Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
• • 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
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/04—Heat
  • A61L2/06—Hot gas
  • A61L2/07—Steam
• • 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
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/08—Radiation
• • 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
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/08—Radiation
  • A61L2/10—Ultra-violet radiation
• • 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
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/14—Plasma, i.e. ionised 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
  • 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
  • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases

Definitions

• the present invention relates generally to prefilled delivery devices, such as syringes, for the in vivo delivery of fluids and, more specifically, to methods of producing sterile, prefilled delivery devices without exterior or interior contamination.
• Prefilled delivery devices such as prefilled syringes are known in the art for use in various medical procedures.
• a delivery device is prefilled with the fluid to be dispensed and the entire assembly, including the delivery device and its contents, is then sterilized and supplied for end use.
• prefilled sterile syringes of this type are disclosed in U.S. Patent Nos. 4,628,969 and 4,718,463.
• Contamination of the exterior of a delivery device in an otherwise sterile environment could possibly cause serious illness, perhaps even death.
• Critical medical procedures are typically carried out in sterile environments to ensure that patients are not exposed to infectious agents.
• the exterior of a delivery device were contaminated with an infectious agent and if that delivery device were used during a critical medical procedure, the likelihood that a patient would be exposed to and be infected by an infectious agent would greatly increase.
• An infection in a vulnerable patient undergoing such a medical procedure would clearly affect his ability to recover quickly or, perhaps, to recover at all.
• methods of producing prefilled, sterile delivery devices without exterior or interior contamination include preparing an assembled and sealed prefilled delivery device, sterilizing the assembled and sealed prefilled delivery device and its contents, and aseptically placing the prefilled delivery device in a sterile secondary package which provides a sterile barrier surrounding the delivery device.
• the prefilled delivery device can be non-aseptically placed in a secondary package after sterilization and then the exterior surfaces of the delivery device and the interior of the secondary package can be sterilized while the delivery device is in the secondary package which provides a sterile barrier surrounding the delivery device.
• Another option would be to place the prefilled delivery device in a secondary package prior to sterilization, thus permitting the sterilization of the exterior and interior of the delivery device as well as the interior of the secondary package during the initial autoclaving procedure, thereby eliminating the need for further sterilization.
• Fig. 1 is a sectional view of a prefilled sterile delivery device produced in accordance with the invention.
• Fig. 2 is a sectional view of a prefilled sterile delivery device in a secondary package which provides a sterile barrier surrounding the delivery device in accordance with the invention.
• a prefilled, sterile delivery device for injecting fluid materials indicated generally at 10 and produced in accordance with one embodiment of the present invention includes a housing portion 12 having an opening or passageway 14 at one end which is closed by a sealed tip portion 16. An open end 18 of housing portion 12 is closed and sealed by a rubber piston 20 which can be operated by a handle 22 for expelling the contents 24 through opening or passageway 14.
• the housing portion 12 is produced by a suitable plastic-forming process such as injection molding of a suitable polymer such as polypropylene, or a co-polymer process of polypropylene and polyethylene.
• sealed tip portion 16 including suitable sealing means such as a cap 15 and piston 20 may likewise be produced by injection molding a suitable elastomeric plastic or rubber material to the desired shapes.
• the contents 24 can be any medicinal or diagnostic fluid material including, but not limited to, contrast media.
• the term fluid means a medical fluid and encompasses liquids, gases, or combinations thereof, comprising or containing pharmaceutical media.
• a prefilled delivery device is prepared.
• the prefilled delivery device is a syringe.
• the parts of the delivery device can be individually manufactured and assembled later.
• the delivery device can be assembled and prefilled by any suitable means.
• the parts of the delivery device are manufactured individually, cleaned, and assembled; the assembled delivery device is prefilled; and then the piston 20 is inserted into the open end 18 of the housing portion 12 so as to form a prefilled delivery device and to seal the fluid contents 24 in the delivery device.
• the assembly of the piston 20 includes the evacuation of air from the housing portion 12 via a vacuum system so that the piston 20 can be inserted within the open end 18 of the housing portion 12 with a maximum amount of oxygen- free gas above the level of the fluid contents 24.
• the housing portion 12, opening or passageway 14, and sealed tip portion 16 can be manufactured in a single unit, thus obviating the need for assembling these parts.
• This single unit can be prefilled and then piston 20 can be inserted into open end 18 of housing portion 12 so as to form a prefilled delivery device as described above.
• the assembled and prefilled delivery device is sterilized by any suitable means.
• the assembled and prefilled delivery device can be placed in an autoclave where the prefilled delivery device and its contents can be heated under pressure in a steam/air mixture autoclave.
• the sterile, prefilled delivery device 10 can be aseptically handled by any suitable means including, but not limited to, handling the delivery device with sterile instruments, wearing sterile gloves and/or clothing and the like in a sterile environment, or using sterile solutions after handling the delivery device, and can be placed in any suitable sterile secondary package 30 which provides a sterile barrier surrounding the delivery device so as to provide a sterile, prefilled delivery device without exterior or interior contamination as is depicted in Fig. 2.
• the sterile, prefilled delivery device can be non-aseptically handled and placed in a secondary package 30 which provides a sterile barrier surrounding the delivery device.
• the exterior surface of the prefilled delivery device and the interior of the secondary package may possibly be contaminated from the non-aseptic handling thereof, while the interior surface of the delivery device and the fluid contents therein remain in a sterile condition.
• the prefilled delivery device and the secondary package 30 can then be sterilized by any suitable means so as to eliminate any contamination which might be present on the exterior surfaces of the prefilled delivery device or the interior of the secondary package 30 so as to provide a sterile delivery device without exterior or interior contamination as is depicted in Fig. 2.
• suitable means for sterilizing the prefilled delivery device while it is in the secondary package include, but are not limited to, using hydrogen peroxide, electron beam irradiation, gamma irradiation, ultraviolet irradiation, ethylene oxide, ozonization, gas plasma, peracetic acid, para formaldehyde, glutaraldehyde, or beta propiolactone.
• any suitable breathable or nonbreathable package can be used.
• sterilization agents which require that the sterilizing agent be allowed access to the interior of the secondary package are used, only a suitable breathable package may be used as the secondary package.
• the breathable package must be of such construction that it has pores or openings which are large enough to let the sterilizing agent enter into the interior of the secondary package, while the pores are also small enough to prevent contaminants, pyrogens and the like from entering into the secondary package.
• TyvekTM which is made by Du Pont.
• the exterior surface of the prefilled delivery device and the interior of the secondary package 30 can be sterilized by autoclaving.
• the secondary package 30 is made of a resincus material which can withstand the autoclaving prccess so as to allow the exterior surface of the prefilled delivery device and the secondary package 30 to be sterilized under autoclaving conditions which are not severe enough to affect the amount or composition of the contents 24 of the delivery device i.e., the conditions are not severe enough to cause movement of the fluid contents 24 and/or the piston 20.
• the secondary package 30 when sterilization of the delivery device in the secondary package 30 occurs through autoclaving, that the secondary package is transparent so as to allow quick and easy quality control inspection of the sterile delivery device without exterior or interior contamination, where one of the purposes of the quality control inspection is to ensure that no substantial movement of piston 20 and/or fluid contents 24 occurred during autoclaving which would affect the volume of fluid in the delivery device.
• the prefilled delivery device can be non- aseptically placed in any suitable secondary package 30 which provides a sterile barrier surrounding the delivery device.
• the prefilled delivery device in the secondary package 30 can then be sterilized by any suitable means, such as autoclaving, so that the exterior and interior surfaces of the prefilled delivery device, the fluid contents 24 therein, and the secondary package 30 are all sterilized during the initial sterilization procedure so as to provide a sterile, prefilled delivery device without exterior or interior contamination as is depicted in Fig. 2. Accordingly, no later sterilization procedures need to be undertaken in this embodiment.
• the prefilled delivery device and the secondary package 30 are made of materials which would permit sterilization of the prefilled delivery device without allowing movement of the fluid contents 24 and/or piston 20 during the autoclaving process. It is further preferred that the secondary package 30 is also transparent for the reasons stated above.
• this delivery device can easily be transported to the point of end use and stored in such a manner that the sterility of the delivery device can be maintained so that at the time of end use, the delivery device will be without exterior or interior contamination. That is, at the time of end use, the delivery device of the present invention can be handled by a "gloved" physician in a totally sterile environment without any contact with a possibly contaminated exterior surface of the delivery device.
• this invention provides unique methods of producing sterile, prefilled delivery devices for injection of fluid. The combination of steps forming the methods described above is able to produce sterile, prefilled delivery devices without exterior or interior contamination which have heretofore been impossible to produce utilizing standard production procedures.

Applications Claiming Priority (3)

Publications (2)

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• 1993
  • 1993-12-09 AU AU58987/94A patent/AU5898794A/en not_active Abandoned
  • 1993-12-09 JP JP6514391A patent/JPH08504350A/ja active Pending
  • 1993-12-09 WO PCT/US1993/011959 patent/WO1994013328A1/en not_active Application Discontinuation
  • 1993-12-09 EP EP94905354A patent/EP0673261A4/de not_active Withdrawn
  • 1993-12-14 MX MX9307952A patent/MX9307952A/es unknown

Non-Patent Citations (2)

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