US20040154269A1 - System, device and method for the manufacture and handling of a substantially pure object - Google Patents

System, device and method for the manufacture and handling of a substantially pure object Download PDF

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Publication number
US20040154269A1
US20040154269A1 US10/717,209 US71720903A US2004154269A1 US 20040154269 A1 US20040154269 A1 US 20040154269A1 US 71720903 A US71720903 A US 71720903A US 2004154269 A1 US2004154269 A1 US 2004154269A1
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United States
Prior art keywords
fluid
mold
syringe
air
handling
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Abandoned
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US10/717,209
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English (en)
Inventor
Jochen Heinz
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Transcoject Gesellschaft fur medizinische Gerate mbH and Co KG
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Transcoject Gesellschaft fur medizinische Gerate mbH and Co KG
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Assigned to TRANSCOJECT GESELLSCHAFT FUR MEDIZINISCHE GERATE MBH & CO. KG reassignment TRANSCOJECT GESELLSCHAFT FUR MEDIZINISCHE GERATE MBH & CO. KG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HEINZ, JOCHEN
Publication of US20040154269A1 publication Critical patent/US20040154269A1/en
Priority to US11/209,312 priority Critical patent/US7584591B2/en
Priority to US12/501,154 priority patent/US8308472B2/en
Abandoned legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/02—Machines characterised by the incorporation of means for making the containers or receptacles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/202—Ozone
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/1701—Component parts, details or accessories; Auxiliary operations using a particular environment during moulding, e.g. moisture-free or dust-free

Definitions

  • the invention concerns a procedure for the manufacture and/or handling of a substantially pure object, in particular a medical container, for example, a prefillable container for the reception of drugs. Furthermore, the invention concerns a corresponding device for the handling of such a substantially pure object.
  • prefillable containers such as, for example, prefillable bottles or prefillable syringes made from glass or plastic, which are delivered, prefilled with a drug.
  • contamination of a plastic article may occur when following the manufacturing and ejection process, the plastic article exhibits an electrostatic charge, which attracts particles from the environment and prevents the attached particles from being rinsed off. Therefore, in the customary manufacturing process a procedure is used in order to discharge the plastic parts after ejection. At the same time, however, the discharging is often incomplete and recharging effects occur, through which charges from the inside of the plastic parts reach the surfaces over a longer period of time.
  • U.S. Pat. No. 5,620,425 describes the manufacture of a prefillable syringe cylinder in a Class 100 clean room, which ought to prevent impurities during the manufacture of the syringe body.
  • a Class 100 clean room atmosphere is only possible with the creation of a laminar flow, which can only be maintained with a high level of difficulty, especially when personnel are working in the clean room and an injection molding machine, requiring the opening and closing of mold platens, is used. Therefore the conditions described in U.S. Pat. No.
  • U.S. Pat. Nos. 6,164,044, 6,189,292, 6,263,641 and 6,250,052 describe a further manufacturing procedure for the manufacture of prefillable glass or plastic containers.
  • the containers or the syringe cylinders are put into a closed system following their production by the pouring or forming of the glass or the injection molding of the plastics for further processing.
  • This system consists of individual containers or cabinets in which a clean room atmosphere prevails.
  • the containers manufactured outside of this clean room atmosphere are brought into the closed system they are first cleaned by a current of purified air so that any particles or germs potentially attached to the containers are rinsed off or sprayed away from the containers.
  • the containers cleaned in this way are subsequently further processed in the system in which Class 100 clean room conditions prevail.
  • the system, device and/or method of the present invention are directed, in a preferred embodiment, to the manufacture and/or handling of a substantially pure object.
  • a substantially pure object for example, may be a medical object, such as a medical container or syringe, which has to be substantially pure, that is to say essentially or substantially free from microbes and particles.
  • the present invention in a preferred embodiment, provides a method for molding a component of a medical container that is substantially pure, without the need for subsequent air or water washing and/or the strict conditions of Class 100 clean rooms.
  • the substantially pure object is protected from the environment during a handling process by a fluid that envelops or surrounds the object.
  • those parts or components of an object that have to exhibit the required purity are enveloped by the flowing fluid during critical steps of the manufacturing and/or handling process, and are therefore maintained in a defined protective atmosphere.
  • an initially substantially pure object is not contaminated through contact with the environment during handling and further processing.
  • the present invention may provide a manufactured object of greater purity than with current techniques because contamination of the object can be prevented from the outset, instead of being removed again in later purification, cleaning or washing steps, when a complete removal of impurities during the cleaning process is, for the most part, not possible.
  • the present invention provides a protective atmosphere for an object to prevent contaminants from contacting or adhering thereto in the first place, thereby avoiding the need for air or water washing.
  • the protective atmosphere may be provided at lower fluid flow rates and fluid quantities than is required for standard air or water washing techniques, which reduces the complexity and cost of the process.
  • the present invention eliminates production steps required in known manufacturing processes, which not only shortens the entire manufacturing procedure, increases its efficiency and reduces its costs, but also reduces the risk of the object being contaminated during the process.
  • the transfer steps between different environments can be avoided.
  • the object always remains in the environment generated by the circulating fluid.
  • steps subsequent to removal of the object from the molding machine the object may be handled and/or processed in another environment, such as a Class 1000 or a Class 10,000 environment. Examples of steps subsequent to object removal may include, but are not limited to, siliconization, inspection and packaging steps.
  • the object is a matter of a thermo-formed object in a mold where the object is protected from the environment during the entire removal process from the mold by the enveloping fluid.
  • the object is, for example, an object made from metal or plastic, which has been manufactured in an injection process, for example, an injection molding or a die-casting in the mold.
  • the invention exploits the effect that a thermo-formed object, for example, an object made from liquid plastic, exhibits perfect purity after it sets. This especially applies with regard to particles and, due to melting temperatures up to more than 300° Celsius, endotoxins.
  • the object By enveloping the freshly molded object during its removal from the mold, the object, which is pure because of the manufacturing process, is prevented from subsequently being contaminated. Due to the fluid envelope or the fluid sheathing, the object does not contact and is therefore not contaminated by the ambient air, which prevents the object from being contaminated from the outset.
  • This has the advantage that no especially pure environmental conditions have to be achieved so, for example, the expensive and costly Class 100 clean rooms can be done away with during the manufacture of medical objects or containers.
  • the present invention prevents object contamination from the outset, cleaning or rinsing of the object prior to further processing, as is required with current technology, is avoided.
  • the substantially pure object, which is protected from contamination by the enveloping fluid may be passed on directly for further processing without an intermediate step. In this way, a very cost effective and efficient manufacturing process can be achieved.
  • the system, device and/or procedure of the present invention are preferably suitable for the manufacture of an object that is or is a component part of a medical container.
  • This type of container may be, for example, a prefillable bottle or a prefillable syringe made from a suitable plastic, in particular a barrier plastic, which is formed in the mold.
  • the forming of the container part or of the container is preferably done in an injection molding or an injection blow molding procedure.
  • all parts or components of a medical container in particular those parts that contact a drug or pharmaceutical, may be manufactured and handled without becoming contaminated in connection with the molding process.
  • the present invention preferably renders a subsequent fluid washing or cleaning step unnecessary.
  • the original purity or the sterility at the time of removal from the mold is maintained up until filling without the handling process having to be run in a special Class 100 clean room.
  • the fluid with which the object is enveloped may be a liquid or a gas.
  • the fluid is a gas and, in particular, air or filtered air.
  • the required freedom of the gas or of the air from microbes and particles can be guaranteed through proper filtration.
  • Preferably, 0.2 ⁇ m filters or filters with even smaller pore diameters are used to guarantee the required purity of the air.
  • the air or the filtered air envelops the object as completely as possible so that an envelope of air is created, which protects the object that is clean from potentially contaminated ambient air as a result of the progressing manufacturing process.
  • the fluid is conditioned air, for example, moistened air, to prevent static loads from building on the object, or to compensate for static loads on the object.
  • Static charging of the objects is avoided through the direct use of the conditioned air at the time of removal of the object from the mold, so that particulates or microbes may be prevented from attaching to the object due to static charges on the object.
  • the cavity in the container component or part i.e., resulting from the removal of the core
  • the cavity in the container component or part is aerated immediately with the enveloping gas, in particular the filtered and/or conditioned air, at the time the component or part is removed from the mold.
  • the fluid is deionized air and, most preferably, filtered, conditioned and deionized air.
  • the object to be handled only comes into contact with the air prepared in this way and, if necessary, a static charge originating at the time of the removal process resulting through the friction may be in statu nascendi, that is to say, immediately compensated for when it occurs. It is also possible, since no more charges are occurring, to no longer do this inside of a plastic matrix, which reacts together with the additional charge effects described below, as they occur in the known procedures.
  • the envelopment of the object has the effect that the object is in contact with the fluid or the gas or the processed air for a very long time.
  • the present invention requires relatively low discharge rates and recharging effects, as they occur in the current state of technology, are compensated for or reduced.
  • the charge of the object may also be measured and the flow of deionized air can be controlled or regulated so that the charge occurring in the object can be precisely compensated for without resulting in a renewed undesired charge.
  • the grippers holding the object may be grounded so that charges are dissipated.
  • the fluid by which the object is enveloped may also preferably contain, at least as a component, a sterilizing fluid or gas.
  • a sterilizing fluid or gas for example a gas containing H 2 O 2 , ozone or something similar, may be used as a sterilizing gas.
  • purified air, CO 2 , noble gases or other gases may be used for enveloping or sheathing the object, in particular at the time of removal from the mold.
  • the present invention contemplates the use of any and all suitable gases that create a substantially pure atmosphere in the immediate environment of the object to prevent contamination by the environmental air.
  • the envelopment of the object functionally starts when the object is still in the mold. More preferably, the envelopment or the sheathing of the object starts immediately after the mold is opened so that the object manufactured in this way does not contact the environmental or ambient air. In this way, contamination of the sterile or cleanly manufactured object can be securely prevented when the mold is opened and/or the object is removed therefrom, as well as during further processing.
  • the removal of the object from the mold is done in a defined way by machine.
  • the object can be removed in a predefined way and at a predetermined speed.
  • a desired removal speed is always maintained at which it is guaranteed that the envelope made by the circulating fluid or gas neither drifts away nor is degraded or damaged.
  • the fluid environment or sheathing is preferably maintained during removal (from the mold) and movement of the object.
  • the static charge at the time of removal of the object from the mold can also be minimized through the defined movement.
  • the course and motion of the object's removal with respect to the mold can be controlled in such a way that hardly any particles are formed during removal of the object, for example, due to friction between the mold and the object.
  • the defined removal by machine from the mold may, for example, be done by a robotic arm or by another suitable handling device, which can be operated with predetermined speeds and accelerations.
  • the object is removed from the mold using a robot and is simultaneously separated or ejected from the mold by an ejector mounted in the mold.
  • This makes it possible to remove an object, especially a plastic object, from the mold while it is still in a relatively soft or semi-molten state.
  • the ejector and the robot that grips the object the required removal or separation strength is applied to several places on the object to remove the object from the mold.
  • the material of the object only has to support low forces at the time of removal. In this way, isolated acting high forces, which could lead to deformations of an object that is still soft or semi-molten, are avoided.
  • the removal of the object from the mold is done with a low starting speed. That means that the object is first detached from the mold with the lowest possible speed.
  • the speed of motion can subsequently be increased a step at a time or progressively increased in order to make fast handling possible.
  • a clean separation of the object from the surface of the mold can be achieved without any particles remaining attached to the surface of the object due to deformations. Potential contamination of the object during removal from the mold is further minimized in this way.
  • the removal of the object from the mold is preferably done before total cooling of the object.
  • the removal of the object is done at the highest removal temperature possible, which results in the object or component thereof being in a relatively soft state at the time of removal.
  • the defined removal by machine is also an advantage here since only a machine removal makes a removal without deformities possible when the plastic is still soft compared with an exclusively mold linked deformation of the plastic object.
  • the plastic that is still soft makes a clean detachment from the surface of the tool possible without the occurrence of undesired particles because the surface of the plastic on a microscopic level exhibits a certain degree of plasticity. Furthermore, static charges due to friction may be minimized.
  • the fluid circulating around the object at the time of removal also operates to cool the object.
  • the removal of the object from the mold is conducted, in a preferred embodiment, using a robot having at least one nozzle connected to a fluid source for enveloping the object with a fluid.
  • the nozzle or nozzles are preferably arranged as closely as possible on a gripping device of the robotic arm that grips the object.
  • the object is preferably enveloped or sheathed by the fluid from the ambient air.
  • the object is enveloped as thinly as possible to keep the extent of the atmosphere created by the fluid or the gas, and therefore the quantities of fluid, as low as possible, while still providing the benefits of the present invention.
  • nozzles may be configured in at least one part of the mold to envelop the object with the fluid.
  • the object may already be enveloped in the mold with fluid immediately at the time the mold is opened, so that the object does not contact the ambient air through the entire removal process from the mold.
  • the fluid nozzles may be configured in the moving and/or the stationary part of the mold. The precise configuration depends on the geometry of the mold and on the component to be generated. The nozzles are configured in such a way that, at the time of removal, the object or component is enveloped with fluid or gas, in particular with high purity air, in order to prevent impurities from attaching or adhering to the object.
  • the mold preferably exhibits a surface, which is treated in such a way that it exhibits a minimal contact power. This also contributes to there being no undesired particles occurring at the time of removal, which could potentially attach to the surface of the object. So from the outset a sufficiently clean object is created which does not require any subsequent cleaning, since in compliance with a preferred embodiment of the invention it is shielded from the ambient air by an enveloping fluid.
  • the surface of the mold is preferably designed with a surface roughness that is neither too small nor too large in order to achieve the least possible bond between the object and the mold.
  • the surface of the mold may be coated with suitable materials such as Teflon or titanium nitride. All other suitable coatings or procedures for the treatment of mold surfaces may also be used in order to realize a minimum attachment between the object created and the mold.
  • the object may also be surrounded by a protective bell immediately upon removal from the mold in addition to envelopment with the fluid.
  • a protective bell is at least a single sided, open hollow part so that the object can get into the bell through the opening.
  • the bell may be made, for example, from plastic or metal and is preferably fixed to a robotic arm, which removes the object from the mold and handles it further.
  • the fluid flowing around the object, in particular a gas is preferably conducted in such a way that it completely fills the bell so that no potentially contaminated ambient air gets into the bell.
  • the bell has the advantage that drifting of the fluid or gas layer that is enveloping the object is prevented, even when the movement of the container part by the robotic arm is fast.
  • the bell of the present invention provides an adequate shield from the environmental air when the object is being moved.
  • an automatic or a semi-automatic subsequent treatment follows at the time of removal of the object from the mold.
  • This may include one or several subsequent processing steps, such as, for example in the case of a medical container or a part of a container, siliconization, inspection, assembly, labeling, filling and packaging steps.
  • These further processing may be done in a closed plant (e.g., in a separate facility or in the same facility in which the molding step was completed) in which sufficient conditions, such as Class 10,000 conditions, prevail, such as is known, for example from U.S. Pat. No. 6,189,292, U.S. Pat. No. 6,263,641, U.S. Pat. No. 6,250,052 and U.S. Pat. No. 6,164,044.
  • a greater freedom is permitted in the subsequent process steps because the objects or parts molded according to a preferred embodiment of the present invention are substantially pure prior to being passed on to further processing, and therefore the overall contaminant load for the objects are barely approached after the molding step. This outcome can be contrasted with current processes, from which the molding step typically contributes a substantial portion of contaminant load for the entire process.
  • the shielding of the object removed from the mold by the enveloping fluid is also maintained during one or more of the subsequent handling and/or processing steps. It is also possible to do away with the Class 100 clean room during these subsequent handling and/or processing steps since the object, preferably a part of a container, is protected from the environmental air through the shielding or the envelopment of the object.
  • this fluid envelope in particular an envelope made out of substantially pure air, corresponding air nozzles are conveyed along with the product or with the container part.
  • the required nozzles are configured directly on the robotic arm that moves the object.
  • the envelopment of the object removed from the mold with the fluid may be used to quickly cool off the container part.
  • a targeted fast cooling of the object may be desired in the case of partial crystalline plastics or for the prevention of crystallization.
  • An appropriately fast and defined cooling can be achieved through the appropriate tempering of the fluids with which the object is being enveloped.
  • the envelopment of the object removed from the mold can be used for a slow cool down. This may be desirable, for example, for the removal or prevention of cooling stresses in amorphic plastics.
  • the fluid used may be appropriately tempered to achieve a targeted slow cooling of the object. Through the appropriate tempering and control of the volume flow of the fluid, the cooling speed of the object removed from the mold can be adjusted across a wide range depending on the type of the plastic or of the material used.
  • the object is preferably fitted together or assembled with other components, either in the same facility or separate facilities. Both the object as well as the other components, if required, can be protected from contaminants from the environmental air through a fluid environment or sheathing, as described above.
  • the object may be a container, for example, a medical container, which is to be fitted together with other components and/or filled and closed.
  • a container to be fitted together may be removed from a mold and handled in the previously described way.
  • barrels, plungers and/or tip caps of a syringe to be prefilled may be appropriately handled so that all of the parts of the container or of a prefillable syringe coming in contact with a drug during the entire production or handling process are protected from environmental impurities.
  • At least individual procedural steps may take place in a Class 1000, 10,000 or 100,0000 controlled environment or at a lower purity.
  • a Class 100 clean room environment such as is required by the current state of technology, is not necessary in compliance with the invention since the object to be handled or, more precisely, the container part to be handled, is shielded from contaminants by the enveloping fluid.
  • the more pure clean room classifications e.g., Class 10 or 100
  • a siliconization of the object takes places immediately following removal of the object from the mold.
  • Such a siliconization is, for example, required for the manufacture of prefillable medical containers.
  • a siliconization step conducted immediately after removal of the object from the mold, when the object is preferably not quite totally cooled down, has the advantage that the surface of the object is already activated. So no additional activation prior to siliconization is required for plastic objects, as a result of which the manufacturing procedure is further simplified and accelerated.
  • a visual inspection with the naked eye or one done automatically with a camera, can be carried out where the flawless state of the object as well as the quality of the siliconization are able to be checked simultaneously.
  • the fluid enveloping the object can also be used to influence the surface characteristics of the object.
  • the fluid, and in particular the gas can be selected in such a way that predetermined reactions with the surface layer of the object are entered into in order to achieve certain surface characteristics.
  • corresponding auxiliary agents can be mixed with the fluid.
  • auxiliary agents and reactants can be removed again through the fluid flow.
  • a special preference is to use the fluid enveloping the object to harden and/or dry a surface coating.
  • the surface coating may, for example, be silicon, which is applied during a siliconization step.
  • the enveloping gas which protects the object from environmental influences, may be used to accelerate the drying or the hardening of the silicon.
  • the invention also concerns a device for the handling of a substantially pure object, in particular a medical object such as a medical container or part of a container.
  • the handling device includes at least one nozzle for the discharging of a fluid.
  • the nozzle for the discharging of the fluid is configured in such a way that the fluid envelops an object being held in the handling device. Consequently, at least one nozzle is configured in such a way that the fluid flows over those parts of the object which are to be protected from the environmental air so that the fluid can form a protective layer or a protective envelope around the object.
  • the precise configuration and number of the nozzles used depends on the shape of the object to be protected.
  • the handling device is a robotic arm with a gripping device to secure the object.
  • At least one nozzle is configured close to the gripping device.
  • the object can be as directly as possible in the flow so that the casing formed by the fluid flow is placed as closely as possible to the object.
  • the amount of the fluid required is reduced and a closely defined atmosphere surrounding the object is created, for example, from a substantially pure gas.
  • a protective shield configured on the handling device, which at least partially covers the fluid being discharged.
  • a protective shield serves to prevent a distortion or a displacement of the fluid when the handling device is moved. Therefore, the protective shield is preferably configured at least in the path of the motion in front of the fluid casing and in front of the object lying in the casing.
  • the protective shield takes the form of a bell that sheathes not only the object but also the fluid surrounding the object, so that the fluid casing protecting the object can be maintained when the handling device is moved quickly.
  • FIG. 1 shows a perspective view of a preferred initial step in a molding operation of the present invention
  • FIG. 2 shows a perspective view of a preferred second step in a molding operation of the present invention
  • FIG. 3 shows a perspective view of a preferred third step in a molding operation of the present invention
  • FIG. 4 shows a horizontal projection of a first preferred embodiment for enveloping an object, such as a medical syringe, in a protective fluid;
  • FIG. 5 shows a perspective view of the preferred embodiment shown in FIG. 4;
  • FIG. 6 shows a horizontal projection of a further preferred embodiment for enveloping an object in a protective fluid
  • FIG. 7 shows a perspective view of the further preferred embodiment shown in FIG. 6;
  • FIG. 8 shows a sectional view and a horizontal projection of yet another preferred embodiment for enveloping an object in a protective fluid
  • FIG. 9 shows a partially cropped perspective view of the preferred embodiment shown in FIG. 8.
  • FIG. 10 shows an elevational view, partially in cross-section, of still another preferred embodiment for enveloping an object in a protective fluid
  • FIG. 11 shows a perspective view of the preferred embodiment shown in FIG. 10;
  • FIG. 12 shows a horizontal projection of an alternate embodiment for enveloping an object in a protective fluid
  • FIG. 13 shows a perspective view of the alternate embodiment shown in FIG. 12;
  • FIG. 14 shows a perspective view of a preferred embodiment of the present invention for manufacturing and processing a substantially pure object
  • FIG. 15 shows a perspective view of an alternate embodiment of the present invention for manufacturing and processing a substantially pure object
  • FIG. 16 is a flowchart of a manufacturing process performed in conjunction with a preferred embodiment of the present invention.
  • FIG. 17 is a diagram showing the layout of a manufacturing line used in conjunction with a preferred embodiment of the present invention.
  • FIG. 18 is a perspective view of a preferred embodiment of a mold and a robotic machine of the present invention.
  • FIG. 19 is a perspective view of the preferred embodiment of the robotic arm and handling device shown in FIG. 18;
  • FIG. 20 is an enlarged, perspective view of the handling device shown in FIGS. 18 and 19;
  • FIG. 21 is a cross-sectional view of the handling device shown in FIGS. 18 - 20 , with a syringe barrel being held therewithin.
  • the present invention is described below in terms of molding and/or processing a medical syringe. However, it is contemplated that the systems, devices and methods of the present invention can be used, implemented with or incorporated into the molding, manufacture, processing and/or handling of any object that needs to be produced and/or maintained in a pure or substantially pure condition.
  • FIG. 1 shows an initial procedural step in which both halves of the mold 2 and 4 are opened.
  • the container part made in the mold 2 , 4 in the form of a plastic syringe 6 is still on a mandrel on the mold 2 .
  • jets 8 configured in a ring surrounding the mandrel on the mold 2 , through which gas, preferably deionized and conditioned substantially pure air, flows out in the direction of the arrows shown in FIG. 1.
  • the discharge of the air preferably starts with the opening of the mold halves 2 and 4 .
  • the direction of the flow goes in such a way that the air flows as linearly as possible along the lengthwise direction on the outside of the syringe 6 .
  • the container part that is to say the syringe 6
  • a protective shell made from substantially pure air, which flows out of the jets 8 .
  • this procedure works with deionized air that discharges any static charges in the syringe 6 potentially created when the mold halves 2 and 4 are opened. In this way it is possible to prevent particles from settling down on the surfaces of the syringe as a result of these static charges.
  • FIG. 1 Furthermore a robotic arm 10 is shown in FIG. 1, on which is fixed a gripping device 12 for the removal of the syringe 6 from the mold half 2 .
  • the gripping device 12 initially consists of a cylindrical bell 14 , which defines an opening 16 on its face, through which the syringe 6 can be taken in.
  • In the area of the foremost end of the bell 14 i.e., the ends turned towards the opening 16 ), there are two grippers 18 , 20 to hold the syringe 6 configured facing each other.
  • the grippers 18 and 20 are able to be moved using actuating drives 22 , 24 lengthwise in the direction of arrow A in order to grip the syringe 6 .
  • the actuating drives 22 and 24 may, for example, be actuated hydraulically, pneumatically or electrically.
  • the bell 14 On its rearmost end, the bell 14 exhibits a gas entry opening or a nozzle 26 , which is connected with an air supply device.
  • Preferably substantially pure, deionized and conditioned air is conducted through the line 28 , the gas entry opening or nozzle 26 in the direction of the arrow in FIG. 1, and into the inside of the bell 14 .
  • the air flows in parallel to the lengthwise direction of the bell 14 to the opening 16 and exits through this opening into the open air.
  • the robotic arm 10 is first moved in the direction of arrow B until the opening 16 of the bell 14 is positioned opposite the syringe 6 . Subsequently the robotic arm 10 is moved in the direction of arrow C so that the bell 14 and the grippers 16 and 18 are pulled over the syringe 6 , as is shown in FIG. 2. The bell is moved in the direction of arrow C in FIG. 1 to the point that it completely encloses the syringe 6 . At the same time the syringe 6 finds itself between the grippers 18 and 20 . The grippers 18 and 20 are moved by the actuating drives 22 , 24 in the direction of arrow A in FIG.
  • substantially pure, deionized and conditioned air flows in continually through the gas entry opening 26 in the bell 14 and flows inside of the bell along the outside of the syringe 6 and subsequently exits through the opening 16 on the bell 14 to the open air.
  • the flow of gas through the jet 8 in the mold 2 can be switched off because the syringe 6 in this position is completely enveloped by the gas or the airflow in the bell 14 .
  • the air flow in the bell 14 has the effect that the syringe 6 is totally protected from the environmental air and in this way is shielded from contaminants from the environmental air.
  • the robotic arm is moved away in the direction of arrow D in FIG. 3.
  • the appropriate mold ejector may, if necessary, support this movement so that the isolated force working on the syringe can remain low. This allows for removal to take place at relatively high temperatures. In individual cases, however, it is possible to do away with the grippers 18 , 20 as well as the ejector.
  • the syringe 6 which is held in the bell 14 by the grippers 18 , 20 , is peeled off a mandrel of the mold halves 2 .
  • the airflow in the bell 14 is continued as is shown by the arrow in FIG. 3.
  • the volume resulting from the pulling out of the syringe is filled with purified and conditioned air so that primarily the inside of the syringe stays clean and a potential charge is neutralized at its origin.
  • the bell 14 protects against the air flow drifting and against the protective casing formed by the air flow around the syringe 6 being distorted. In this way the syringe 6 can be reliably protected from contaminants when it is being moved or removed from the mold 2 , 4 .
  • the robotic arm 10 executes a movement in the direction of arrow E in FIG. 3, through which the syringe 6 is taken out of the space between the mold halves 2 and 4 .
  • the syringe 6 may be conveyed by the robotic arm 10 to further processing steps where the syringe is, for example, siliconized, inspected, assembled, filled, packaged, etc.
  • the syringe preferably remains in the robotic arm and/or the syringe 6 is, preferably by the appropriate nozzles, surrounded with substantially pure air in order to prevent contaminants from contacting the syringe.
  • the bell 14 on the robotic arm can be done away with.
  • the grippers 18 , 20 as well as the actuating drives 22 , 24 may be configured directly on the robotic arm 10 .
  • There are corresponding air nozzles on the robotic arm 10 which are configured in such a way that one of the grippers 18 , 20 holding the component part, for example a syringe, can be completely surrounded with gas without the bell 14 in order for it to be protected from contaminants.
  • FIGS. 4 and 5 an initial arrangement is shown for the envelopment of a substantially pure object, such as a syringe 6 . Even if the example is based on the handling of a syringe 6 , other substantially pure components can certainly also be handled in the same way.
  • a horizontal projection is to be seen in FIG. 4 and a perspective view of the arrangement is to be seen in FIG. 5.
  • the arrangement consists of two pipes 30 which each exhibits a large number of nozzles 32 . In the example shown the pipes 30 extend in parallel to one another and in parallel with the longitudinal axis of the syringe 6 .
  • a row of nozzles 32 is arranged over the entire length of the pipes, through which a fluid or a gas is discharged in order to enclose the syringe 6 and by doing so to protect it from the environment.
  • the pipes 30 are connected with a system of pipelines 34 through which the fluid, in particular a gas, for example substantially pure air, is lead into the pipes 30 .
  • the flow of fluid is indicated by arrows in FIGS. 4 and 5.
  • the nozzles 32 are arranged in such a way that the flow is directed at the syringe 6 from two sides fundamentally in a 90° angle to one another so that the syringe can be completely enveloped by the fluid from all sides and the syringe 6 is shielded by the fluid and protected from the environmental air.
  • FIGS. 6 and 7 show a variation of the arrangement shown in FIGS. 4 and 5.
  • the arrangement shown in FIGS. 4 and 5 there are three pipes provided in the arrangement, which pipes simultaneously distribute fluid around the perimeter of the syringe 6 to be protected so that the syringe 6 is enveloped with fluid from all sides, as is indicated by arrows in FIGS. 6 and 7.
  • the arrangement of the pipes 30 corresponds with the arrangement described in FIGS. 4 and 5.
  • the three pipes 30 are connected with a piping system 34 to supply the fluid or the gas, where the flow of the fluid in the piping system is shown in FIGS. 6 and 7 using arrows.
  • FIGS. 8 and 9 show a further arrangement for the envelopment of a substantially pure object, such as a syringe 6 , with a fluid, for example, a gas such as substantially pure air.
  • a substantially pure object such as a syringe 6
  • a fluid for example, a gas such as substantially pure air.
  • FIGS. 8 and 9 the syringe 6 is surrounded by a bell 14 .
  • FIG. 8 shows a horizontal projection and a sectional view of this arrangement
  • FIG. 9 shows a partially cropped perspective view.
  • the bell is formed cylindrically and has an opening 16 on one side through which the syringe 6 may be inserted into the bell 14 or the bell 14 may be pulled over the syringe 6 .
  • the bell 14 is closed on the opposite back side and exhibits a gas entry opening or a nozzle 26 , which is connected with piping 28 for the feeding of a fluid or of a gas.
  • the fluid flows into the bell 14 through the nozzle 26 as is indicated by the arrows in FIGS. 8 and 9.
  • the fluid flows over the outside of the syringe 6 so that the fluid forms a protective casing.
  • the fluid exits the bell 14 through the opening 16 .
  • the bell serves the purpose of preventing a drifting of the enveloping fluid when the syringe 6 is moved. In this way it can be guaranteed that the protective casing made from the enveloping fluid can be maintained even when there is rapid motion.
  • FIGS. 10 and 11 illustrate how an object, such as s syringe 6 , can be transferred out of a bell 14 and into the fluid environment shown in FIGS. 4 - 7 .
  • FIG. 10 shows a partially cropped side view
  • FIG. 111 shows a partially cropped perspective view.
  • First of all the bell 14 with the syringe 6 arranged in it (see FIGS. 8 and 9) is put in position between the pipes 30 .
  • FIGS. 10 and 11 an arrangement with two pipes 30 is shown.
  • An arrangement with fewer or more pipes, for example, three pipes as explained using FIGS. 6 and 7 might also be provided for.
  • the bell 14 is raised, as a result of which the syringe remains between the pipes 30 .
  • the protective fluid flows out of the pipes 30 through their nozzles 32 , just as out of the gas entry nozzle 26 in the bell 14 , so that the syringe 6 is completely enveloped by the fluid even when the bell 14 is being lifted.
  • the syringe 6 is freely accessible for further processing steps, for example, labeling or inspection or assembly as well as all the work on the outside surfaces.
  • a protective casing is maintained around the syringe 6 by the fluid discharging from the nozzles 32 of the pipes so that a contamination of the syringe 6 from the environmental air can be prevented.
  • the flow of fluid is also indicated with arrows in FIGS. 10 and 11.
  • FIGS. 12 and 13 show an arrangement similar to the FIGS. 4 through 7 in which, however, only a single pipe 30 is planned for.
  • the pipe 30 extends substantially parallel along the longitudinal axis of the syringe 6 so that the nozzles 32 are turned towards the syringe 6 .
  • the discharging fluid envelops as is shown in the horizontal projection shown in FIG. 12, the syringe 6 in such a way that the flow on the back side of the syringe 6 , that is to say on the side of the syringe 6 turned away from the pipe 30 , merges so that a closed liquid casing is formed which protectively encloses the syringe 6 from all sides.
  • Such an arrangement is primarily suited to an object such as a syringe 6 with a round profile, which makes it possible for the liquid to merge.
  • Different types and different numbers of nozzles 32 or pipes 30 have to be arranged around the perimeter of the object depending on the shape and the size of the object to be protected in order to be able to generate a totally enveloping fluid casing around an object.
  • FIG. 14 shows a schematic, overall view of an arrangement for the production and processing of a substantially pure object.
  • the example shown concerns an arrangement for the production of a medical container such as a syringe 6 .
  • the arrangement fundamentally consists of an injection molding machine 36 and a further processing unit 38 .
  • the injection molding machine 36 exhibits two mold halves 2 , 4 from out of which the syringe 6 , as is explained using FIGS. 1 - 3 , is removed using a robotic arm 10 with a gripping device 12 and a bell 14 .
  • a fluid preferably a gas, constantly flows around the syringe 6 in order to protect the syringe from impurities from the environmental air.
  • the further processing unit 38 may be a closed system in which defined environmental conditions prevail.
  • the syringe 6 from the bell 14 is transferred into an arrangement in compliance with FIGS. 4 through 7 or FIGS. 12 and 13, as is explained in more detail using FIGS. 8 and 9.
  • the arrangement of the pipes and a holder for the syringe are configured on a carousel 40 , which forwards the syringe together with the pipes 30 to stations II, III and IV by turning in the direction of the arrow 4 .
  • the number of the required stations depends on the processing steps during the further processing.
  • Other configurations of pipes 30 are shown at stations II, III and IV. This should indicate that different arrangements of pipes 30 , for example in compliance with FIGS. 4 - 7 and 12 - 13 , can be configured on the carousel 40 depending on the application purpose and the type of the object.
  • the further processing steps for the syringe 6 may include, for example, siliconization, inspection, assembly (i.e., with other syringe or container parts or components) and/or filling of the syringe 6 .
  • the syringe 6 is forwarded from station to station at which each processing step is performed, by the turning of the carousel 40 .
  • the pipes 30 turn towards the syringe 6 with the carousel 40 , so that a fluid constantly envelops the syringe 6 .
  • a protective fluid casing can be maintained throughout the entire further processing, which protects the syringe 6 from contaminants from the environment.
  • FIG. 15 shows an alternative arrangement to FIG. 14.
  • the arrangement shown in FIG. 15 is similar to that shown in FIG. 14.
  • the injection molding machine 36 corresponds with the injection molding machine described in FIG. 14.
  • the set up of the gripping device 12 is as explained in FIGS. 1 - 3 .
  • the syringe 6 is removed from the injection molding machine 36 in compliance with the above description and transferred to the further processing unit 38 .
  • FIG. 1 the arrangement shown in FIG.
  • various numbers of pipes 30 could be configured at the respective uptake positions for a syringe 6 , as is shown through the various arrangements at station I, station II and station II.
  • the numbers of the pipes depends on the geometry of the syringe 6 or of an object that is to be protected, and on the processing step to be executed. The arrangement is always selected in such a way that the object or the syringe 6 can be adequately protected from impurities by the surrounding fluid.
  • FIGS. 14 and 15 different arrangements of pipes 30 at the individual stations are shown for the representation of different forms of execution.
  • the syringe 6 is forwarded from station to station in the same arrangement of pipes 30 by the carousel 40 or by the linear table 42 , as is indicated by arrow 4 and arrow 7 .
  • FIG. 16 shows a preferred embodiment of a manufacturing and assembly process for a medical syringe, according to the teachings of the present invention.
  • the process may include a number of separate manufacturing processes that merge during various assembly steps.
  • a number of syringe components including one or more of the barrel, plunger substrate, plunger cover and tip cap, may be molded or otherwise formed in a single facility of separate facilities.
  • the various components may be assembled to form a syringe in a single facility or may be separately packaged and sent to a separate facility for assembly and/or filing with a fluid, such as a drug or other pharmaceutical.
  • the syringe barrel and plunger substrate are molded in a common facility and the plunger cover and tip cap are molded or otherwise formed in separate facilities and are shipped to the common facility where the barrel and plunger substrate are molded for assembly.
  • carriers (not shown) that are used to hold the molded syringe barrels during subsequent shipment may be molded at the same facility (such as in another room) or at a separate facility and then shipped to the common facility for use.
  • the syringe barrel is molded, weighed, siliconized, assembled with a tip cap (shipped from a separate facility), inspected, packaged in a carrier, inserted in a bag, sealed, boxed, sterilized, inspected and then shipped to another facility for subsequent filling with a fluid.
  • the plunger substrate is molded, inspected, assembled, siliconized, assembled with a plunger cover (shipped from a separate facility), packaged, sealed, boxed, sterilized, inspected and then shipped to the same facility as the syringe barrel and tip cap assembly for subsequent placement within the syringe barrel to complete the final syringe assembly.
  • FIG. 17 A facility or room layout for the process shown in FIG. 16 is depicted in FIG. 17.
  • the room or facility 110 is a Class 100,000 clean room.
  • the room includes an injection molding machine 112 for plunger components and a station 114 for plunger siliconization, plunger substrate and plunger cover assembly, and packaging of the assembled plunger.
  • the room 110 includes an injection molding machine 116 for the syringe barrel and a robotic handling machine 118 (described in detail above) for removing the molded syringe barrel from the molding machine 116 .
  • the room also preferably includes a weighing station 122 and a siliconization station 120 for the syringe barrel. After siliconization, the syringe barrel is transferred to a tip cap assembly station 124 , where tip caps (preferably provided from a separate facility) are assembled to the syringe barrels to seal the discharge ends or outlets thereof. Before or after tip cap assembly, the barrels may be inspected at station 130 , by visual or camera inspection, to confirm the quality of the product
  • the assembled barrels are transferred to a packaging station 126 where the barrels are placed on carriers, and the barrels and carriers are placed in bags. The bags are then delivered to a sealing station 128 , where the bags are sealed.
  • FIGS. 18 - 21 illustrate a preferred embodiment of the mold and robotic handling machine of the present invention.
  • the mold 200 preferably includes a movable platen 210 and a stationary or fixed platen 220 and the robotic handling machine 300 preferably includes a robotic arm 310 having a pair of handling devices or grippers 320 for gripping and removing the molded syringe barrels 6 from the mold 200 .
  • the mold 200 may be adapted to mold one, three or more articles and the robotic handling machine 300 may be adapted to include a corresponding number of handling devices 320 .
  • each handling device or gripper 320 preferably includes a partially cone-shaped back plate 330 , an upper semi-cylindrical member 340 and a lower semi-cylindrical member 350 .
  • each of the upper member 340 and the lower member 350 defines a shoulder or flange 375 adapted to engage a circumferential flange 376 formed on the syringe barrel 6 to retain the barrel 6 within the handling device 320 .
  • the back plate 330 , the upper member 340 and the lower member 350 are preferably adapted to form a bell-shaped housing that substantially conforms to the shape of the syringe barrel 6 , as best shown in FIG. 21.
  • the handling devices 320 can be configured to substantially conform to the shape of the article, part, component or object that is being molded.
  • the back plate 330 includes a plurality of nozzles or inlets 360 for delivering a fluid, such as deionized air, to substantially envelope the syringe barrel 6 during removal thereof from the mold 200 and during one or more subsequent processing steps. Also, the alignment of the syringe discharge outlet 106 with one of the inlets 360 allows the fluid to enter the interior of the syringe barrel to prevent contaminants from attaching or adhering thereto.
  • the nozzles or inlets 360 are connected to a source of fluid, which preferably includes a filter for filtering the fluid.
  • the upper member 340 and the lower member 350 may also include one or more inlets 360 for delivering fluid to substantially envelope the barrel 6 .
  • the robotic arm 310 moves linearly between the platens 210 , 220 and the movable platen 210 moves the barrels 6 into position to be gripped by the handling devices 320 .
  • the robotic arm 310 may be translated with respect to the movable platen 210 to position the handling devices 320 to grip the barrels 6 .
  • the robotic arm 310 is linearly removed from between the platens 210 , 220 to move the barrels to a subsequent processing step and to permit the mold platens 210 , 220 to close to form another set of syringe barrels.
  • the molding machine may be a Netstal 1500 injection molding machine provided by Netstal-96 AG of Switzerland; the robotic handling machine may be provided by Hekuma GmbH of Germany; the bag sealing machine may be provided by Koppmaschinessysteme of Germany; and the resin dryer may be provided by Mann-Hummel ProTec GmbH of Germany.

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KR100911955B1 (ko) 2009-08-13
HK1087077A1 (en) 2006-10-06
WO2004048207A2 (fr) 2004-06-10
DE50309813D1 (de) 2008-06-19
ATE394309T1 (de) 2008-05-15
CN100436262C (zh) 2008-11-26
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AU2003292973C1 (en) 2010-01-14
CY1108236T1 (el) 2014-02-12
US7584591B2 (en) 2009-09-08
ES2306912T3 (es) 2008-11-16
CA2507635C (fr) 2011-01-04
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DK1575833T3 (da) 2008-09-01
DE10254762A1 (de) 2004-06-09
JP4557721B2 (ja) 2010-10-06
US8308472B2 (en) 2012-11-13
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CN1726148A (zh) 2006-01-25

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