WO2021206673A1 - Appareil médical et procédé de stérilisation d'appareil médical - Google Patents

Appareil médical et procédé de stérilisation d'appareil médical Download PDF

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Publication number
WO2021206673A1
WO2021206673A1 PCT/US2020/026822 US2020026822W WO2021206673A1 WO 2021206673 A1 WO2021206673 A1 WO 2021206673A1 US 2020026822 W US2020026822 W US 2020026822W WO 2021206673 A1 WO2021206673 A1 WO 2021206673A1
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WIPO (PCT)
Prior art keywords
container
medical apparatus
sterilized
protective container
sanitized
Prior art date
Application number
PCT/US2020/026822
Other languages
English (en)
Inventor
Timir Patel
Harish Patel
Original Assignee
Bee Sight Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bee Sight Limited filed Critical Bee Sight Limited
Priority to PCT/US2020/026822 priority Critical patent/WO2021206673A1/fr
Publication of WO2021206673A1 publication Critical patent/WO2021206673A1/fr

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Classifications

    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • 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
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation
    • 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
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • 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
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • the present invention discloses a method for sterilising medical kits or apparatus, including pre-filled syringes, and also the contents of novel, sterilized medical kits comprising, in part, pre-filled syringes.
  • the requirements in terms of the devices and products that will be needed will be more clearly understood.
  • medical professionals will typically gather the devices and products that are likely to be used in the course of the procedure.
  • the devices and products to be employed in a given procedure may be provided in the form of a pre-assembled, pre-sterilised kit or apparatus.
  • An example of such a kit or apparatus is disclosed in W02004093760, which is incorporated herein by reference.
  • kits include a wound care kit, tracheostomy tray, arthroscopy kit, urology irrigation tray, vascular access tray, incision and drainage tray, suture removal kit, saline flush kit, IV start kit, laparoscopy setup pack, TURP pack, ophthalmic pack, biopsy tray, total knee replacement pack, angiography kit, central line kit, PICC trays, C-section setup pack, and cardiac tray.
  • Such kits may contain a pre-filled syringe. Since their introduction in the 1950s, the use of pre-filled syringes in medicine and surgery has increased significantly.
  • pre-filled syringes are syringes that are provided to the end user (e.g., medical professionals) pre-filled and ready to use.
  • pre-filled syringes may be provided in sterilised packaging for added convenience to the end user.
  • kits are generally provided to the end user in a ready to use, sterilised condition. While the sterilisation of certain components conventionally employed in medical kits may not be problematic owing to their ability to withstand harsh sterilisation conditions, the same may not be true for pre- filled syringes either as a result of the material from which the syringe body or various parts of the syringe are formed, or because of the sensitivity of the product contained within the syringe.
  • medical devices formed of metal may be sterilised via heat, steam, irradiation (e.g., gamma irradiation) or exposure to chemicals (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid or nitrogen dioxide).
  • irradiation e.g., gamma irradiation
  • chemicals e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid or nitrogen dioxide.
  • products formed of woven or textile materials e.g., gauzes, bandages
  • cellulose based materials are not compatible with N02 sterilization and require protecting separately.
  • sterilisation approaches which can be used with moisture- and heat-sensitive devices.
  • An example of such an approach which is in widespread use and is immediately of interest, is chemical sterilization, i.e. the sterilization of devices using ethylene oxide or alternatively nitrogen oxide, ozone, peracetic acid, chlorine, chlorine dioxide, hydrogen peroxide or other materials with which one skilled in the art will be familiar.
  • Ethylene oxide is a bactericidal gas which is used widely in the sterilisation of medical devices and products. Sterilisation with ethylene oxide is typically conducted at temperatures in the region of around 40°C to 60°C and under vacuum, for example in accordance with standard ISO 11135 ETO Sterilization for Medical Devices. While this sterilisation approach is capable of being used in connection with products and devices that are heat, moisture and irradiation-sensitive, problems may arise when pre-filled syringes are sterilised with ethylene oxide.
  • the principal concern regarding the use of ethylene oxide sterilisation with pre-filled syringes relates to the ingress of the ethylene oxide into the pre-filled syringe which can contaminate the product within the syringe and lead to unacceptable levels of residual contaminants in that product, especially in the case of products intended for neo-natal and pediatric populations.
  • the concerns regarding the ingress of ethylene oxide into the syringe are especially acute for pre-filled syringes constructed from plastic materials, such as polypropylene, owing to possible leaching of ethylene oxide through the syringe body and contamination of the contents.
  • sterilise kits comprising pre-filled syringes in a single sterilisation operation.
  • the pre-filled syringe is typically separately sterilised from the remainder of the packaged components of the kit using a different sterilisation approach and provided separately and exterior of the packaging containing the remaining components of the kit.
  • Packaging the kit in this way is labor intensive and also risks damage to the externally provided pre-filled syringe during storage and transport of the kit.
  • the container e.g., containing the sterilised syringe(s) or other medical apparatus
  • a gas termed a “primary gas,” which resists penetration of any bacterium or the sterilising gas.
  • the primary gas in the container is preferably inert and sterile, and can be, e.g., nitrogen, argon, helium, etc.
  • the container is filled or prepared with its (pre-sterilized) medical apparatus contents, e.g., sterile syringes (pre-filled or not), in a closed cabinet, such as, in examples, a fume cupboard wherein the gas in the closed cabinet is the primary gas.
  • a closed cabinet such as, in examples, a fume cupboard wherein the gas in the closed cabinet is the primary gas.
  • the primary gas may have also been processed through or with a sterilising cycle, e.g., in a scrubber, to ensure the gas is free or mostly free from any contaminants, including but not limited to bio-active materials, like bacterium, at levels of parts per million.
  • a sterilising cycle e.g., in a scrubber
  • a process for providing an apparatus comprising i) providing a sterile pre-filled syringe contained within a protective container, which protective container is impermeable to moisture and/or sterilizing agents, wherein the container may also comprise a primary gas, ii) providing a kit comprising one or more medical components and the protective container containing the pre- filled syringe, and iii) packaging the kit within a bacterially impermeable package, wherein the container comprises a primary gas (which in cases may be under pressure or not under pressure), which in aspects is an inert gas. (See e.g., FIG. 1.)
  • a method for providing a medical apparatus comprising: i. providing one or more pre-filled syringe contained within one or more first protective container, wherein the one or more first protective container is impermeable to moisture and/or sterilizing agents; ii. providing a second protective container comprising one or more medical components and the one or more first protective container containing the one or more pre-filled syringe; iii. packaging the second protective container within a package impermeable to bacteria; and iv. sealing the first or second protective container so that it includes within the cavity of the first or second protective container a primary gas. (See e.g., FIG. 1.)
  • a medical apparatus comprising: one or more sterile pre-filled syringe; one or more first protective container comprising the one or more sterile pre-filled syringe, wherein the one or more first protective container is impermeable to moisture and/or sterilizing agents; a second protective container comprising one or more medical components and the one or more first protective container; a package impermeable to bacteria comprising the second protective container; and wherein the first or second protective container includes a primary gas present in the cavity of the first or second protective container. (See e.g., FIG. 1.)
  • one device or multiple devices may be included in a primary package, with an inert gas at atmospheric pressure in the primary package, or an inert gas or non-inert gas at elevated pressure.
  • the primary package may be located within a secondary package, wherein the secondary package is completely or partially filed ⁇ with an inert gas at atmospheric pressure, or an inert gas or non-inert gas at elevated pressure, in addition to any such gas in the primary package or as a substitute for any such gas in the primary package.
  • the primary and/or secondary package comprises a one-way septum or valve, such that when the vacuum is pulled during a sterilization cycle, the package empties out of gas, and when the sterilizing gas is introduced, it cannot get into the package, resulting in a vacuum sealed primary or secondary package.
  • This may be included in several ways, including packaging under atmospheric gas, packaging under pressurized gas, injecting gas through a self-sealing septum and leaving the septum as the primary closure, or injecting gas through a septum and adding another closure (e.g., threaded cap) over the septum that is put on after the gas is introduced.
  • a heated pressurized gas inert or not inert, or ozone may be introduced as a way to sterilize the external surface of the syringe, making it sterile-field ready directly out of the primary package, by way of example.
  • a sterilization step to mean a sterilization process which may comprise a single process step or a number of sequential steps or cycles.
  • “Sterilisation” is a process which results in a reduction in the number of viable microbial contaminants of a medical apparatus or kit, or components thereof.
  • FIG. 1 is a schematic diagram of a depiction of one possible embodiment of a medical apparatus described herein.
  • FIG. 2 is a schematic diagram of a depiction of one possible embodiment of a process to prepare a medical apparatus described herein.
  • FIG. 3 is a schematic diagram of a depiction of one possible embodiment of a medical apparatus described herein.
  • FIG. 4 is a schematic diagram of a depiction of one possible embodiment of a medical apparatus described herein.
  • FIG. 5 is a schematic diagram of a depiction of one possible embodiment of a medical apparatus described herein.
  • FIG. 6 is a schematic diagram of a depiction of one possible embodiment of a medical apparatus described herein.
  • FIG. 7 is a schematic diagram of a depiction of one possible embodiment of a medical apparatus described herein.
  • the process includes a principal sterilization step in which the container comprising the pre-filled syringe is sterilized.
  • the principal sterilization step if performed as part of the process of the present invention, is carried out after step ii). In other aspects, this principal sterilization step may be carried out prior to or following step iii) of the process.
  • step iii) preferably takes place in a sterile environment and/or the bacterially impermeable package is sterilized prior to step iii) such that the interior of the bacterially impermeable package is sterilized.
  • additional sterilization steps may be performed after step iii) if needed, for example, to extend the shelf life of the apparatus.
  • the container comprising the pre-filled syringe is preferably not sterilized between steps ii) and iii).
  • the principal sterilization step is carried out after step iii) of the process of the present invention, this results in the interior of the bacterially impermeable package (and thus the assembled kit contained within the interior of the bacterially impermeable package) being sterilized.
  • the principal sterilization step may employ any sterilization approach known to those skilled in the art and which does not result in significant damage or inactivation of any of the components (see, e.g., 1003 in FIG. 1; 2003 in FIG. 2) in the kit.
  • the principal sterilization step may comprise exposing the medical kit to heat, steam (e.g., ISO 17665), irradiation (e.g., gamma irradiation, ISO 11137), nitrogen dioxide (e.g., validated to ISO 14937:2009), and/or ethylene oxide (e.g., ISO 11135).
  • the principal sterilization step comprises exposing the kit to ethylene oxide (EtO or ETO), ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid and/or nitrogen dioxide.
  • a gamma dose may be between 15 kGy and 45 kGY, such as from 17.5 kGY to 35 kGY or 42.6 kGY.
  • the residual ETO in the contents of the syringe is about 5ppm or less, about 2ppm or less, about lppm or less or about 0.5ppm or less.
  • no principal sterilization step is carried out as part of the process of the present invention. Even if no principal sterilization step is carried out as part of the process of the invention, the process still advantageously results in the provision of a packaged kit that can be readily and easily sterilized in a sterilization step.
  • Preliminary sterilization steps may be carried out on the medical components (or part/s thereof) and/or the pre-filled syringe (or part/s thereof) prior to step iii) if required. Any sterilization approach may be employed in these preliminary sterilization steps, depending on the device which is to be sterilized.
  • the preliminary sterilization steps may comprise heat, steam, irradiation (e.g., gamma irradiation), nitrogen dioxide and/or ethylene oxide sterilization.
  • irradiation e.g., gamma irradiation
  • nitrogen dioxide e.g., gamma irradiation
  • ethylene oxide sterilization one, two, three, or more cycles may be used, including in cases after gamma or e-beam sterilization.
  • step i) of the process of the present invention may be achieved by i-a) providing a pre-filled syringe in a cabinet or container or kit, by way of examples, filled with a gas, i-b) placing the pre-filled syringe (see, e.g., 1002 in FIG. 1) within the protective container (see 2005 in FIG. 2), and i-c) sealing the protective container so that the container contains the gas as well as the pre-filled syringe.
  • the gas may be pressurized in the container to at or less than about 45 pounds per square inch (PSI), in embodiments, to ensure ready removal of the seal, including around 45 PSI in order to ensure ready removal of the seal, the PSI of about 45 PSI which would be understood by one of ordinary skill in the art.
  • PSI pounds per square inch
  • the PSI can be up to 50 PSI, 60 PSI, 70 PSI, 80 PSI, 90 PSI, and so on and so forth.
  • the pre-filled syringe may be subjected to a preliminary sterilization step (for example a heat, steam, irradiation (e.g., gamma irradiation), or nitrogen dioxide sterilization step) prior to completely or partially filling the protective container with the primary gas and closure of the protective container (e.g., between steps i-b) and i-c) and/or following step i-c).
  • a preliminary sterilization step for example a heat, steam, irradiation (e.g., gamma irradiation), or nitrogen dioxide sterilization step) prior to completely or partially filling the protective container with the primary gas and closure of the protective container (e.g., between steps i-b) and i-c) and/or following step i-c).
  • a preliminary sterilization step for example a heat, steam, irradiation (e.g., gamma irradiation), or nitrogen dioxide sterilization step) prior to completely or partially filling the protective container
  • a stopper or other way of closing or sealing is made of material, preferably elastomeric, which has a close, secure fit to or with the container inner surface, and can be inserted without forming any defects, which may cause the escape of the primary gas or the sterilising gas to enter.
  • the stopper or closure should not change any dimensions or become degraded during or after the sterilising conditions. Further, the stopper or closure should preferably be readily removable at point of use (e.g., by a clinician).
  • the pre-filled syringe may be provided by providing an unfilled syringe, optionally sterilizing the unfilled syringe (for example, with heat, steam, irradiation (e.g., gamma irradiation), nitrogen dioxide, and/or ethylene oxide), and filling the syringe. (See 2004 in FIG.
  • the pre-filled syringe may be provided by providing the component parts of the syringe, optionally sterilizing the component parts of the syringe (for example, with heat, steam, irradiation (e.g., gamma irradiation), and/or chemical sterilizing agents (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid and/or nitrogen dioxide)), assembling the syringe, optionally sterilizing the assembled syringe (for example, with heat, steam, irradiation (e.g., gamma irradiation), and/or chemical sterilizing agents (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid, and/or nitrogen dioxide)), and filling the syringe.
  • the syringe may be “naked” (e.g., not in a container or package) or already in a container, package, and
  • the protective container may take any form and be formed of any material provided that it prevents the pre-filled syringe contained therein from being rendered transparent during a subsequent sterilization step. It preferably comprises a body and a closure, for example a lid, stopper or cap. In preferred embodiments, the stopper is ethylene oxide proof (or highly resistant) and/or removable.
  • the protective container when closed, may be impermeable to moisture and/or sterilizing agents, such as ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid, and/or nitrogen dioxide.
  • the protective container when closed, is impermeable to ethylene oxide.
  • the protective container when closed and containing the primary gas has the primary gas pressurized in the container to less than 45 pounds per square inch.
  • the protective container and a stopper or other way of closing and/or sealing the protective container is sterilized inside and out before a pre-filled syringe is put into the protective container. (See 1007 in FIG. 1; 2007 in FIG. 2 (e.g., with gamma irradiation)).
  • the prefilled syringe may first be packaged into its own syringe packaging, for example, a sheath, envelope, or wrapper, and optionally sealed therein. (See, e.g., 2004 in FIG. 2.)
  • the pre-filled syringe may optionally be subjected to one or more preliminary sterilization steps which are carried out before and/or after sealing of the syringe packaging, but preferably prior to step i-c).
  • the syringe packaging contains the primary gas.
  • the syringe packaging containing the primary gas comprises materials which are, in aspects, stable in the presence of the primary gas and securely contain the primary gas.
  • the prefilled syringe is provided with syringe packaging
  • this may bear information regarding the prefilled syringe and/or its contents, for example one or more of a label, date of manufacture, batch number, active ingredient, composition, bar code containing information of use/date/name of patient and/or user of that batch, information on type of primary gas being used, or the like.
  • the protective container examples include glass, resin, polymers such as polyolefins, cyclic olefin copolymer, polycarbonate, Si02 coated polymer, polyethylene (e.g., high density polyethylene), metal foil covered plastic, ceramics, metals such as aluminum, and/or composites of two or more of these materials.
  • the protective container is partially or totally formed of reusable, recyclable and/or compostable material, and/or renewable or fossil oil based raw materials. The protective container in aspects will ensure integrity of the seal.
  • the material of the protective container should, in aspects, accommodate any snapping- together or prying-apart ways to open and close the container without fracturing or otherwise breaking.
  • the protective container may be coated and/or the material from which it is produced formulated to achieve the requisite impermeability to sterilisation conditions.
  • the closure of the protective container may be irreversibly separable from the remainder of the protective container.
  • the closure of the container may be formed from the same (or different) material as some or all of the container body but the closure may be defined by a weakened portion of material (e.g., a tear line), facilitating removal of the closure from the container body, e.g., by tearing the closure from the body.
  • a weakened portion of material e.g., a tear line
  • the closure may be mechanically coupled to the body of the protective container, e.g., by friction fit, push-fit, interlocking means, threaded means, or the like.
  • the closure of the protective container may be provided with means to facilitate its removal from the body of the protective container, for example a tab, a pull, knurling, or the like.
  • the protective container may be designed as shown in FIGs. 3-4 and 6 with two (or more) compartments which connect to form a tube which holds, e.g., the syringe.
  • this container may have a twist lock-unlock mechanism which ensures secure closure, such that the final sterilisation process (e.g., using ethylene oxide gas) does not affect the contents of the container, but nevertheless is easy to open under use.
  • a polymer O-ring resides in the twist unlock mechanism so that the sterilisation process material does not enter the contents of the container. (See, e.g., FIGs.
  • This O-ring preferably should be flexible to conform to the cavity in the twist lock-unlock mechanism, thus ensuring a tight seal to maintain extreme sterility of the contents of the container.
  • the-0 ring may be made of a flexible polymer, such as rubber, elastomeric polypropylene , butadiene, or other polymeric material.
  • the protective container is particularly important due to harmful viruses such as, e.g., COVID-19 (“coronavirus”). Such viruses may require exceptional aggressive sterilisation processes, e.g., prolonged treatments from high concentration ethylene oxide. Thus, the flexible seal has to conform in the cavity of the container twist lock-unlock mechanism, and also resist the aggressive sterilisation conditions. [00055] In embodiments in which the pre-filled syringe is subjected to a preliminary sterilization step, this may be before or after it is placed in the protective container.
  • the pre-filled syringe may be subjected to a sterilization step (for example, using heat, steam, irradiation (e.g., gamma irradiation), and/or nitrogen dioxide) and then placed in to the protective container preferably in a sterile environment, and the protective container then closed.
  • a sterilization step for example, using heat, steam, irradiation (e.g., gamma irradiation), and/or nitrogen dioxide
  • the container may be flushed with an inert gas, such as nitrogen, prior to closing and/or sealing.
  • Such operations will usually be performed in a controlled environment such as a sterile room or cabinet (such as a fume cupboard) in accordance with legislative and regulatory guidelines (e.g., class 100 (ISO 5) environments) which should normally minimise the presence of, or ideally yield no, microbiological contaminants.
  • a controlled environment such as a sterile room or cabinet (such as a fume cupboard) in accordance with legislative and regulatory guidelines (e.g., class 100 (ISO 5) environments) which should normally minimise the presence of, or ideally yield no, microbiological contaminants.
  • the pre-filled syringe may be placed into the protective container and the closure means optionally partially closed (such that the container is not totally sealed).
  • the protective container and pre-filled syringe may then conveniently be sterilized in a single sterilization operation, e.g., using heat, steam, irradiation (e.g., gamma irradiation), and/or nitrogen dioxide, prior to closure of the protective container.
  • the process of the present invention may additionally comprise the step of applying a supplementary barrier to the protective container.
  • the purpose of this is to provide additional protection to the pre-filled syringe to prevent it being rendered opaque in any subsequently performed sterilization step.
  • the supplementary barrier may be applied to some or all of the protective container.
  • the supplementary barrier is provided at least to the closure of the container and a region of the container adjacent to the closure.
  • the supplementary barrier may additionally comprise compounds which absorb or react with the sterilizing gas, e.g. ethylene oxide, so that the container is made impermeable to said sterilizing gas.
  • Any material which enhances the barrier properties of the protective container may be employed as a supplementary barrier in the process of the present invention.
  • the supplementary barrier may be a metallic foil, polymeric film, or the like.
  • the supplementary barrier is an aluminum foil (see, e.g., 2008 in FIG. 2).
  • the supplementary barrier may be provided with an adhesive to facilitate intimate contact with the protective container.
  • the supplementary barrier is adhered to the protective container.
  • the barrier and/or adhesive may additionally comprise chemical compounds or other ways to trap or scavenge any ingressed sterilizing gas.
  • the interior of the protective container may comprise an ethylene oxide scavenger (see, e.g., 2009 in FIG. 2).
  • an ethylene oxide scavenger see, e.g., 2009 in FIG. 2.
  • the purpose of the ethylene oxide scavenger is to capture any ethylene oxide that ingresses into the protective container and prevent it from contaminating the pre-filled syringe or other components contained therein.
  • the ethylene oxide scavenger may be a material which converts ethylene oxide into a harmless material and/or which entraps, co-ordinates, or adheres to ethylene oxide, thus rendering it harmless.
  • Ethylene oxide is highly reactive and undergoes reactions with a variety of compounds: preferably these compounds are such that a reaction with any ethylene oxide converted to harmless materials is of little concern to the contents of the protective container.
  • Examples of such compounds include, but are not limited to, water, alcohols, amines, halides, organometallic compounds, cyanides, sulphides, nitrous or nitric acids, and/or compounds comprising active methylene groups.
  • Examples of compounds which may be employed as ethylene oxide scavengers include alkaline compounds, for example salts of carboxylic acid; co-ordinating ligands such as EDTA or derivatives thereof; buffered amine solutions; and/or alcohol.
  • the ethylene oxide scavenger may be provided on and/or impregnated in a substrate, for example one which maximizes the surface area of the ethylene oxide scavenger, such as a woven (e.g., a gauze or gauze-like material) or sponge-like material.
  • a substrate for example one which maximizes the surface area of the ethylene oxide scavenger, such as a woven (e.g., a gauze or gauze-like material) or sponge-like material.
  • the ethylene oxide scavenger may be located in a region of the container where ethylene oxide is most likely to be found.
  • the ethylene oxide scavenger may be located in the region of the margin between the lid and the container.
  • the use of an ethylene oxide scavenger may be of particular interest to those engaged in the packaging of surgical kits intended for use in procedures to be conducted on pediatric or neonatal patients, for which restrictions on the tolerable levels of ethylene oxide are more stringent.
  • the interior of the container may be provided with antimicrobial agents or other ways to perform sterilization of the container.
  • agents or procedures may comprise an antimicrobial agent, for example silver compounds such as nano-silver and /or silver nitrate; alcohols; and/or high molecular weight amines. Additional examples of antimicrobial agents which may be employed as antimicrobial agents in the present invention are disclosed in paragraphs [0121] to [0150] of U.S. Patent Publication No. 2012/0283693, the contents of which are incorporated by reference.
  • both an antimicrobial agent and an ethylene oxide scavenger are provided in the interior of the protective container.
  • the antimicrobial agent and the ethylene oxide scavenger are the same material or product.
  • an antimicrobial agent and/or an ethylene oxide scavenger may be provided in the vicinity of the opening of the protective container.
  • the antimicrobial agent and/or an ethylene oxide scavenger may also be provided within a component of the pre-filled syringe, for example a cap protecting the luer of the syringe.
  • the antimicrobial agent and the ethylene oxide scavenger may both be provided on and/or impregnated in a substrate.
  • Those skilled in the art will be familiar with the construction of syringes that may be employed in the kits.
  • One advantage of the process and kit of the present invention is that the user of the process and kit is not constrained to selecting a syringe formed from only a limited number of materials.
  • the syringe body may be formed of glass, polyethylene (e.g., high density polyethylene), polypropylene (e.g., medical grade radiation stable polymer), cyclo olefin polymer or cyclo olefin copolymer (e.g., Topas), or Si02 coated polymer.
  • polyethylene e.g., high density polyethylene
  • polypropylene e.g., medical grade radiation stable polymer
  • cyclo olefin polymer or cyclo olefin copolymer e.g., Topas
  • Si02 coated polymer Si02 coated polymer
  • the protective container provided in step i) of the process of the present invention comprises one pre-filled syringe.
  • the protective container may comprise a plurality of pre-filled syringes, e.g., 2, 3, 4, 5, 6 or more than 6.
  • the syringe included in the kit may be filled with any material that may be usefully employed in surgery or other medical procedures.
  • the syringe may be pre-filled with saline, e.g., a flush syringe.
  • the prefilled syringe could be filled with a lock solution which can be used to maintain sterility in devices such as catheters between uses.
  • lock solutions include lower alcohols, such as ethanol, propanol and/or butanol.
  • the lock solution may also comprise an antimicrobial (such as taurolidine and/or triclosan) and or an anticoagulant (such as riboflavin, sodium citrate, ethylene diamine tetraacetic acid, and/or citric acid).
  • the prefilled syringe may be pre-filled with an active pharmaceutical composition.
  • the active pharmaceutical composition may be heat sensitive (e.g., which may be denatured and rendered non) at temperatures in excess of about 50°C, about 60°C, about 70°C, about 80°C, about 90°C, or about 100°C.
  • step ii) of the process another protective container, also referred to herein as a kit, comprising the protective container housing the pre-filled syringe and one or more other medical components.
  • a kit comprising the protective container housing the pre-filled syringe and one or more other medical components.
  • the identity of the other components will depend on the procedure for which the kit or apparatus is intended to be used. However, there are no particular limitations on the identity of the other components.
  • the second protective container may, in embodiments, with its cover open, be placed into an ETO chamber and sterilised with ETO or other sterilization techniques.
  • the ETO cycle may include aeration and vacuum steps to remove residual ETO.
  • the kit may be closed and/or sealed and optionally further ETO sterilization, or other sterilization, of the closed and/or sealed kit may be performed.
  • the other components are selected from one or more of the following: scalpels, needles, forceps, sutures, gauzes, bandages, catheter pads, face masks, IV bag holder, needle foam positioning, prep sponges, Prevantics® pads, swab sticks, syringes, tourniquets and wallet exam gloves.
  • the medical kit provided in step ii) of the process of the present invention may additionally comprise a packaging base which is configured to retain some or all of the components of the kit (including the protective container) thus preventing them from moving freely within the packaging during transport and handling of the kit, in order to minimise the risk of damage.
  • the medical kit may comprise a plurality of protective containers in the kit, for example, 2, 3, 4, 5, 6, 7, 8, or more than 8.
  • all of the pre-filled syringes within the protective container may comprise the same formulation and/or comprise the same volume of formulation.
  • the pre-filled syringes contained within those containers may vary in terms of the formulations comprised therein and/or in terms of the volume of formulation comprised therein.
  • the containers and/or the packaging base may be numbered or labelled to facilitate the correct and consistent positioning of the containers within the kit.
  • the additional protective containers may be sterilized and/or constructed as discussed herein.
  • the medical components and/or the retaining base may independently be subjected to preliminary sterilization steps (for example, with heat, steam, irradiation (e.g., gamma irradiation), and/or chemical sterilizing agents (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid, and/or nitrogen dioxide)) prior to step ii) of the process of the present invention.
  • preliminary sterilization steps for example, with heat, steam, irradiation (e.g., gamma irradiation), and/or chemical sterilizing agents (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid, and/or nitrogen dioxide)
  • the kit or second container is packaged within a bacterially impermeable package.
  • the package may be formed of any material provided that it is capable of providing a sterile enclosure containing the medical kit. In embodiments, the package is capable of preventing microbial penetration. Examples of bacterially impermeable packaging which may be employed in step iii) of the process of the present invention include, but are not limited to, woven or non-woven materials.
  • non-woven package materials examples include polymeric (e.g., cellulose and/or polypropylene-based packaging wraps) which include materials made from renewable, recyclable material, such as bioplastics from starches, cellulose and/or biopolymers.
  • the package is formed of a single or multi laminate packaging material comprising one or more polypropylene layers.
  • the packaging material may be a multilaminate wrap comprising 1, 2, 3, or more than 3 polypropylene layers.
  • one or more of the polypropylene layers may be spunbonded, and/or one or more of the propylene layers may be meltblown.
  • packaging materials examples include, but are not limited to, trilaminates in which the upper and lower layers (i.e., the outer layers) are spunbonded polypropylene and the inner layer is meltblown polypropylene.
  • trilaminates will be known to those skilled in the art as 'SMS' materials.
  • Such trilaminates may be used in a single layer arrangement, or multi-layered arrangement, e.g. comprising 1,
  • the single layered or multilaminate packaging materials that may be employed in the process of the present invention include those commercialized by Halyard under the trade name Kimguard, by Cardinal Health under the trade name Sterilization Wrap, and by Ahlstrom Fabrics under the name Med-Con.
  • a woven material that may be employed is muslin, optionally multiple wrapped (e.g., double, sequential wrapped) muslin, and/or polyester-cohon blends which are optionally chemically treated.
  • the step of packaging the kit may be achieved by surrounding the kit with the packaging material and sealing the packaging material (e.g., via heat sealing, adhesion, or the like) to close the package around the kit.
  • the packaging material may conveniently be provided in the form of a bag into which the kit can be placed, and the bag then sealed (e.g., via heat sealing or using adhesive).
  • the packaging material is impermeable to sterilization media (e.g., steam and/or chemical sterilizing agents (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid, and/or nitrogen dioxide)).
  • sterilization media e.g., steam and/or chemical sterilizing agents (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid, and/or nitrogen dioxide)
  • the packaging material is partially closed during sterilization to allow the sterilisation medium to sterilize the inside of the packaging. After sterilization has taken place, the packaging material is fully closed and/or sealed.
  • the packaging material is preferably permeable to sterilization media (e.g., heat, steam, gamma irradiation, and/or chemical sterilizing agents (e.g., ethylene oxide, ozone, chlorine, chlorine dioxide, hydrogen peroxide, peracetic acid, and/or nitrogen dioxide)), such that sterilization of the entirety of the packaged medical kit can be conveniently sterilized in a sterilization step. Sterilisation may be carried out before the packaging material is closed.
  • the bacterially impermeable package is permeable to sterilizing gas, for example ethylene oxide.
  • the package also exhibits one or more of the following properties: aeratability (e.g., the package permits aeration post sterilisation for example to dissipate ethylene oxide), low or no toxicity, minimal wrap memory, drapeability (such that the package conforms to the kit), flexibility, puncture resistance, tear resistance, low or no odour, low or no linting, and/or conformity with waste disposal regulation.
  • aeratability e.g., the package permits aeration post sterilisation for example to dissipate ethylene oxide
  • low or no toxicity low or no toxicity
  • minimal wrap memory such that the package conforms to the kit
  • drapeability such that the package conforms to the kit
  • flexibility puncture resistance, tear resistance, low or no odour, low or no linting
  • conformity with waste disposal regulation e.g., the package permits aeration post sterilisation for example to dissipate ethylene oxide
  • the packaged kit may be subjected to one or more supplementary packaging steps, e.g. to provide the kit in packaging which provides greater protection during transit and/or which displays product information to the end user of the overall apparatus.
  • the kit may be subjected to an evacuation step, to remove traces of ethylene oxide from the kit prior to and/or following closure of the packaging material in step iii).
  • the kit additionally comprises instructions for use. These instructions may provide medical professionals with guidance as to how the medical kit should be employed, for example in procedures to be carried out on pediatric or neonatal patients.
  • identification means such as bar code labels may be provided to the kit and/or its contents for ready capture of information into a readable format, e.g. on a computer screen.
  • the instructions may provide guidance as to how the medical kit may be sterilized. For example, if the medical kit packaged in step iii) is made in whole or in part of ethylene oxide permeable packaging, the instructions may provide guidance as to how ethylene oxide sterilization may be performed on that packaged medical kit.
  • a syringe having a polypropylene body was filled with 20ml sterile 0.9% saline solution compliant with the US Pharmacoepia.
  • the syringe was then packaged in a protective container (glass vial) together with an ethylene oxide (ETO) detector strip (which is red at the start and turns green on exposure to ETO).
  • ETO ethylene oxide
  • the vial was then stoppered tightly with a rubber stopper and a ring pull over holder. There existed a tight fit of the stopper without defects so that the ETO sterilant will not ingress.
  • an optional aluminum foil was applied over the stopper of the vial and also over the crevice at the boundary of the cap and the vial.
  • the foil was tightly wrapped around the protective container and was additionally provided with adhesive to ensure an intimate and durable connection with the protective container.
  • a kit comprising the protective container was then assembled and packaged in a surgical wrap material comprising two layers of SMS bonded to each other.
  • the kit was placed in a chamber 3M Steri-Vac 8XL ETO Gas Sterilizer and ETO was introduced as shown below.
  • ETO EXPOSURE 7 HOURS WITH THEORETICAL ETO GAS
  • residual ETO levels of the contents of the syringe will be about 5ppm or less, more preferably about lppm or less or most preferably about 0.5ppm or less.
  • the closure means for the container should be robustly and smoothly fitted so that all sources of defects (however small) caused by the closing technique are avoided. Otherwise, the ETO ingresses readily into the interior of the container and inevitably into the contents of the pre-filled syringe;
  • the elastomeric stopper was found to be insertable and enabled prevention of any ETO ingress.
  • Stringent closure is required to achieve the very low value (e.g., less than 5ppm, less than 1 ppm, or less) of ETO ingress required for some of the pre-filled syringe products; and [000111] glass and/or aluminum containers are preferred.
  • the tests were repeated but this time utilizing a primary gas contained within the container comprising the syringe.
  • the primary gas in one example, was nitrogen, but, in aspects, the primary gas may be, for example only, argon, oxygen, helium, or any combination thereof.
  • An ETO detector strip was used as a tool to determine which containers failed to prevent ingress by the ETO.
  • the failure rate decreased in a batch of 100 containers, when the containers contained a primary gas, in this case nitrogen gas, meaning inclusion of a primary gas improved prevention of the ingress of ETO.
  • a primary gas in this case nitrogen gas
  • the presence of a primary gas caused a significant improvement in preventing ingress of ETO.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

Selon des modes de réalisation, l'invention concerne un appareil médical comprenant une ou plusieurs seringues préremplies stériles, un ou plusieurs premiers contenants de protection comprenant ladite une ou lesdites plusieurs seringues préremplies stériles, le premier contenant de protection pouvant être entièrement ou partiellement rempli d'un gaz inerte ou non inerte, ledit un ou lesdits plusieurs premiers contenants de protection étant imperméables à l'humidité et/ou aux agents de stérilisation, et un deuxième contenant de protection comprenant un ou plusieurs constituants médicaux et ledit un ou lesdits plusieurs premiers contenants de protection, le deuxième contenant de protection pouvant être, mais n'étant pas nécessairement, complètement ou partiellement rempli d'un gaz inerte ou non inerte. Selon certains aspects, un emballage essentiellement imperméable aux bactéries comprenant le(s) premier(s) contenant(s) et le deuxième contenant de protection est également complètement ou partiellement rempli d'un gaz inerte ou non inerte.
PCT/US2020/026822 2020-04-06 2020-04-06 Appareil médical et procédé de stérilisation d'appareil médical WO2021206673A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5997811A (en) * 1997-07-02 1999-12-07 Cohesion Technologies, Inc. Method for sterile syringe packaging and handling
US20030158512A1 (en) * 1997-04-10 2003-08-21 Johns Hopkins University Pre-filled package containing unit dose of medical gas and method of making same
US20090123332A1 (en) * 2008-01-15 2009-05-14 Crosstex International, Inc. Sterilization pouch with internal and external indicators
US20170281876A1 (en) * 1998-03-13 2017-10-05 Becton, Dickinson And Company Method and Apparatus for Manufacturing, Filling and Packaging Medical Devices and Medical Containers
US20180221564A1 (en) * 2017-02-03 2018-08-09 Bee Sight Limited Medical apparatus and method for sterilizing medical apparatus

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030158512A1 (en) * 1997-04-10 2003-08-21 Johns Hopkins University Pre-filled package containing unit dose of medical gas and method of making same
US5997811A (en) * 1997-07-02 1999-12-07 Cohesion Technologies, Inc. Method for sterile syringe packaging and handling
US20170281876A1 (en) * 1998-03-13 2017-10-05 Becton, Dickinson And Company Method and Apparatus for Manufacturing, Filling and Packaging Medical Devices and Medical Containers
US20090123332A1 (en) * 2008-01-15 2009-05-14 Crosstex International, Inc. Sterilization pouch with internal and external indicators
US20180221564A1 (en) * 2017-02-03 2018-08-09 Bee Sight Limited Medical apparatus and method for sterilizing medical apparatus

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