical action of frozen projectiles of argon, nitrogen, water, carbon dioxide, a mixture thereof, or their equivalent fluids may be used to clean the surface of a polymer film, a layered composite film, a thermoformed or thermoset plastic, ceramic, glass, metallic foil or their equivalents for use in medical devices. In device applications, these materials may come into contact with sterile injectable medical agents. Such medical agents may be singly comprised or may be stored as multiple components and mixed or reconstituted before or in the course of the operation of a medical device. [0024] A treatment system may include jets comprising particulates of argon, nitrogen, water, carbon dioxide, or any mixture thereof or their equivalents. The water may be USP-grade water-for- inj ection in some configurations. The particulate j ets may be used to snowblast the surface of a material. A pressurized fluid mixture may be expanded in a nozzle to reduce its pressure and precipitate solid or liquid particulates from some fraction of the fluid flow. The pressure may be reduced to near or below atmospheric pressure. The precipitates may strike the surface of a material and remove contaminants that may be adhered to the surface.

[0025] A particulate jet treatment system may include at least one nozzle, as described. Nozzles may be configured singly or as an array and may be disposed on either side of a film, and a nozzle or nozzle array may be configured parallel across a transverse width of a material or in sequence along a length of a material. The nozzle or nozzle array may be fed by a fluid source and may be configured such that the fluid expands and reduces in pressure at the nozzle outlet, the expansion process resulting in Joule-Thomson cooling and in the formation of condensed solid or liquid phase particulates. The particulates may then comprise a jet direct towards the surface of a material disposed relative to the nozzle opening. The mechanical action of the particulates may treat the surface of the material, and the treatment may include cleaning, sterilization, and/or depyrogenation of the material. Such a treatment may be applied across an entire transverse width of the material. The treatment may be performed in an environment maintained at a state of cleanliness, such as a clean room, process tent, or a chemical hood, and treatment may be performed under laminar flow from a HEPA filtration system. The state of cleanliness may meet or exceed ISO 7 requirements for a sterile production environment.

[0026] In alternate embodiments, a nozzle or nozzle array may be configured relative to the geometry of a material which may include a film, web, formed section, device component element, whole device component, or whole device. The configuration may be such that the mechanical action of the particulate jet is brought to bear on the surface or surfaces of the device. Configurations may include manual aiming by a technician or a robotic arm, a fixed configuration arranged in relation to a material handling conveyor, a nozzle array configured in relation to a material batch set, or may otherwise conform to the geometry of a material to be treated. Treatment may include cleaning, sterilization, and/or depyrogenation. The treatment system may additionally or alternatively be configured to polish or buff a surface of a material using the mechanical action of the particulates. In such configurations, the particulate stream may act to remove a portion of the surface of a material, including a portion of a surface of a film, web, device component element, whole device component, or whole device to create a new surface with desired characteristics.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1A illustrates an implementation of an apparatus for treating material.

Figure IB illustrates another implementation of an apparatus for treating material.

Figure 2 illustrates a subsystem comprising a contact roller set.

Figure 3 illustrates a subsystem comprising a vacuum vibrational cleaner.

Figure 4A illustrates a subsystem comprising a frozen particle treatment system.

Figure 4B illustrates the frozen particle treatment system from a perspective view.

Figure 5 illustrates a subsystem comprising a heat treatment system.

Figure 6 illustrates a subsystem comprising a visual inspection system, a control device configured to receive an input from the visual inspection system and generate an output, and a surface treatment system configured to selectively apply a surface treatment to the material in response to the output.

Figure 7 illustrates a subsystem comprising a material positioning system.

Figure 8 illustrates an exemplary method of treating a material according to the disclosed teachings.

DETAILED DESCRIPTION OF THE INVENTION

[0027] Figure 1A and Figure IB each illustrate alternative embodiments of a material treatment apparatus 1000 and 1010 respectively.

[0028] As illustrated in Figure 1A, a material treatment apparatus 1000 may extend from a first region 1900 (e.g., an upstream region) to a second region 1910 (e.g., a downstream region). The first region 1900 may be disposed at an upstream end of the pathway followed by a material 101, and the second region 1910 may be disposed at the downstream end of a pathway followed by the material 101. The material treatment apparatus 1000 may include subsystems applying one or more treatments to the material 101 in sequence, in parallel, contemporaneously, or simultaneously. The material treatment apparatus 1000 may comprise a material transport system or material mover configured to transit a material 101 from the first region 1900 to the second region 1910. In an implementation, the material transport system or material mover is configured to transit the material 101 from the first region 1900 to the second region 1910 via a fluid flow region 150. In implementations, the fluid flow region is maintained at substantially a same state of cleanliness as the second region 1910. The first region 1900 may include a first reel 110 (e.g., an upstream reel to provide and/or unspool the material 101 to be treated) positioned within the first region 1900, and the second region 1910 may include a second reel 100 (e.g., a downstream reel to receive and/or spool the material 101 after treatment) positioned within the second region 1910, and both reels may be included in the material transport system or material mover. In this way, the material transport system may be configured as a reel-to-reel transport system able to transport a sheet of material that is flexible and substantially planar. In an implementation, the sheet of material may include a polymer layer. The material transport system may be configured to accommodate a material comprising a formed section in some embodiments.

[0029] The first region 1900 of the material treatment apparatus 1000 in Fig. 1A may be maintained in a first state of cleanliness, and the second region 1910 of the material treatment apparatus may be maintained at a second state of cleanliness greater than the first state of cleanliness. The greater state of cleanliness may be defined by a lower particle count or pyrogen count in the second region 1910 or may be defined by a lower degree of biological risk in the second region 1910. The second region 1910 may meet a more rigorous particle count standard according to ISO 14644 or any equivalent or succeeding particle count standard. Additionally or alternatively, the second region 1910 may meet a more rigorous biocontamination control standard according to ISO 14698 or an equivalent or succeeding biocontamination control standard. In an implementation, the second region is aseptic, and the first region is not aseptic.

[0030] A treatment system 140 may be disposed along the pathway of the material 101 between the first region 1900 and the second region 1910, within the first region 1900, within the second region 1910, or within a fluid flow region 150. The treatment system 140 may include one or more fluid feed lines, one or more nozzles, and one or more particulate jets comprising particulates of a volatile treatment substance in solid or liquid particulate form (e.g., solid or liquid carbon dioxide particles). The treatment substance may be communicated through a fluid conveyance system (e.g., through tubing) to the nozzles of the treatment system from a substance source, such as a reservoir, canister, pressure vessel, or other vessel configured to hold a substance. The treatment system 140 may remove particles from a portion of the material 101. In an implementation, the treatment substance is provided to the nozzles at a first pressure that is higher than a second pressure of an environment of the fluid flow region 150 or second region 1910 in which the portion of the material receives the treatment substance from the expulsion in jets by the nozzles. In an implementation, the difference between the first pressure and the second pressure at least partially transitions the treatment substance from a fluid state to a solid state. In an implementation, the second pressure is at or below atmospheric pressure and/or is at the slightly elevated pressure of the positive pressure environment. The portion of the material 101 downstream from the treatment system 140 may be in a treated condition based on a treatment by the treatment system 140.

[0031] The material treatment apparatus 1000 of Fig. 1A may include a fluid flow region 150 extending along the pathway of the material from a downstream end to an upstream and may surround the material pathway. A flow of fluid including a gaseous flow may be directed through a conduit 151 and across the material in the upstream direction. In an implementation, any fluid communication between the second region 1910 and the first region 1900 is via the conduit l51. The fluid flow region 150 may include one or more airflow systems 152, which may be configured as air knives. The flow of fluid through the fluid flow region 150 may maintain a relatively cleaner state of cleanliness in the downstream end of the fluid flow region 150 relative to the upstream end. The flow of fluid may include a gaseous flow of air, nitrogen, carbon dioxide, argon, or any equivalent composition. Such flow of fluid may entrain removed particles such as those removed by a treatment system 140. and transport them to and/or past the upstream end of the fluid flow region. A gaseous flow may be produced by an elevated pressure in the downstream end of the fluid flow region or by an apparatus such as an air knife or its equivalents.

[0032] The flow of fluid through the fluid flow region 150 may produce or be included in the flow of fluid 195 into a removed particle treater 190. The flow of fluid 195 may convey removed particles through the removed particle treater 190 to a removed particle treatment 196, which may include treatment by one or more of ultraviolet radiation, gamma irradiation, other EMR, a heating, an incineration, or a sterilizing fluid application. The inclusion of a removed particle treater 190 in a material treatment apparatus 1000 may serve to ensure removed particles satisfy a predefined condition, such as a condition of being chemically decomposed, denatured, or rendered biologically inert.

[0033] The second region 1910 may include a laminar flow 165, which may be directed at least partially vertically downward (e.g., and upstream) with respect to gravity. In this implementation, the material 101 (e.g., a sheet of material) may be oriented at least partially vertically (e.g., by intermediate rollers) to allow for the particulates to fall. In an implementation, the second region includes a flow of filtered fluid that was filtered through a high-efficiency particulate air (HEP A) filtration system. A fluid flow region 150 may optionally include a fluid flow comprising a laminar flow 165 across the second region 1910 and/or across the material pathway. In alternative arrangements, the laminar flow 165 may be directed in any direction, and may generally be configured to ensure a positive pressure environment in the second region 1910. A flow of fluid may be directed from the second region 1910 to the first region 1900. A laminar flow 165 may be in either region. In implementations, the fluid flow works with gravity to transport removed particles removed by a treatment away from the material. In some variations, the second region 1910 may comprise an isolator, a glovebox, a cleanroom (e.g., a cleanroom isolator), a Restricted Access Barrier System (RABS), or another enclosure, and such an enclosure may facilitate maintaining the second region 1910 in the cleaner second state of cleanliness.

[0034] Fig. 1 includes a demarcation line 1911, indicating an arrangement of a boundary between a first region 1900 and a second region 1910. One end of the demarcation line 1911 extending vertically downward in the diagram indicates an arrangement where a flow of fluid 195 flowing into a removed particle treater 190 is disposed in the second region. In this arrangement, the removed particle treater 190 may convey a flow of fluid 195 across a boundary into the first region to be treated by a removed particle treatment 196.

[0035] Another end of the demarcation line 1911 extending horizontally towards the downstream end of the material pathway indicates an arrangement where the flow of fluid 195 and the removed particle treater 190 are disposed entirely external to the second region 1910. This may be advantageous for embodiments where the entirety of the second region 1910 is maintained in a relatively cleaner state of cleanliness, as this arrangement may prevent or restrict any removed particles removed by a treatment system from entering the second region 1910.

[0036] The material treatment apparatus 1000 may include a particulate removal system 120, which may comprise a primary particulate removal roller configured to contact the material 101 to remove particulates from the portion of the material, and a secondary particulate removal roller configured to contact the primary particulate removal roller to remove particulates from the primary particulate removal roller. The primary particulate removal roller may be a rubberized roller configured to leave substantially no residue when contacting the material 101, and the secondary particulate removal roller may be a sticky roller with a sticky material on a surface of the secondary particulate removal roller configured to roll over the primary particulate removal roller. [0037] The material treatment apparatus 1000 of Fig. 1A may optionally include one or more airflow systems 125 disposed at locations along the material pathway. The one or more airflow systems 125 may include air knives or other airflow-generating devices.

[0038] The material treatment apparatus 1000 may include a vibrational cleaning system 130, which may include a static charge neutralizing ion flow, one or more out-flow lines 135 and 137, and/or one or more air in-flow line 136 configured to vibrate the material 101 such that surface particles including hydrocarbon compounds, pathogens, and/or pyrogens may be de-adhered from the surface of the material 101. Put another way, the vibrational cleaning system 130 sonicates the material 101 in air to shatter weakly adhered surface features such that they may be removed by the one or more out-flow lines 135 and 137.

[0039] The material 101 may comprise a flexible and substantially planar polymer web, and may be unwound from a first reel 110 in the first region 1900 prior to applying a treatment and rewound on a second reel 100 in the second region 1910 after applying a treatment. Such a material 101 may be packaged at the second region 1910 such that its treated condition is maintained in the second region 1910. In some variations of the material treatment apparatus 1000, the material 101 may include a formed section or sections, such as thermoformed shapes extending out of the plane of the material.

[0040] The material treatment apparatus may optionally include an inspection system 170 which may inspect the material 101 for a measured value indicating information about a controlled characteristic of the portion of the material 101. The inspection system 170 may determine whether the material 101 satisfies a quality condition after treatment based on the measured value (e.g., a predefined threshold value or a predefiend range of values). Such a measured value may be any of material cleanliness, visible/detectable particle count, visible/detectable pyrogen count, visible/detectable damage, physical parameters such as temperature or light transmission, detectable treatment inconsistencies, or other measurable value(s) which may indicate information about the material 101. Inspection may take the form of an electronic vision system detecting electromagnetic radiation (EMR), including, for example, an EMR emitter configured to emit EMR detectable by an EMR detector towards the material 101. The EMR emission/detection system may include any of a camera, a laser diode-detector pair, automated optical inspection, automated UV/IR inspection, or automated X-radiation (X-ray) inspection.

[0041] An inspection system 170 may include a marking system 171 arranged so as to mark the sections of the material where a measured value deviates from a predefined range of allowable values. The deviation may represent a flaw, a quantity of a foreign substance, or a quantity of a pathogen on the material 101. Such deviation may indicate a controlled characteristic of the material is outside of an allowable condition. Inspection may examine transmitted or reflected electromagnetic radiation to detect defective areas. A marking system 171 may include a hot or cold embossing system, a gravuring system, an etching system, a sterile lithography process, or an equivalent system and may mark a section of the material according to system input regarding the controlled characteristic.

[0042] The demarcation by the marking system 171 may be detectable by an inspection system included in a subsequent process apparatus such as a thermoforming apparatus, a heat welding apparatus, or a lamination apparatus. Detection of a demarcation by a subsequent process may be conducted by a process operator or technician, or may be conducted by an inspection system of a including one or more of an electronic vision system comprising any of a camera, a laser diode and detector, automated optical inspection, automated UV/1R inspection, automated X-ray inspection. Such inspection may be configured to examine transmitted or reflected electromagnetic radiation to detect marked areas.

[0043] The material treatment apparatus 1000 of Fig. 1A may optionally include a repair system 160 configured to repair damage to a surface of a material 101. A portion of the material 101 may incur damage from any treatment applied to the material, including treatment by the expulsion of a particulate jet in treatment system 140. Damage may include surface damage such as pitting or scarring of a material 101 comprising a web material. The repair system 160 may repair the material 101 (e.g., repair damage resulting from the treatment system), such as a web material, by heating the surface of the material 101 in a controlled fashion. For many materials including polymeric web materials, controlled heating may increase plasticity of a portion of the material 101 such that any pitting, scarring, divots, tears, or cracks may be reduced or eliminated to reconstitute a smooth surface. The repair system 160 may heat a material 101 in a controlled fashion by infrared radiation, by a flow of heated gas across the material, and/or by passing the material across a hot roller or iron. The repair system 160 may include one or more of a surface heater, heating fluid source, or an infrared radiation source.

[0044] A material treatment apparatus 1000 may include a material guidance system 180 configured to guide the material 101 onto the second reel 100 to provide consistent alignment of a material 101 on a second reel 100. [0045] Other treatments applied to the material 101 by the material treatment apparatus 1000 may optionally include one or more of corona treatment, UV treatment, vibration, particle cleaning using sticky rollers, washing with a surfactant, washing with sterilized water, exposure to ionized air, electron beam radiation, or x-ray treatment. The system may further comprise an arrangement for replacing a first reel 110 (e.g., an upstream reel) and/or a second reel 100 (e.g., a downstream reel) without compromising the treatment of the last section of the material on a reel. As illustrated in Figure IB, a material treatment apparatus 1010 may extend from a first region 1920 to a second region 1930. The first region 1920 may be disposed at an upstream end of the pathway followed by a material 1011, and the second region 1930 may be disposed at the downstream end of a pathway followed by a material 1011. The material treatment apparatus 1010 may include subsystems applying a plurality of treatments to a material 1011. The material treatment apparatus 1010 may comprise a material transport system configured to transit a material 1011 from a first region 1920 to a second region 1930 and through a fluid flow region 1500. The first region 1920 may include a first reel 1100, the second region 1930 may include a second reel 2000, and/or both reels may be included in the material transport system. The material transport system or material mover may be configured as a reel-to-reel transport system able to transport a sheet of material that is flexible and substantially planar, and may be configured to accommodate a material comprising a formed section in some embodiments.

[0046] The first region 1920 of the material treatment apparatus 1010 in Fig. IB may be maintained in a first state of cleanliness, and the second region 1930 of the material treatment apparatus may be maintained at a second state of cleanliness greater than the first state of cleanliness. The state of cleanliness may be defined by a lower particle count or pyrogen count in the second region 1930 or may be defined by a lower degree of biological risk in the second region 1930. The second region 1930 may meet a more rigorous particle count standard according to ISO 14644 or any equivalent or succeeding particle count standard. The second region 1930 may meet a more rigorous biocontamination control standard according to ISO 14698 or an equivalent or succeeding biocontamination control standard.

[0047] The material treatment apparatus 1010 may include a particulate removal system 1200, which may comprise a primary particulate removal roller configured to contact the material 1011 to remove particulates from the portion of the material 1011, and a secondary particulate removal roller configured to contact the primary particulate removal roller to remove particulates from the primary particulate removal roller. The primary particulate removal roller may be a rubberized roller configured to leave substantially no residue when contacting the material 1011, and the secondary particulate removal roller may be a sticky roller with a sticky material on a surface of the secondary particulate removal roller configured to roll over the primary particulate removal roller.

[0048] A treatment system 1400 may be disposed along the pathway of the material 1011 between the first region 1920 and the second region 1930. The treatment system 1400 may include one or more fluid feed lines, one or more nozzles, and one or more jets comprising a treatment substance. The treatment system 1400 may remove particles from a portion of the material 1011. The portion of the material 1011 downstream from the treatment system 1400 may be in a treated condition.

[0049] The material treatment apparatus 1010 of Fig. IB may include a fluid flow region 1500 extending along a portion of the pathway of the material from a downstream end to an upstream, and may surround the material pathway. A flow of fluid, including a gaseous flow, may be directed through a conduit 1510 and across the material in the upstream direction. The fluid flow region 1500 may include an airflow system such as an air knife, or airflow may be provided by a positive pressure environment in the second region 1930. The flow of fluid through the fluid flow region 1500 may maintain a relatively cleaner state of cleanliness in the downstream end of the fluid flow region 1500 relative to the upstream end. The flow of fluid (e.g., of the treatment substance) may include a gaseous flow of air, nitrogen, carbon dioxide, water, argon, a combination thereof, or any equivalent composition. Such flow of fluid may entrain removed particles such as those removed by a treatment system 1400. and transport them to and/or past the upstream end of the fluid flow region or of the treatment system 1400.

[0050] The flow of fluid through the fluid flow region 1500 may flow into a removed particle treater to convey removed particles through the removed particle treater. A removed particle treater may ensure removed particles are in a predefined condition, such as a condition of being chemically decomposed, denatured, or rendered biologically inert. The conduit 1510 may include a flow of fluid 1800 at the upstream end of the material pathway. Such a flow of fluid may be produced by an airflow system or may be provided by positive pressure in the second region 1930.

[0051] The second region 1930 may comprise an isolator, a glovebox, a cleanroom, a Restricted Access Barrier System (RABS), or another enclosure, and such an enclosure may facilitate maintaining the second region 1930 in the cleaner second state of cleanliness.

[0052] Fig. IB includes a demarcation line 1921, indicating an arrangement of a boundary between a first region 1920 and a second region 1930. As illustrated by the demarcation line 1921, the second region includes a conduit 1510. In another variation, the conduit 1510 may be disposed entirely outside the second region 1930. Either arrangement may be configured to prevent the intrusion of removed particles into the second region 1930 and/or maintain that the presdefined state of cleanliness of the second region 1930.

[0053] The material treatment apparatus 1010 may include one or more tensioning systems arranged to maintain a substantially constant tension throughout the material 1011 along the material pathway. A tensioning system may comprise a roller 1830 and tensioning element 1810, such as a spring, pneumatic pump, or hydraulic pump. A second tensioning system may also be disposed along the material pathway and may comprise a roller 1820 and a tensioning element 1840.

[0054] The material 1011 may comprise a flexible and substantially planar polymer web and may be unwound or unspooled from a first reel 1100 in the first region 1920 prior to applying a treatment and rewound or spooled onto a second reel 2000 in the second region 1930 after applying a treatment. Such a material 1011 may be packaged at the second region 1930 such that its treated condition is maintained in the second region 1930. In some variations of the material treatment apparatus 1010, the material 1011 may include a formed section or sections, such as thermoformed shapes extending out of the plane of the material.

[0055] The material treatment apparatus may optionally include an inspection system 1700, which may inspect the material 1011 for a predefined measured value indicating information about a controlled characteristic of the portion of the material 1011. Such a measured value may be any of material cleanliness, visible particle count, visible pyrogen count, damage, physical parameters such as temperature or light transmission, treatment inconsistencies, or other measurable value which may indicate information about the material 1011. Inspection may take the form of an electronic vision system detecting electromagnetic radiation (EMR), which may include any of a camera, a laser diode-detector pair, an automated optical inspection, an automated UV/IR inspection, or an automated X-ray inspection.

[0056] An inspection system 1700 may communicate with a marking system 1750 arranged so as to mark the sections of the material where a measured value deviates from a set range of allowable values. Such deviation may indicate a controlled characteristic of the material is outside of an allowable condition. Inspection may examine transmitted or reflected electromagnetic radiation to detect defective areas. A marking system 1750 may include a hot or cold embossing system, a gravuring system, an etching system, a sterile lithography process, or an equivalent system and may mark a section of the material according to system input regarding the controlled characteristic.

[0057] The demarcation by the marking system 1750 may be detectable by an inspection system included in a subsequent process apparatus such as a thermoforming apparatus, a heat welding apparatus, or a lamination apparatus. Detection of a demarcation by a subsequent process may be conducted by a process operator or technician, or may be conducted by an inspection system, including one or more of an electronic vision system comprising any of a camera, a laser diode and detector, automated optical inspection, automated UV/IR inspection, automated X-ray inspection. Such inspection may be configured to examine transmitted or reflected electromagnetic radiation to detect marked areas.

[0058] The material treatment apparatus 1010 of Fig. IB may optionally include a repair system configured to repair damage to a surface of a material, substantially as previously described.

[0059] The material treatment apparatus 1010 may optionally apply additional treatments to the material 1011 at a secondary treatment system 1450. Treatment by a secondary treatment system 1450 may include one or more of corona treatment, UV treatment, vibration, particle cleaning using sticky rollers, washing with surfactant, washing with sterilized water, exposure to ionized air, electron beam radiation, or x-ray treatment. The system may further comprise an arrangement for replacing a first reel 1100 at an upstream end and/or a second reel 2000 at a downstream end without compromising the treatment of the last section of the material on a reel.

[0060] The second region 1930 may include one or more material processing apparatus 1940, such as a thermoforming apparatus, a heat welding apparatus, a lamination apparatus, a fill-seal apparatus, or a form-fill-seal apparatus. Alternatively, the one or more material processing apparatus 1940 may be located in a different region of substantially the same state of cleanliness as or a cleaner state of cleanliness relative to the second region 1930.

[0061] Figure 2 illustrates a particulate removal system 200. A material treatment apparatus may include a particulate removal system 200, which may comprise primary particulate removal rollers 227 and 229 configured to contact the material 201 on either surface to remove particulates from the contacted portion of the material 201. The particulate removal system 200 may include secondary particulate removal rollers 226 and 228 configured to contact the primary particulate removal rollers 227 and 229 to remove particulates from the primary particulate removal rollers 227 and 229. The primary particulate removal rollers 227 and 229 may be rubberized rollers configured to leave substantially no residue when contacting the material 201, and the secondary particulate removal rollers 226 and 228 may be sticky rollers with a sticky material on their surfaces configured to roll over the primary particulate removal rollers 227 and 229. The rollers may be arranged in roller sets 220 and 221, as shown, and disposed on either surface of a material 201, which may be flexible and substantially planar.

[0062] The particulate removal system 200 may be disposed relative to one or more airflow systems 224 and 225, which may comprise air knives. The one or more airflow systems 224 and 225 may provide a flow of air to entrain particles de-adhered from the material 201 and flow such particles away from the downstream end of the material 201.

[0063] Figure 3 illustrates vibrational cleaning system 300 comprising a housing 330, a static charge neutralizing ion flow 332, and comprising air out-flow lines 335 and 337 and an air in-flow line 336 configured to vibrate the material 301 such that surface particulates such as pyrogens are de-adhered from the material. Put another way, the sub-system sonicates the material 301 in air to shatter weakly adhered surface features such that they may be removed by air supplied by the air out-flow lines 335 and 337. It should be appreciated that substances other than air may be used.

[0064] Figures 4A&B illustrate a treatment system 400 comprising a substance expulsion system configured to treat the material 401 by expulsion of treatment substances 448 and 449, which may comprise the same treatment substance, onto a portion of the material 401 in the form of particulate jets 446 and 447. Nozzles 440 and 441 may be disposed relative to the material 401 such that particulate jets 446 and 447 expel a treatment substance 448 to treat an entire transverse width 402 of the material 401. The nozzle arrangement may be arrayed act on both sides (e.g., each of a first surface of the portion of the material and a second surface of the portion of the material on an opposite side of the sheet of the material from the first surface) of material 401, and the material 401 may comprise a sheet of material that is flexible and substantially planar. A material 401 may include a film, web, formed section, device component element, whole device component, or whole device. In some variations, the nozzles 440 and 441 may be arrayed vertically or sequentially in relation to the long axis of the material 401. A nozzle 440 or 441 may be supported by a support apparatus which may comprise a connecter connected to the nozzle 440 or 441 or a tube 442 or 443 configured to convey a treatment substance 448 or 449 from a storage system to the nozzles 440 and 441.

[0065] When the treatment substance feed system is activated, the nozzles 440 and 441 may generate a frozen particle stream which may then act on the surface of the material 401. A treatment substance feed system may comprise a pressurized fluid feed which may pressurize a treatment substance, or a treatment substance may be provided under pressure. In embodiments comprising a pressurized fluid feed, a flow of pressurized fluid may mix with a flow of treatment substance. The mixed flow may be controlled by controlling the characteristics of the initial treatment substance flow or by controlling the characteristics of the pressurized fluid feed.

[0066] The treatment system 400 may operate under varying conditions of material speed along the material pathway. The material speed may be any value, for example, in the range from 10 millimeters per second (mm/s) to 1,000 mm/s (e g., millimeters per second of sheet material length extending in the upstream or downstream direction) and may include subranges. Examples of material speed subranges include ranges between a first value and second value of the values 25 mm/s, 40 mm/s, 62.5 mm/s, 85 mm/s, 100 mm/s, or 1,000 mm/s. The treatment system 400 may operate under varying conditions of pressurized fluid pressure, for example, from 5 pounds per square inch (psi) to 1,500 psi, and may operate at set subranges. Examples of pressurized fluid pressure subranges include ranges between a first value and second value of the values 22 psi, 25 psi, 30 psi, 34 psi, 37 psi, or 1,500 psi. The treatment system 400 may operate under varying conditions of pressurized fluid temperature, for example, from 0°C to 200°C, and may operate at set subranges. Examples of pressurized fluid temperature subranges include ranges between a first value and second value of the values 0°C, 60°C, 70°C, 85°C, 110°C, or 200°C.

[0067] A treatment system 400 may comprise a fluid flow region 455, including a conduit 450, which may include a first conduit wall 451 and a second conduit wall 452. The fluid flow region may include a fluid flow generator 424 and 425 configured to provide the flow of fluid through the conduit 450 and across the material 401. A fluid flow region 455 may extend along a pathway of the material 401 from an upstream section 403 to a downstream section 404 and may surround the material pathway. A flow of fluid, such as a gaseous flow, may be directed through a conduit 450 and across the material in the direction of the upstream section 403. In this way, the fluid flow can be configured to maintain a relatively cleaner state of cleanliness in the downstream section 404 relative to the upstream section 403. The fluid flow may include a gaseous flow of air, nitrogen, carbon dioxide, argon, or any equivalent composition. Such fluid flow may be capable of entraining removed particles and transporting them to and/or past the upstream end of the fluid flow region. A gaseous flow may be produced by an elevated pressure in the downstream end or by an apparatus such as an air knife or its equivalents. [0068] The material 401 may comprise an upstream section 403 and downstream section 404. The material 401 may transit from a first region to a second region through the fluid flow region 455, and the second region may be maintained at a higher relative cleanliness. A material transfer system reel-to-reel apparatus passes the film between the nozzle array, allowing the frozen matter streams to act on the whole length of a roll of film material.

[0069] As shown in Figure 4B, the nozzle arrangement may be arrayed act on both sides of material 401, the arrangement being such that the particulate jets 446 and 447 expel a treatment substance 448 to treat an entire transverse width 402 of the material 401. As illustrated, the material 401 may comprise a sheet of material that is flexible and substantially planar.

[0070] In one embodiment of the treatment system 400, the treatment substances 448 and 449 may comprise cleaning substances such as sterile water for injection, bacteriostatic water, normal saline, or a water-based detergent mixture. The treatment substances 448 and 449 may comprise a sterilizing agent capable of denaturing biological compounds present on a surface of the material 401. Such a sterilizing agent may include isopropyl alcohol, mixtures thereof, or other alcohols, acetone, mixtures thereof, or other ketones, benzene, mixtures thereof, or other biologically active hydrocarbons, detergents including anti-microbial detergents and water based detergent mixtures, and any equivalent. In some embodiments, the mechanical action of the particulate jets 446 and 447 of the treatment substances 448 and 449 may act to dislodge contaminating matter from a surface of the material 401 and may thereby act to treat the surface of the material 401 by cleaning, sterilization, or depyrogenation.

[0071] Figure 5 illustrates a repair system 500, including heating sources 560 and 561 configured to repair defects in a material 501. Such a system may be configured to repair defects in a material 501 before the material 501 passes through an inspection system such as that of Fig. 6, or may be configured to selectively activate to repair defects a portion of the material 501 detected by an inspection system such as that of Fig. 6. The heating sources 560 and 561 may include a surface heater, a heating fluid source such as a heat gun, or an infrared radiation source such as a resistive heating element. The rollers 562 and 562 may include heating sources such as a surface heating source in direct contact with a surface of a material 501. The path of a material 501 through the repair system 500 and along the rollers 562 and 563 may comprise any angle, including the substantially right angle as shown, or may pass directly through the rollers with no change in the path direction. As with the systems illustrated throughout this disclosure, the repair system 500 may be disposed in ambient laminar flow conditions 565.

[0072] Figure 6 illustrates an inspection system 600 which may include an electromagnetic radiation (EMR) detector 672 configured to detect any controlled characteristic of a material 601. Such a characteristic may be any of material cleanliness, visible particle count, visible pyrogen count, surface damage to the material 601, or other physical parameters such as temperature or light transmission, treatment inconsistencies, and any other controllable characteristic of the material. The EMR detector 672 may detect flaws in the material 601, or detect a foreign substance on the material 601, or detect a pathogen on the material 601. The EMR detector 672 may detect any of ultraviolet radiation, infrared radiation, visible light, or x-ray radiation. An inspection system 600 may be positioned to inspect the material 601 in laminar flow 665.

[0073] In some embodiments, the inspection system 600 may include an EMR emitter configured to emit EMR detectable by the EMR detector, and the emitted EMR may reflect, re-emit from, or be transmitted through the material to the EMR detector 672. Whether produced by an EMR emitter or by an ambient environment, the EMR detected by the EMR detector 672 may be modulated by the material 601 such that a controlled characteristic may be measured by the EMR detector 672. The inspection system 600 may include a marking system 680 configured to mark a defective portion of the material 601 based on the inspection of the inspection system.

[0074] The inspection system 600 may further comprise a marking system 680 arranged so as to mark a section of the material 601 inspected by the inspection system 600 and determined to be unsuitable according to a measured value of a controlled characteristic. The marking system 680 may mark a section of the material 601 wherein any of material cleanliness, visible particle count, visible pyrogen count, surface damage to the material 601, or other physical parameters such as temperature or light transmission, treatment inconsistencies, and any other controllable characteristic of the material have been determined by the inspection system 600 to fail an inspection condition (e g., deviate unacceptably from a prescribed threshold value or range of values). A marking system 680 may comprise a hot or cold embossing system, a gravuring system, an etching system, a sterile lithography process, or an equivalent system and may mark a section of the material according to system input regarding the controlled characteristic. In the illustrated embodiment, a marking system 680 may comprise a demarcation element 676, an actuator 679, and a mount 678. The demarcation element 676 may include a roller, a stamp, a heating element, a hot or cold embossing system, a gravuring system, an etching system, a sterile lithography system or an equivalent marking system. The marking system 680 may be controlled by a control system 670 which may receive an input signal from the EMR detector 672 by a connection 674 and produce and transmit an output signal to the marking system 680 by a connection 675. The output signal may be a modulation of voltage by amplitude or frequency. The output signal may control the action of an actuator 679 to cause actuation 677 of a demarcation element 676 into or out of contact with a surface of the material 601. The output signal may control the activation of a roller, a heating element, a hot or cold embossing system, a gravuring system, an etching system, a sterile lithography system or an equivalent marking system.

[0075] A demarcation produced by the marking system 680 may be detectable by an analogous inspection system included in a subsequent process system such as a thermoforming apparatus, a heat welding apparatus, or a lamination apparatus. Inspection may be conducted by a process operator or technician, or such inspection system may comprise an electronic vision system comprising any of a camera, a laser diode and detector, an automated optical inspection, an automated UV/IR inspection, or an automated X-ray inspection. Such inspection may be configured to examine transmitted or reflected electromagnetic radiation to detect marked areas.

[0076] Figure 7 illustrates a section 700 of the second region of a material treatment apparatus maintained at a second higher state of cleanliness relative to a first region. The section 700 may include a downstream reel 799 comprising the material 701 after treatment, and the downstream reel 799 may be maintained at a higher relative state of cleanliness relative to the upstream section of the material 701 prior to the application of treatments as described throughout the disclosure. The section 700 may include a material guidance system 780 to guide the material 701 onto the downstream reel 799 to provide consistent alignment of the sheet of material 701 around a downstream reel 799.

[0077] Figure 8 illustrates an exemplary method 800 of treating a material according to the teachings of the disclosure. The method comprises transiting a material along a material pathway extending from a first region to a second region 810, treating the material by expulsion of a treatment substance onto a portion of the material prior to the portion of the material transiting to the second region 820, transiting the material through along the material pathway through a fluid flow region between the first region and the second region, the fluid flow region including a flow of fluid across the material 830, and transiting the material to the second region while maintaining the second region at a state of cleanliness such that the treated condition of the material is maintained as the material transits into the second region 840. The order of the steps of the method may be rearranged, for example the material may be transited through the fluid flow, including a flow of fluid across the material prior to treating the material by expulsion of a treatment substance onto a portion of the material. This may be advantageous when the flow of fluid across the material comprises a pretreatment to treatment by the treatment substance. As an example, a flow of fluid may be configured to vibrate or sonicate a material such that particulates bound to a surface of a material de-adhere from the surface.

[0078] In implementations of the methods described herein in Fig. 8, the treating may optionally include maintaining the first region at a first state of cleanliness, the state of cleanliness of the second region being a relatively cleaner state of cleanliness. This may be advantageous for ensuring the treated condition of the material, such as a treated condition comprising a lower surface particulate count relative to the pre-treated condition of the material, may be maintained in the second region. The less clean state of cleanliness of the first region may include the pre-treated state of the material as it transits the first region.

[0079] In implementations of the methods described herein in Fig. 8, the treating may optionally include treating the material by expulsion of a treatment substance onto a portion of the material occurs prior to transiting the material along the material pathway through the fluid flow region. This may be advantageous for arranging the fluid flow of the fluid flow region such that it may entrain removed material removed by treating the material and carry such removed material away from downstream end of the fluid flow region and/or the second region.

[0080] In implementations of the methods described herein in Fig. 8, the treating may optionally include maintaining the fluid flow region at substantially the same state of cleanliness as the second region. This may be advantageous for the material in the treated condition may be maintained in the treated condition during transit along the material pathway between an upstream end of the fluid flow region and the second region.

[0081] In implementations of the methods described herein in Fig. 8, the material optionally includes a sheet of material that is flexible and substantially planar. This may be advantageous for treating material that may serve as a process precursor for process stages, including thermoforming, heat welding, lamination, or form-fill-seal operations.

[0082] In implementations of the methods described herein in Fig. 8, the material optionally includes a formed section. This may be advantageous for treating material at an intermediate process stage between a first process stage, such as thermoforming, heat welding, or lamination, and a second process stage, such as sterile fill or fill-seal operations.

[0083] In implementations of the methods described herein in Fig. 8, the fluid flow region optionally includes a flow of fluid directed across a downstream section of the material towards an upstream section of the material. This may be advantageous to ensure the downstream section of the material is maintained in the treated condition.

[0084] In implementations of the methods described herein in Fig. 8, the flow of fluid is optionally directed from the second region to the first region. This may be advantageous to ensure the second region is maintained in a relatively cleaner state of cleanliness.

[0085] In implementations of the methods described herein in Fig. 8, the treatment substance optionally includes carbon dioxide, and the expulsion of the treatment substance forms a jet, including solid or liquid carbon dioxide particles. This may be advantageous due to favorable characteristics of carbon dioxide for the formation of particulate jets by Joule-Thompson cooling.

[0086] In implementations of the methods described herein in Fig. 8, the jet optionally removes particulates from a portion of the material. This may be advantageous due to the relative efficacy of a frozen material jet in removing particulates from a surface.

[0087] In implementations of the methods described herein in Fig. 8, the treating optionally includes treating the removed particles removed from the portion of the material by the jet. This may be advantageous to ensure that the removed particles are in a predefined condition, such as a condition of being chemically decomposed, denatured, or rendered biologically inert.

[0088] In implementations of the methods described herein in Fig. 8, the treating optionally includes treating the removed particles by any of ultraviolet radiation, gamma radiation, other EMR, heating, incineration (e.g., by an incinerator), or a sterilizing fluid application (e.g., by a sterile fluid applicator). This may be advantageous to ensure that the removed particles are in a predefined condition, such as a condition of being chemically decomposed, denatured, or rendered biologically inert.

[0089] In implementations of the methods described herein in Fig. 8, the methods optionally include providing, by a source reel of a reel system, the sheet of material to the first region prior to the transiting. This may be advantageous for the efficient handling of a material that is flexible and substantially planar and for the maintenance of tension in such material. [0090] In implementations of the methods described herein in Fig. 8, the methods optionally include receiving, by a downstream reel of the reel system, a sheet of material after the treating. The downstream reel may be positioned in the second region. This may be advantageous for the efficient handling of a material that is flexible and substantially planar and for the maintenance of tension in such material. This may also be advantageous for the efficient transfer of the material in a treated condition to a subsequent process stage, including thermoforming, heat welding, lamination, or form-fill-seal operations.

[0091] In implementations of the methods described herein in Fig. 8, the sheet of material may optionally include a polymer layer. This may be advantageous for the production of formed materials, device component elements, whole device components, or devices, including a material with a polymer layer.

[0092] In implementations of the methods described herein in Fig. 8, the treating optionally includes expelling the treatment substance onto an entire transverse width of the portion of the material. This may be advantageous for ensuring that substantially the entire material downstream of the treatment system may be in the treated condition.

[0093] In implementations of the methods described herein in Fig. 8, the treating optionally includes expelling the treatment substance onto an entire transverse width of each of a first surface of the portion of the material and a second surface of the portion of the material on an opposite side of the sheet of material from the first surface.

[0094] In implementations of the methods described herein in Fig. 8, the treating is optionally conducted by a treatment system, including at least one nozzle and a substance source configured to provide the treatment substance to the at least one nozzle for the expulsion. This may be advantageous for directing the substance toward a surface of the material to be treated.

[0095] In implementations of the methods described herein in Fig. 8, the treatment substance optionally includes a pressurized fluid at a first pressure higher than a second pressure of an environment of the fluid flow region in which the portion of the material receives the treatment substance from the expulsion, the expulsion based on the first pressure and the second pressure. This may be advantageous for the creation for cooled solid or liquid particles to form a particle jet.

[0096] In implementations of the methods described herein in Fig. 8, optionally, a difference between the first pressure and the second pressure at least partially transitions the treatment substance from a fluid state to a solid state during the treating. [0097] In implementations of the methods described herein in Fig. 8, the second pressure is optionally at or below atmospheric pressure.

[0098] In implementations of the methods described herein in Fig. 8, the treating may optionally include directing the at least one nozzle to direct the treatment substance at the portion of the material in an upstream direction. This may be advantageous to ensure the downstream section of the material is maintained in the treated condition.

[0099] In implementations of the methods described herein in Fig. 8, the portion of material optionally includes a sheet of material, and the at least one nozzle optionally includes a first nozzle and a second nozzle. The treating may include directing a first nozzle at a first side of the sheet of material and directing a second nozzle at a second side of the sheet of material opposite the first side. This may be advantageous for treating substantially the entire surface area of a material, including a material that is flexible and substantially planar.

[0100] In implementations of the methods described herein in Fig. 8, the methods optionally include modifying an orientation of the at least one nozzle relative to the portion of the material. This may be advantageous for treating an entire transverse width of the material using fewer nozzles than in the case of a fixed nozzle array. This may be unneeded when a single nozzle or a fixed nozzle array may treat an entire transverse width of the material.

[0101] In implementations of the methods described herein in Fig. 8, the fluid flow region optionally further includes a conduit. The treating may include flowing the flow of fluid through the conduit and expelling the treatment substance onto the portion of the material within the conduit. This may be advantageous for controlling the flow of the fluid of fluid through the fluid flow region, for maintaining the second region in a relatively cleaner state of cleanliness, and/or for maintaining the downstream section of the material in the treated condition.

[0102] In implementations of the methods described herein in Fig. 8, the methods optionally include producing the flow of fluid using an air knife.

[0103] In implementations of the methods described herein in Fig. 8, any fluid communication between the second region and the first region may optionally be via the conduit.

[0104] In implementations of the methods described herein in Fig. 8, the methods optinally include flowing a filtered fluid filtered by HEPA filtration through the second region. [0105] In implementations of the methods described herein in Fig. 8, the methods optionally include flowing the fdtered fluid with the flow of fluid through the fluid flow region.

[0106] In the methods described herein in Fig. 8, the treating may optionally include treating the material at least a second time when the material is in transit along the material pathway by any of: removing particulates from the material surface by adhesion to a contacting surface; or vibrating the material surface and removing vibrationally de-adhered particulates with negative pressure; or inspecting a surface of the material and marking a portion of the material when an inspected characteristic meets a certain value or range; or repairing a surface of a material using a heat treatment.

[0107] In implementations of the methods described herein in Fig. 8, the treating may optionally include contacting, by a primary particulate removal roller, the material to remove particulates from the portion of the material.

[0108] In the methods described herein in Fig. 8, the treating may optionally include contacting, by a secondary particulate removal roller, the primary particulate removal roller to remove particulates from the primary particulate removal roller.

[0109] In implementations of the methods described herein in Fig. 8, the primary particulate removal roller may optionally be a rubberized roller configured to leave substantially no residue when contacting the material, and/or the secondary particulate removal roller may optionally be a sticky roller with a sticky material on a surface of the secondary particulate removal roller configured to roll over the primary particulate removal roller.

[0110] In implementations of the methods described herein in Fig. 8, the treating may optionally include inspecting, by an inspection system, the portion of the material after the treating by determining whether the portion of the material satisfies a quality condition. This may be advantageous for ensuring the material is in the treated condition prior to a subsequent process stage, such as thermoforming, heat welding, lamination, or form-fill-seal operations.

[0111] In the methods described herein in Fig. 8, the treating may optionally include detecting, by an electromagnetic radiation (EMR) detector, a flaw in the portion of the material, a foreign substance on the portion of the material, or a pathogen on the portion of the material. This may be advantageous for allowing the repair or demarcation of sections of a material that fail to satisfy the quality condition due to a flaw in the portion of the material, a foreign substance on the portion of the material, or a pathogen on the portion of the material. [0112] The methods described herein in Fig. 8 may optionally include treating material, wherein the EMR detector detects at least one of ultraviolet radiation, infrared radiation, visible light, or X- Radiation.

[0113] The methods described herein in Fig. 8 may optionally include emitting, by an EMR emitter, EMR detectable by the EMR detector towards the portion of the material.

[0114] The methods described herein in Fig. 8 may optionally include marking a defective portion of the material based on the inspection of the inspection system. This may be advantageous for ensuring a subsequent process stage may avoid a defective portion of the material.

[0115] In implementations of the methods described herein in Fig. 8, the marking may optionally include embossing, providing a gravure, etching, or sterile lithography of the defective portion. This may be advantageous for ensuring a subsequent process stage may avoid a defective portion of the material. This may further avoid comprising the cleaner state of cleanliness of the second region, and/or may ensure that non-defective portions of the material in the treated condition remain in a non-defective treated condition.

[0116] In implementations of the methods described herein in Fig. 8, the methods optionally include repairing defects in the portion of the material detected by the inspection system.

[0117] In implementations of the methods described herein in Fig. 8, repairing the material optionally includes modifying the defective portion by a surface heater, a heating fluid source, or an infrared radiation source.

[0118] In implementations of the methods described herein in Fig. 8, the methods optionally include neutralizing removed elements removed from the portion of the material by the expulsion to satisfy a safety standard.

[0119] In implementations of the methods described herein in Fig. 8, the neutralizing optionally includes applying ultraviolet radiation, gamma radiation, a different EMR, heat, an incinerator, or a sterilizing fluid to the removed elements.

[0120] In implementations of the methods described herein in Fig. 8, the treatment substance may optionally include carbon dioxide, argon, water, nitrogen, or a combination thereof.

[0121] In implementations of the methods described herein in Fig. 8, the expulsion may optionally at least one of remove particulates from, depyrogenate, or sterilize the portion of the material. 1 [0122] In implementations of the methods described herein in Fig. 8, the second region may optionally be aseptic, and the first region may optionally not be aseptic.

[0123] In implementations of the methods described herein in Fig. 8, the flow of fluid may optionally be provided in a laminar flow over the portion of the material.

[0124] In implementations of the methods described herein in Fig. 8, the methods may optionally include washing the portion of the material with a surfactant, sterilized water, or ionized air.

[0125] In implementations of the methods described herein in Fig. 8, the methods may optionally include exposing the portion of the material to X-radiation.

[0126] In implementations of the methods described herein in Fig. 8, the methods may optionally include vibrating the portion of the material to remove particulates.

[0127] In implementations of the methods described herein in Fig. 8, the methods may optionally include exposing the portion of the material to electron beam radiation.

[0128] In implementations of the methods described herein in Fig. 8, the transiting may optionally include vertically orienting the portion of the material, and the treating may optionally include expelling the treatment substance at the portion of the material in an at least partially downward direction.

[0129] In implementations of the methods described herein in Fig. 8, the material may optionally include a removable layer, and the expulsion may optionally include expelling the treatment substance to at least partially remove the removable layer from the portion of the material.

[0130] Any embodiment of the apparatus for treating a material described herein may include a material pathway extending between a first region and a second region, a treatment system configured to treat the material by expulsion of a treatment substance onto a portion of the material transiting from the first region to the second region along the material pathway; and a fluid flow region in which a flow of fluid is directed across the material pathway, wherein the material transits along the material pathway from the first region to the second region through the fluid flow region; wherein the second region is maintained at a state of cleanliness, the state of cleanliness being such that the treated condition of the material is maintained when the material transits along the material pathway from treatment system to the second region. [0131] Any embodiment of the apparatus for treating a material described herein may include the first region maintained at a first state of cleanliness, the state of cleanliness of the second region including a relatively cleaner state of cleanliness.

[0132] Any embodiment of the apparatus for treating a material described herein may include the treatment system is configured to treat the material prior to the material transiting along the material pathway through the fluid flow region.

[0133] Any embodiment of the apparatus for treating a material described herein may include the fluid flow region is maintained at substantially the same state of cleanliness as the second region.

[0134] Any embodiment of the apparatus for treating a material described herein may include the material includes a sheet of material that is flexible and substantially planar.

[0135] Any embodiment of the apparatus for treating a material described herein may include the material includes a formed section.

[0136] Any embodiment of the apparatus for treating a material described herein may include the flow of fluid is directed across the material from a downstream section of the material to an upstream section of the material.

[0137] Any embodiment of the apparatus for treating a material described herein may include the flow of fluid is directed from the second region to the first region.

[0138] Any embodiment of the apparatus for treating a material described herein may include the treatment substance includes carbon dioxide, the expulsion of the substance forming a jet including solid or liquid carbon dioxide particles.

[0139] Any embodiment of the apparatus for treating a material described herein may include the jet is configured to remove particulates from a portion of the material.

[0140] Any embodiment of the apparatus for treating a material described herein may include: a removed particle treater configured to treat removed particles the treatment system removes from the portion of the material by the expulsion.

[0141] Any embodiment of the apparatus for treating a material described herein may include the removed material treater includes an ultraviolet radiation emitter, a gamma radiation emitter, other EMR emitter, a heat source, an incinerator, or a sterilizing fluid applicator. [0142] Any embodiment of the apparatus for treating a material described herein may include: a material mover configured to provide the transit of the sheet of material from the first region to the second region, the material mover including a source reel configured to provide the sheet of material to the first region.

[0143] Any embodiment of the apparatus for treating a material described herein may include the material mover further includes: a downstream reel positioned within the second region and configured to receive the sheet of material after the treatment system treats the sheet of material.

[0144] Any embodiment of the apparatus for treating a material described herein may include that the sheet of material includes a polymer layer.

[0145] Any embodiment of the apparatus for treating a material described herein may include the treatment system is configured to expel the treatment substance to treat an entire transverse width of the portion of the material.

[0146] Any embodiment of the apparatus for treating a material described herein may include the treatment system is configured to expel the treatment substance to treat an entire transverse width of each of a first surface of the portion of the material and a second surface of the portion of the material on an opposite side of the of the sheet of material form the first surface.

[0147] Any embodiment of the apparatus for treating a material described herein may include the treatment system includes at least one nozzle and a substance source configured to provide the treatment substance to the at least one nozzle for the expulsion.

[0148] Any embodiment of the apparatus for treating a material described herein may include the treatment substance includes a pressurized fluid at a first pressure higher than a second pressure of an environment of the fluid flow region in which the portion of the material receives the treatment substance from the expulsion.

[0149] Any embodiment of the apparatus for treating a material described herein may include a difference between the first pressure and the second pressure at least partially transitions the treatment substance from a fluid state to a solid state.

[0150] Any embodiment of the apparatus for treating a material described herein may include the second pressure is at or below atmospheric pressure. [0151] Any embodiment of the apparatus for treating a material described herein may include the at least one nozzle is configured to direct the treatment substance at the portion of the material in an upstream direction.

[0152] Any embodiment of the apparatus for treating a material described herein may include the portion of material includes a sheet of material, the at least one nozzle including: a first nozzle configured to be directed at a first side of the sheet of material; and a second nozzle configured to be directed at a second side of the sheet of material opposite the first side.

[0153] Any embodiment of the apparatus for treating a material described herein may include: an airflow system configured to provide the flow of fluid; and a conduit that at least partially defines the fluid flow region, wherein the treatment system expels the treatment substance onto a portion of the material within the fluid flow region, and the airflow system is configured to flow the flow of fluid through the conduit.

[0154] Any embodiment of the apparatus for treating a material described herein may include the airflow system includes an air knife.

[0155] Any embodiment of the apparatus for treating a material described herein may include any fluid communication between second region and the first region is via the conduit.

[0156] Any embodiment of the apparatus for treating a material described herein may include the second region includes a flow of filtered fluid filtered through a HEPA filtration system.

[0157] Any embodiment of the apparatus for treating a material described herein may include the flow of filtered fluid is included in the flow of fluid in the fluid flow region.

[0158] Any embodiment of the apparatus for treating a material described herein may include a second region, including any one of a Restricted Access Barrier System (RABS), a cleanroom isolator, or a glove box.

[0159] Any embodiment of the apparatus for treating a material described herein may include: at least one additional system disposed along the material pathway, the additional system including any of a particulate removal system, a vibrational treatment system, an inspection system, a marking system, or a repair system.

[0160] Any embodiment of the apparatus for treating a material described herein may include: a primary particulate removal roller configured to contact the material to remove particulates from the portion of the material. [0161] Any embodiment of the apparatus for treating a material described herein may include: a secondary particulate removal roller configured to contact the primary particulate removal roller to remove particulates from the primary particulate removal roller.

[0162] Any embodiment of the apparatus for treating a material described herein may include that the primary particulate removal roller is a rubberized roller configured to leave substantially no residue when contacting the material, and that the secondary particulate removal roller is a sticky roller with a sticky material on a surface of the secondary particulate removal roller configured to roll over the primary particulate removal roller

[0163] Any embodiment of the apparatus for treating a material described herein may include an inspection system configured to inspect the portion of the material after treatment of the portion of the material by determining whether the portion of the material satisfies a quality condition.

[0164] Any embodiment of the apparatus for treating a material described herein may include an inspection system including an electromagnetic radiation (EMR) detector configured to detect a flaw in the portion of the material, a foreign substance on the portion of the material, or a pathogen on the portion of the material.

[0165] Any embodiment of the apparatus for treating a material described herein may include the EMR detector detects at least one of ultraviolet radiation, infrared radiation, visible light, or X- Radiation.

[0166] Any embodiment of the apparatus for treating a material described herein may include an EMR emitter configured to emit EMR detectable by the EMR detector towards the portion of the material.

[0167] Any embodiment of the apparatus for treating a material described herein may include an inspection system, including a marking system configured to mark a defective portion of portion of the material based on the inspection of the inspection system.

[0168] Any embodiment of the apparatus for treating a material described herein may include the marking system includes an embossing system, a gravure system, an etching system, or a sterile lithography system.

[0169] Any embodiment of the apparatus for treating a material described herein may include: a repair system configured to repair defects in the portion of the material detected by the inspection system. [0170] Any embodiment of the apparatus for treating a material described herein may include the repair system includes a surface heater, a heating fluid source, or an infrared radiation source.

[0171] Any embodiment of the apparatus for treating a material described herein may include the treatment substance includes carbon dioxide, argon, water, nitrogen, or a combination thereof.

[0172] Any embodiment of the apparatus for treating a material described herein may include the treatment substance is configured to treat the portion of the material by the expulsion of a substance by at least one of removing particulates from, depyrogenation of, or sterilization of the portion of the material.

[0173] Any embodiment of the apparatus for treating a material described herein may include the second region is aseptic, and the first region is not aseptic.

[0174] Any embodiment of the apparatus for treating a material described herein may include the treatment system is configured to provide the treatment substance in a laminar flow on the portion of the material.

[0175] Any embodiment of the apparatus for treating a material described herein may include: a washing system configured to wash the portion of the material with a surfactant, sterilized water, or ionized air.

[0176] Any embodiment of the apparatus for treating a material described herein may include: an X-radiation treatment device configured to expose the portion of the material to X-radiation.

[0177] Any embodiment of the apparatus for treating a material described herein may include: a vibrational treatment system configured to vibrate a portion of the material to remove particulates.

[0178] Any embodiment of the apparatus for treating a material described herein may include: an electron beam radiation emitter configured to expose the portion of the material to electron beam radiation.

[0179] Any embodiment of the apparatus for treating a material described herein may include the portion of the material is oriented vertically and wherein the treatment system expels the treatment substance at the portion of the material in an at least partially downward, upstream direction.

[0180] Any embodiment of the apparatus for treating a material described herein may include the material includes a removable layer, and the treatment system is configured to expel the treatment substance to at least partially remove the removable layer from the portion of the material. [0181] Although the technology has been described in language that is specific to certain structures and materials, it is to be understood that the invention defined in the appended claims is not necessarily limited to the specific structures and materials described. Rather, the specific aspects are described as forms of implementing the claimed invention. Because many embodiments of the invention can be practiced without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

[0182] Unless otherwise indicated, all numbers or expressions, such as those expressing dimensions, physical characteristics, etc., used in the specification (other than the claims) are understood as modified in all instances by the term "approximately". At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the claims, each numerical parameter recited in the specification or claims which is modified by the term "approximately" should at least be construed in light of the number of recited significant digits and by applying rounding techniques. Moreover, all ranges disclosed herein are to be understood to encompass and provide support for claims that recite any and all sub-ranges or any and all individual values subsumed therein. For example, a stated range of 1 to 10 should be considered to include and provide support for claims that recite any and all sub-ranges or individual values that are between and/or inclusive of the minimum value of 1 and the maximum value of 10; that is, all sub-ranges beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less (e.g., 5.5 to 10, 2.34 to 3.56, and so forth) or any values from 1 to 10 (e.g., 3, 5.8, 9.9994, and so forth).

Claims

CLAIMS What Is Claimed Is:

1. An apparatus for treating material, the apparatus comprising: a material pathway extending between a first region and a second region, a treatment system configured to treat the material by expulsion of a treatment substance onto a portion of the material transiting from the first region to the second region along the material pathway; and a fluid flow region in which a flow of fluid is directed across the material pathway, wherein the material transits along the material pathway from the first region to the second region through the fluid flow region; wherein the second region is maintained at a state of cleanliness, the state of cleanliness being such that a treated condition of the material is maintained when the material transits along the material pathway from treatment system to the second region.

2. The apparatus for treating material of claim 1, wherein the first region maintained at a first state of cleanliness, the state of cleanliness of the second region comprising a relatively cleaner state of cleanliness.

3. The apparatus for treating material of claim 1, wherein the treatment system is configured to treat the material prior to the material transiting along the material pathway through the fluid flow region.

4. The apparatus for treating material of claim 1, wherein the fluid flow region is maintained at substantially a same state of cleanliness as the second region.

5. The apparatus for treating material of claim 1, wherein the material comprises a sheet of material that is flexible and substantially planar.

6. The apparatus for treating material of claim 5, wherein the material comprises a formed section.

7. The apparatus for treating material of claim 1, wherein the flow of fluid is directed across the material from a downstream section of the material to an upstream section of the material.

8. The apparatus for treating material of claim 1, wherein the flow of fluid is directed from the second region to the first region.

9. The apparatus for treating material of claim 1, wherein the treatment substance comprises carbon dioxide, the expulsion of the treatment substance forming a jet including solid or liquid carbon dioxide particles.

10. The apparatus for treating material of claim 9, wherein the jet is configured to remove particulates from a portion of the material.

11. The apparatus for treating material of claim 10, further comprising: a removed particle treater configured to treat removed particles the treatment system removes from the portion of the material by the expulsion.

12. The apparatus for treating material of claim 11, wherein the removed particle treater includes an ultraviolet radiation emitter, a gamma radiation emitter, other EMR emitter, a heat source, an incinerator, or a sterilizing fluid applicator.

13. The apparatus for treating material of claim 1, further comprising: a material mover configured to provide transit of the material from the first region to the second region, the material mover comprising an upstream reel configured to provide the material to the first region.

14. The apparatus for treating material of claim 13, wherein the material mover further comprises: a downstream reel positioned within the second region and configured to receive the material after the treatment system treats the material.

15. The apparatus for treating material of claim 5, wherein the sheet of material includes a polymer layer.

16. The apparatus for treating material of claim 5, wherein the treatment system is configured to expel the treatment substance to treat an entire transverse width of the portion of the material.

17. The apparatus for treating material of claim 5, wherein the treatment system is configured to expel the treatment substance to treat an entire transverse width of each of a first surface of the portion of the material and a second surface of the portion of the material on an opposite side of the sheet of material form the first surface.

18. The apparatus for treating material of claim 1, wherein the treatment system includes at least one nozzle and a substance source configured to provide the treatment substance to the at least one nozzle for the expulsion.

19. The apparatus for treating material of claim 18, wherein the treatment substance includes a pressurized fluid at a first pressure higher than a second pressure of an environment of the fluid flow region in which the portion of the material receives the treatment substance from the expulsion.

20. The apparatus for treating material of claim 19, wherein a difference between the first pressure and the second pressure at least partially transitions the treatment substance from a fluid state to a solid state.

21. The apparatus for treating material of claim 19, wherein the second pressure is at or below atmospheric pressure.

22. The apparatus for treating material of claim 18, wherein the at least one nozzle is configured to direct the treatment substance at the portion of the material in an upstream direction.

23. The apparatus for treating material of claim 18, wherein the portion of material includes a sheet of material, the at least one nozzle comprising: a first nozzle configured to be directed at a first side of the sheet of material; and a second nozzle configured to be directed at a second side of the sheet of material opposite the first side.

24. The apparatus for treating material of claim 1, further comprising: an airflow system configured to provide the flow of fluid; and a conduit that at least partially defines the fluid flow region, wherein the treatment system expels the treatment substance onto a portion of the material within the fluid flow region, and the airflow system is configured to flow the flow of fluid through the conduit.

25. The apparatus for treating material of claim 24, wherein the airflow system comprises an air knife.

26. The apparatus for treating material of claim 24, wherein any fluid communication between second region and the first region is via the conduit.

27. The apparatus for treating material of claim 1, wherein the second region includes a flow of filtered fluid filtered through a HEPA filtration system.

28. The apparatus for treating material of claim 27, wherein the flow of filtered fluid is included in the flow of fluid in the fluid flow region.

29. The apparatus for treating material of claim 1, wherein the second region comprises any one of a Restricted Access Barrier System (RABS), a cleanroom isolator, or a glovebox.

30. The apparatus for treating material of claim 1, further comprising: at least one additional system disposed along the material pathway, the at least one additional system including any of a particulate removal system, a vibrational treatment system, an inspection system, a marking system, or a repair system.

31. The apparatus for treating material of claim 1, further comprising: an inspection system configured to inspect the portion of the material after treatment of the portion of the material by determining whether the portion of the material satisfies a quality condition.

32. The apparatus for treating material of claim 31, the inspection system comprising: an electromagnetic radiation (EMR) detector configured to detect a flaw in the portion of the material, a foreign substance on the portion of the material, or a pathogen on the portion of the material.

33. The apparatus for treating material of claim 32, wherein the EMR detector detects at least one of ultraviolet radiation, infrared radiation, visible light, or X-Radiation.

34. The apparatus for treating material of claim 32, further comprising: an EMR emitter configured to emit EMR detectable by the EMR detector towards the portion of the material.

35. The apparatus for treating material of claim 31, the inspection system comprising: a marking system configured to mark a defective portion of portion of the material based on the inspection of the inspection system.

36. The apparatus for treating material of claim 35, wherein the marking system includes an embossing system, a gravure system, an etching system, or a sterile lithography system.

37. The apparatus for treating material of claim 31, further comprising: a repair system configured to repair defects in the portion of the material detected by the inspection system.

38. The apparatus for treating material of claim 37, wherein the repair system includes a surface heater, a heating fluid source, or an infrared radiation source.

39. The apparatus for treating material of claim 1, further comprising a repair system configured to repair defects in the material resulting from a treatment of the material.

40. The apparatus for treating material of claim 1, wherein the treatment substance includes carbon dioxide, argon, water, nitrogen, or a combination thereof.

41. The apparatus for treating material of claim 1, wherein the treatment substance is configured to treat the portion of the material by the expulsion of a substance by at least one of removing particulates from, depyrogenation of, or sterilization of the portion of the material.

42. The apparatus for treating material of claim 1, wherein the second region is aseptic and the first region is not aseptic.

43. The apparatus for treating material of claim 1, wherein the treatment system is configured to provide the treatment substance in a laminar flow on the portion of the material.

44. The apparatus for treating material of claim 1, wherein the portion of the material is oriented at least partially vertically and wherein the treatment system expels the treatment substance at the portion of the material in an at least partially downward, upstream direction.

45. The apparatus for treating material of claim 1, wherein the material includes a removable layer, and the treatment system is configured to expel the treatment substance to at least partially remove the removable layer from the portion of the material.

46. A method for treating material, the method comprising: transiting a material along a material pathway from a first region to a second region, the material pathway extending through a fluid flow region between the first region and the second region, wherein the fluid flow region includes a flow of fluid across the material; treating the material by expulsion of a treatment substance onto a portion of the material prior to the portion of the material transiting to the second region; and transiting the material into the second region while maintaining the second region at a state of cleanliness such that a treated condition of the material is maintained as the material transits into the second region.

47. The method for treating material of claim 46, including maintaining the first region at a first state of cleanliness, the state of cleanliness of the second region being a relatively cleaner state of cleanliness.

48. The method for treating material of claim 46, wherein treating the material by expulsion of a treatment substance onto a portion of the material occurs prior to transiting the material along the material pathway through the fluid flow region.

49. The method for treating material of claim 46, including maintaining the fluid flow region at substantially a same state of cleanliness as the second region.

50. The method for treating material of claim 46, wherein the material includes a sheet of material that is flexible and substantially planar.

51. The method for treating material of claim 50, wherein the material includes a formed section.

52. The method for treating material of claim 46, wherein the fluid flow region includes a flow of fluid directed across a downstream section of the material towards an upstream section of the material.

53. The method for treating material of claim 46, wherein the flow of fluid is directed from the second region to the first region.

54. The method for treating material of claim 46, wherein the treatment substance includes carbon dioxide, and the expulsion of the treatment substance forms a jet including solid or liquid carbon dioxide particles.

55. The method for treating material of claim 54, wherein the jet removes particulates from a portion of the material.

56. The method for treating material of claim 55, including treating the particulates removed from the portion of the material by the jet.

57. The method for treating material of claim 56, including treating the particulates removed from the portion of the material by any of ultraviolet radiation, a gamma irradiation, other EMR, a heating, an incineration, or a sterilizing fluid application.

58. The method for treating material of claim 50, further comprising: providing, by a source reel of a reel system, the sheet of material to the first region prior to the transiting.

59. The method for treating material of claim 58, further comprising: receiving, by a downstream reel of the reel system, sheet of material after the treating, the downstream reel positioned in the second region.

60. The method for treating material of claim 50, wherein the sheet of material includes a polymer layer.

61. The method for treating material of claim 50, wherein the treating comprises: expelling the treatment substance onto an entire transverse width of the portion of the material.

62. The method for treating material of claim 50, wherein the treating comprises: expelling the treatment substance onto an entire transverse width of each of a first surface of the portion of the material and a second surface of the portion of the material on an opposite side of the sheet of material form the first surface.

63. The method for treating material of claim 46, wherein the treating is conducted by a treatment system, including at least one nozzle and a substance source configured to provide the treatment substance to the at least one nozzle for the expulsion.

64. The method for treating material of claim 63, wherein the treatment substance includes a pressurized fluid at a first pressure higher than a second pressure of an environment of the fluid flow region in which the portion of the material receives the treatment substance from the expulsion, the expulsion based on the first pressure and the second pressure.

65. The method for treating material of claim 64, wherein a difference between the first pressure and the second pressure at least partially transitions the treatment substance from a fluid state to a solid state during the treating.

66. The method for treating material of claim 64, wherein the second pressure is at or below atmospheric pressure.

67. The method for treating material of claim 63, the treating comprising: directing the at least one nozzle to direct the treatment substance at the portion of the material in an upstream direction.

68. The method for treating material of claim 63, wherein the portion of material includes a sheet of material, the at least one nozzle comprising a first nozzle and a second nozzle, the treating comprising: directing a first nozzle at a first side of the sheet of material; and directing a second nozzle at a second side of the sheet of material opposite the first side.

69. The method for treating material of claim 63, further comprising: modifying an orientation of the at least one nozzle relative to the portion of the material.

70. The method for treating material of claim 46, the fluid flow region further comprising a conduit, the treating comprising: flowing the flow of fluid through the conduit; and expelling the treatment substance onto the portion of the material within the conduit.

71. The method for treating material of claim 70, including producing the flow of fluid using an air knife.

72. The method for treating material of claim 70, wherein any fluid communication between second region and the first region is via the conduit.

73. The method for treating material of claim 46, including flowing a filtered fluid filtered by HEPA filtration through the second region.

74. The method for treating material of claim 73, including flowing the filtered fluid with the flow of fluid through the fluid flow region.

75. The method for treating material of claim 46, further comprising: treating the material at least a second time when the material is in transit along the material pathway by any of: removing particulates from a material surface of the material by adhesion to a contacting surface; vibrating the material surface and removing vibrationally de-adhered particulates with negative pressure; inspecting a surface of the material and marking a portion of the material when an inspected characteristic meets a certain value or range; or repairing a surface of a material using a heat treatment.

76. The method for treating material of claim 46, further comprising: inspecting, by an inspection system, the portion of the material after the treating by determining whether the portion of the material satisfies a quality condition.

77. The method for treating material of claim 76, further comprising: detecting, by an electromagnetic radiation (EMR) detector, a flaw in the portion of the material, a foreign substance on the portion of the material, or a pathogen on the portion of the material.

78. The method for treating material of claim 77, wherein the EMR detector detects at least one of ultraviolet radiation, infrared radiation, visible light, or X-Radiation.

79. The method for treating material of claim 77, further comprising: emitting, by an EMR emitter, EMR detectable by the EMR detector towards the portion of the material.

80. The method for treating material of claim 76, further comprising: marking a defective portion of portion of the material based on the inspecting by the inspection system.

81. The method for treating material of claim 80, wherein the marking includes embossing, providing a gravure, etching, or sterile lithography of the defective portion.

82. The method for treating material of claim 46, further comprising: repairing defects in a portion of the material after treating the portion of the material.

83. The method for treating material of claim 82, wherein the repairing includes modifying the defective portion by a surface heater, a heating fluid source, or an infrared radiation source.

84. The method for treating material of claim 46, further comprising: neutralizing removed elements removed from the portion of the material by the expulsion to satisfy a safety standard.

85. The method for treating material of claim 84, wherein the neutralizing includes applying ultraviolet radiation, gamma radiation, a different EMR, heat, an incinerator, or a sterilizing fluid to the removed elements.

86. The method for treating material of claim 46, wherein the treatment substance includes carbon dioxide, argon, water, nitrogen, or a combination thereof.

87. The method for treating material of claim 46, wherein the expulsion at least one of removes particulates from, depyrogenates, or sterilizes the portion of the material.

88. The method for treating material of claim 46, wherein the second region is aseptic and the first region is not aseptic.

89. The method for treating material of claim 46, wherein the flow of fluid is provided in a laminar flow over the portion of the material.

90. The method for treating material of claim 46, further comprising: washing the portion of the material with a surfactant, sterilized water, or ionized air.

91. The method for treating material of claim 46, the transiting comprising vertically orienting the portion of the material, and the treating comprising expelling the treatment substance at the portion of the material in an at least partially downward direction.

92. The method for treating material of claim 46, wherein the material includes a removable layer, the expulsion including expelling the treatment substance to at least partially remove the removable layer from the portion of the material.