CA2502888C - Drug cartridge assembly and method of manufacture - Google Patents
Drug cartridge assembly and method of manufacture Download PDFInfo
- Publication number
- CA2502888C CA2502888C CA2502888A CA2502888A CA2502888C CA 2502888 C CA2502888 C CA 2502888C CA 2502888 A CA2502888 A CA 2502888A CA 2502888 A CA2502888 A CA 2502888A CA 2502888 C CA2502888 C CA 2502888C
- Authority
- CA
- Canada
- Prior art keywords
- drug cartridge
- cleanroom
- nozzle
- nozzle subassembly
- assembly
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
Links
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
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/081—Gamma radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
- A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
- A61M2005/2462—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2485—Ampoule holder connected to rest of syringe
- A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
- A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
- A61M2005/287—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3104—Caps for syringes without needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M2005/3132—Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/1782—Devices aiding filling of syringes in situ
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
- A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49904—Assembling a subassembly, then assembling with a second subassembly
Abstract
A method of manufacture for a drug cartridge assembly. The method includes providing a drug cartridge, providing a nozzle sub-assembly, and sterilizing the drug cartridge and nozzle sub-assembly. The method further includes assembling the drug cartridge and nozzle sub-assembly together in a configuration that enables ejection of liquid out of the drug cartridge through the nozzle sub-assembly. The method further includes filling the drug cartridge with a liquid, such as an injectable drug. The method may include separate sterilization of the drug cartridge and nozzle sub-assembly, using different sterilization processes. Portions of the method may be performed prior to sterilization within a first cleanroom, with subsequent steps being performed in a second cleanroom having a substantially lower particulate-per-volume rating than the first cleanroom.
Description
DRUG CARTRIDGE ASSEMBLY AND METHOD OF MANUFACTURE
Background of the Invention The invention relates to a method of manufacture for a drug cartridge assembly configured for use in providing an injection.
Drug cartridge assemblies and other injection devices commonly include a number of different components. Typically, several of the components are fabricated from plastic, because plastic is durable and relatively inexpensive. Plastic, however, normally is not the material of choice for the container that holds the drug. Certain elements present in plastics may interact with certain drugs, for example, or may leach into and contaminate the drug. Accordingly, the liquid drug is often held within a container, such as a vial or cylindrical cartridge, which is made from medical grade borosilicate glass.
Drug cartridge assemblies must be relatively free of contamination.
Sterilization and cleaning of components are therefore important considerations in any process used to manufacture a drug cartridge assembly. Many existing manufacturing methods employ cleaning and sterilization techniques that are ill-suited for use in preparing drug cartridge assemblies, or other sterile devices constructed from multiple components. In particular, existing manufacturing methods often employ sterilization processes that, while appropriate for some components, are ineffective or harmful when used on other components. In addition, existing manufacturing methods often do not efficiently utilize cleanroom environments, and thereby add unnecessarily to manufacturing costs.
Background of the Invention The invention relates to a method of manufacture for a drug cartridge assembly configured for use in providing an injection.
Drug cartridge assemblies and other injection devices commonly include a number of different components. Typically, several of the components are fabricated from plastic, because plastic is durable and relatively inexpensive. Plastic, however, normally is not the material of choice for the container that holds the drug. Certain elements present in plastics may interact with certain drugs, for example, or may leach into and contaminate the drug. Accordingly, the liquid drug is often held within a container, such as a vial or cylindrical cartridge, which is made from medical grade borosilicate glass.
Drug cartridge assemblies must be relatively free of contamination.
Sterilization and cleaning of components are therefore important considerations in any process used to manufacture a drug cartridge assembly. Many existing manufacturing methods employ cleaning and sterilization techniques that are ill-suited for use in preparing drug cartridge assemblies, or other sterile devices constructed from multiple components. In particular, existing manufacturing methods often employ sterilization processes that, while appropriate for some components, are ineffective or harmful when used on other components. In addition, existing manufacturing methods often do not efficiently utilize cleanroom environments, and thereby add unnecessarily to manufacturing costs.
Summary of the Invention The present invention provides a method of manufacture for a sterile device such as a drug cartridge assembly. The method includes providing a drug cartridge, providing a nozzle sub-assembly, and sterilizing the drug cartridge and nozzle sub-assembly. The method further includes assembling the drug cartridge and nozzle sub-assembly together in a configuration that enables ejection of liquid out of the drug cartridge through the nozzle sub-assembly. The method also includes filling the drug cartridge with a liquid, such as an injectable drug.
Sterilization of the drug cartridge and nozzle sub-assembly may be performed separately, using different types of sterilization processes. Also, part of the method may be performed prior to sterilization within a first cleanroom, with subsequent steps being performed in a second cleanroom, where the second cleanroom has a substantially lower particulate-per-volume rating than the first cleanroom.
Some embodiments disclosed herein relate to a method of manufacturing a drug cartridge assembly, where the drug cartridge assembly includes a prefilled drug cartridge connected with a nozzle sub assembly that is configured to facilitate injection of liquid from the drug cartridge through an opening in the nozzle subassembly, the method comprising: preassembling the nozzle subassembly; sterilizing the preassembled nozzle subassembly with a radiation based sterilization process; sterilizing the drug cartridge with a separate, thermal based sterilization process; filling the drug cartridge; and disposing the drug cartridge in a readytouse position within the nozzle sub assembly, wherein the step of preassembling the nozzle sub assembly is performed within a first cleanroom, and where filling the drug cartridge and positioning the drug cartridge within the nozzle subassembly is performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
Some embodiments disclosed herein relate to a method of preparing a sterile drug cartridge assembly, comprising: providing a drug cartridge;
providing a nozzle subassembly, where the drug cartridge and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the drug cartridge out through the nozzle subassembly; assembling the nozzle subassembly and otherwise preparing the nozzle sub assembly for sterilization in a first cleanroom;
sterilizing the nozzle subassembly; sterilizing the drug cartridge; and positioning the drug cartridge in a ready to use position within the nozzle sub assembly, and filling and sealing the drug cartridge, where the positioning, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
Some embodiments disclosed herein relate to a method of manufacturing a sterile injection device, comprising: providing a liquid container;
providing a nozzle subassembly, where the liquid container and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the liquid container out through the nozzle subassembly; preparing the nozzle subassembly for sterilization, where such preparation is performed in a first cleanroom;
sterilizing the nozzle subassembly via irradiation; sterilizing the liquid container separately from the nozzle subassembly using a thermal sterilization process; and securing the liquid container and nozzle subassembly together, and filling and sealing the liquid container, where the securing, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
Brief Description of the Drawings Fig. 1 is a sectional view of a drug cartridge assembly.
Fig. 2 is an exploded view of the drug cartridge assembly of Fig. 1.
Fig. 3 is a schematic view depicting exemplary methods that may be used to assemble the drug cartridge assembly of Figs. 1 and 2, and prepare it for use in providing an injection.
3a Detailed Description of the Preferred Embodiment(s) The following description will address various implementations of a method of manufacture for a sterile device. The methods are widely applicable, though they are particularly advantageous where the device is to be constructed from multiple components or from more than one type of material, where certain sterilization processes pose problems relating to only a portion of the device, and/or where it is important that certain steps be carried out in cleanroom-type environment.
The methods described herein may, for example, be advantageously employed to prepare a variety of drug cartridge assemblies and other sterile medical devices.
For purposes of illustration only, the exemplary methods described herein will be discussed primarily in the context of a drug cartridge assembly. Further discussion and examples of drug cartridges and cartridge assemblies may be found in U.S. Patent No. 6,132,395, by Sergio Landau and James M. Bonicatto, entitled "Needleless Syringe With Prefilled Cartridge", which issued on October 17, 2000, and U.S. Patent No. 6,383,168, by Sergio Landau and James M. Bonicatto, entitled "Needleless Syringe with Prefilled Cartridge", which issued on May 7, 2002.
Figs. 1 and 2, respectively, depict a sectional view and an exploded view of a drug cartridge assembly 10. As shown, drug cartridge assembly 10 typically includes a liquid container, such as drug cartridge 12, and a nozzle 14. In the depicted example, nozzle 14 also serves as a housing for cartridge 12, as shown in Fig. 1, although a housing may be provided separately from nozzle 14, or may be omitted altogether. The depicted exemplary cartridge is formed as an open-ended cylinder, though other shapes and configurations may be employed, as desired.
A cartridge seal 16 may be provided at end 12a of cartridge 12, to maintain liquid 20 (e.g., a dose of drug) within cartridge 12 until it is to be ejected from drug cartridge assembly 10. Cartridge seal 16 may be implemented in a variety of ways, in order to maintain liquid 20 within cartridge 12 until the user desires to eject the liquid, for example, to administer an injection. As shown, cartridge seal 16 may be implemented as a ball-type check valve, including a ball 22 and a sealing member 24. Sealing member 24 may be secured with end 12a of cartridge 12, and includes a seat 24a. When ball 22 engages seat 24a, the end of the cartridge is sealed. A spring or other biasing member (not shown) may be provided to urge ball 22 upward into sealing engagement with seat 24a. Typically, a plunger 26 or like structure is provided to seal opposing end 12b of cartridge 12. As shown in Fig. 1, liquid 20 may thus be sealed within drug cartridge 12 by cartridge seal 16 and plunger 26.
Nozzle 14 typically includes an opening 14a through which liquid 20 from cartridge 12 may be ejected. Opening 14a may have any practicable dimensions, though it typically is narrower than the interior of cartridge 12. Use of a relatively narrow opening may facilitate high-pressure ejection of liquid 20, and enable injection of the liquid into a well-defined injection site. The end of nozzle 14 may be fitted with a removable cap 30 when drug cartridge assembly 10 is not being used, for example during shipping or storage.
As discussed above, nozzle 14 typically houses drug cartridge 12, though it will be appreciated that the nozzle 14 may take alternate forms. For example, nozzle 14 may be formed as a structure which is positioned on, or connected to, end 12a of cartridge 12, without wrapping around or otherwise enclosing the body of the cartridge.
Also, though cartridge seal 16 is a separate component in the depicted example, it should be appreciated that the seal may be formed integrally with nozzle 14 and/or cartridge 12.
The various components of drug cartridge assembly 10 may be made from a variety of different materials, including metals, plastics and other polymeric materials, ceramics, etc. Typically, in the depicted exemplary device, nozzle 14, cap 30, ball 22 and sealing member 24 are fabricated from plastic, or from another polymeric material.
Additionally, it will often be desirable to form sealing member 24 and/or ball 22 from an elastic, resilient material, such as rubber, in order to facilitate effective sealing.
Typically, use of polymeric materials as described above provides for cost-efficient manufacture and a durable device.
Though many components of drug cartridge assembly 10 can be advantageously formed from plastic, it will in many cases be preferable to manufacture drug cartridge 12 from glass, instead of from plastic or other materials. Use of thermoplastic containers, for example, may involve risks of interaction between the drug and the container. The drug may chemically react with the plastic, or may cause materials in the plastic to leach into the drug, thereby introducing impurities in the drug. In periods of extended storage, such exposure to a plastic container may result in degradation of the drug. In certain applications, glass may also be easier to clean and sterilize during initial preparation, and/or when being recycled for subsequent additional uses. It should be appreciated, however, that drug cartridge 12 may nonetheless be made from plastic or other materials other than glass.
It will often be desirable to provide drug cartridge assembly 10 to the end user as a pre-filled, ready-to-use assembly that has already been sterilized. The user would then simply need to remove cap 30 and operatively engage drug cartridge assembly 10 with an injection device (not shown), and then an injection could be administered. As shown in Fig. 2, threads 32 or another attachment mechanism may be provided to facilitate engagement of drug cartridge assembly 10 with an injection device. Typically, threads 32 are positioned on the outer surface of nozzle 14 opposite nozzle opening 14a.
An injection may be administered by forcing plunger 26 toward nozzle opening 14a (i.e., downward in Fig. 1) to apply pressure to liquid 20. Plunger 26 may be forced downward via movement of a plunger rod (not shown) or other structure brought into contact with plunger 26, through application of fluid pressure to plunger 26, or through other appropriate methods and structures. Upon application of sufficient pressure to the liquid supply, ball 22 is forced out of engagement with seat 24a and downward into a cavity 14b formed near the forward end of nozzle 14. When ball 22 is in this advanced state, liquid 20 from drug cartridge 12 can flow within cavity 14b around ball 22 and out through nozzle opening 14a.
When drug cartridge assembly 10 is provided in the ready-to-use configuration described above and shown in Fig. 1, the end user does not have to fill the injection device with a measured dose of injectable liquid, as is required with many existing injection devices. Filling adds an extra step, and can increase the risk of contaminating the liquid dose with air bubbles or other contaminants. Filling can also lead to spilling of the drug, and increases the risk that the user will come into undesired contact with the drug. In addition, a sterile adapter fitting is often required to couple the liquid container of the injection device with a source of injectable liquid. Accordingly, in most cases it will be desirable to implement drug cartridge assembly 10 in a pre-filled, ready-to-use state, as described.
Fig. 3 schematically depicts an exemplary method which may be used to prepare drug cartridge assembly 10. As will be explained, the method may include various assembly steps, it may be siliconized, and may be subjected to washing and other sterilization processes prior to packaging for shipment.
In many cases, it will be desirable to implement some or all of the method in a cleanroom or other controlled setting where airborne contamination is reduced from normal levels. For example, some preparation steps may be performed within cleanroom 40,.which, as shown, may be a class 10,000 cleanroom. Specifically, as shown in Fig. 3, cartridge seal 16 may be assembled within cleanroom 40 by inserting ball 22 into sealing member 24. Cartridge seal 16 is then positioned within the interior of nozzle 14, so that it generally covers nozzle opening 14a in a position that enables the cartridge seal to seal between open cartridge end 12a and nozzle opening 14a. Cap 30 may also be secured in place on the end of nozzle 14. The assembled components are designated at 50, and may be referred to collectively as the nozzle sub-assembly. Although the depicted nozzle sub-assembly is fabricated from a number of separate components, it should be understood that nozzle sub-assembly may be formed as a single unitary piece.
The term "cleanroom" as used herein should not be limited to an entire room, but might alternatively be a clean area, such as that defined under a laminar flow hood.
While nozzle sub-assembly 50 is still within cleanroom 40, nozzle sub-assembly 50 may be packed within a sterile container, such as double bag 52. As discussed below, the depicted exemplary method also includes radiation-based sterilization of nozzle sub-assembly 50. Accordingly, it will typically be preferred that the double bag 52 or other container used for nozzle sub-assembly 50 be suitable for exposure to radiation.
Alternatively, nozzle sub-assembly 50 may be removed from the initial packaging prior to radiation sterilization. It will often be preferable, however, to maintain nozzle sub-assembly 50 within the sterile packaging until final assembly of the nozzle sub-assembly with other components of drug cartridge assembly 10 (discussed below).
As discussed above, the components of drug cartridge assembly 10 may be fabricated from different materials. Sterilization and cleaning techniques that are suitable for one type of material may not be appropriate for another. Also, the particular way a component is used may affect what methods of cleaning and sterilization are most advantageous. Drug cartridge 12, for example, typically comes into direct contact with liquid (e.g., with a dose of an injectable drug). Accordingly, it will typically be desirable to wash and rinse drug cartridge 12 at some point during the preparation of cartridge assembly 10. Washing normally is performed during initial manufacture, and between uses where drug cartridge 12 is recycled for multiple uses. Although it is typical to wash cartridge 12, washing may not be appropriate or necessary for nozzle 14, or for the other components of drug cartridge assembly 10.
Similarly, radiation-based sterilization may not be suitable for all of the components of drug cartridge assembly 10. As discussed above, certain advantages may be had by fabricating drug cartridge 12 from glass, and the drug cartridge typically will be fabricated from that material. However, gamma radiation often will produce an orange or brown discoloration when used to sterilize glass. This can be undesirable, particularly where it is important that it be easy to view the contents of drug cartridge 12.
Thermal sterilization may also present certain problems, and typically is not preferred as a primary method for sterilizing medical devices made from plastic and other polymeric materials. Heat, for example, can melt components and/or cause other damage.
Accordingly, the method of preparing drug cartridge assembly 10 for use may include separate sterilization processes for different components. As shown in Fig. 3, a thermal sterilization process, such as dry heat sterilization process 60, may be employed to sterilize drug cartridge 12. Washing and/or rinsing of the cartridge may be performed before, during or after the thermal sterilization. Typically, a separate radiation-based process, such as gamma sterilization 62, is employed to sterilize nozzle sub-assembly 50 and plunger 26.
It is also typical to siliconize drug cartridge 12 prior to assembly. This is typically done by treating with 1% silicon emulsion, and then baking in a lehr until the glass temperature reaches 300 degrees Celsius for a period of 25 minutes +/- 5 minutes.
After sterilization occurring at 60 and 62, additional assembly and preparation may be performed within another cleanroom 70. Cleanroom 70 typically is used for final processing, and will therefore normally have a substantially lower particulate-per-volume classification than cleanroom 40. In the depicted method, for example, cleanroom 70 has a particulate concentration rating which is 1,000 times lower than that of cleanroom 40.
Separate cleanrooms may be employed, as in the depicted example, to minimize the amount of preparation occurring within the "cleaner" environments. Minimizing usage of the cleaner room saves on cost, as cleaner environments are often more expensive to use and maintain. However, it should be understood that not all implementations of the described method require use of cleanroom environments with differing classifications.
The assembly steps shown in cleanroom 40, for example, may instead be performed within cleanroom 70, or vice versa.
Drug cartridge 12, nozzle sub-assembly 50 and plunger 26 may be placed within cleanroom 70, typically after sterilization has been performed. Preparation within cleanroom 70 typically includes inserting drug cartridge 12 into nozzle 14, as indicated on the left side of cleanroom 70. The cartridge is positioned so that end 12a is firmly engaged with cartridge seal 16, as shown in Fig. L. At this point, cartridge end 12b is open and may receive liquid, as shown in the center of cleanroom 70.
Specifically, a quantity of liquid 20 (e.g., a metered does of an injectable drug) is dispensed from liquid supply 72 into cartridge 12. Plunger 26 may then be inserted into the open end of cartridge 12 to seal the liquid dose within the cartridge.
As shown at 74, drug cartridge assembly 10 may be further processed, for example, to prepare the product for shipping. Though reference number 74 denotes a process representation that is positioned outside of cleanroom 70, it should be appreciated that final processing tasks will often occur at least partly within cleanroom 70. The fully assembled drug cartridge assembly may, for example, be placed within a sterile bag while within cleanroom 70, with additional final preparation such as packaging, labeling, etc. being performed outside of the cleanroom.
Alternatively, final preparation may occur completely within or outside of cleanroom 70.
It should be understood that the described method may implemented in a wide variety of ways. For example, although Fig. 3 depicts only a single drug cartridge assembly, the described method often will be implemented on a larger scale to efficiently mass-produce drug cartridge assemblies in large numbers. According to one such implementation, plural cartridges 12 are disposed on a tray or like holding device, and remain on the tray during at least part of the manufacturing process. While on the tray, for example, the cartridges may be washed, depyrogenized, and subjected to other cleaning / sterilization processes (e.g., dry heat sterilization process 60).
Such a tray may also be used to facilitate the other processes described above, such as the steps performed within cleanroom 70.
It should also be understood that the various steps described above may be performed in any practicable order. The process arrows shown in Fig. 3 are intended only to illustrate a particular example, and should not be interpreted as requiring steps to be performed in a particular sequence. Cartridge 12 may, for example, be filled and sealed prior to positioning of the cartridge within nozzle 14. Gamma sterilization 62 may be performed prior to any assembly of the components to be irradiated. Such radiation is normally performed at a level of from 26 to 40 Krads, and is typically at between 32 and 34 Krads. Many other variations are possible.
Those skilled in the relevant arts will also appreciate that the methods described herein are generally applicable to sterile devices having multiple components or parts.
As discussed above, individual components or groups of components are separated based on the suitability of available sterilization techniques. In the above illustration, for example, glass components are separated from components made from plastic and other polymeric materials. The separated components are then sterilized separately using the appropriate sterilization method. Glass, for example, is thermally sterilized, and the polymeric components are sterilized via radiation.
The components are then assembled together to produce the final assembled device. Typically, this final step is conducted in a cleanroom with a relatively low particulate-per-volume classification. For many sterile devices, there will be a number of components that are made from the same material, and/or that may be sterilized using the same method. In such a case, it will often be appropriate to assemble these components together prior to sterilization. For example, in the above illustration, nozzle sub-assembly 50 is assembled from its component parts prior to gamma sterilization. Such pre-sterilization assembly will often be conducted within a cleanroom. Because of the subsequent sterilization, the cleanroom used for the pre-sterilization assembly may not need to have a particularly low particulate-per-volume rating. Indeed, in practice, the pre-sterilization cleanroom will often have a rating that is substantially higher (i.e., a "less clean" environment) than that of the cleanroom used for final assembly, in order to make cost-efficient use of cleanroom resources.
While the present invention has been particularly shown and described with reference to the foregoing preferred embodiments and implementations, those skilled in the art will understand that many variations may be made therein without departing from the spirit and scope of the invention as defined in the following claims. The description of the invention should be understood to include all novel and non-obvious combinations of elements described herein, and claims may be presented in this or a later application to any novel and non-obvious combination of these elements. Where the claims recite "a" or "a first" element or the equivalent thereof, such claims should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements.
Sterilization of the drug cartridge and nozzle sub-assembly may be performed separately, using different types of sterilization processes. Also, part of the method may be performed prior to sterilization within a first cleanroom, with subsequent steps being performed in a second cleanroom, where the second cleanroom has a substantially lower particulate-per-volume rating than the first cleanroom.
Some embodiments disclosed herein relate to a method of manufacturing a drug cartridge assembly, where the drug cartridge assembly includes a prefilled drug cartridge connected with a nozzle sub assembly that is configured to facilitate injection of liquid from the drug cartridge through an opening in the nozzle subassembly, the method comprising: preassembling the nozzle subassembly; sterilizing the preassembled nozzle subassembly with a radiation based sterilization process; sterilizing the drug cartridge with a separate, thermal based sterilization process; filling the drug cartridge; and disposing the drug cartridge in a readytouse position within the nozzle sub assembly, wherein the step of preassembling the nozzle sub assembly is performed within a first cleanroom, and where filling the drug cartridge and positioning the drug cartridge within the nozzle subassembly is performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
Some embodiments disclosed herein relate to a method of preparing a sterile drug cartridge assembly, comprising: providing a drug cartridge;
providing a nozzle subassembly, where the drug cartridge and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the drug cartridge out through the nozzle subassembly; assembling the nozzle subassembly and otherwise preparing the nozzle sub assembly for sterilization in a first cleanroom;
sterilizing the nozzle subassembly; sterilizing the drug cartridge; and positioning the drug cartridge in a ready to use position within the nozzle sub assembly, and filling and sealing the drug cartridge, where the positioning, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
Some embodiments disclosed herein relate to a method of manufacturing a sterile injection device, comprising: providing a liquid container;
providing a nozzle subassembly, where the liquid container and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the liquid container out through the nozzle subassembly; preparing the nozzle subassembly for sterilization, where such preparation is performed in a first cleanroom;
sterilizing the nozzle subassembly via irradiation; sterilizing the liquid container separately from the nozzle subassembly using a thermal sterilization process; and securing the liquid container and nozzle subassembly together, and filling and sealing the liquid container, where the securing, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
Brief Description of the Drawings Fig. 1 is a sectional view of a drug cartridge assembly.
Fig. 2 is an exploded view of the drug cartridge assembly of Fig. 1.
Fig. 3 is a schematic view depicting exemplary methods that may be used to assemble the drug cartridge assembly of Figs. 1 and 2, and prepare it for use in providing an injection.
3a Detailed Description of the Preferred Embodiment(s) The following description will address various implementations of a method of manufacture for a sterile device. The methods are widely applicable, though they are particularly advantageous where the device is to be constructed from multiple components or from more than one type of material, where certain sterilization processes pose problems relating to only a portion of the device, and/or where it is important that certain steps be carried out in cleanroom-type environment.
The methods described herein may, for example, be advantageously employed to prepare a variety of drug cartridge assemblies and other sterile medical devices.
For purposes of illustration only, the exemplary methods described herein will be discussed primarily in the context of a drug cartridge assembly. Further discussion and examples of drug cartridges and cartridge assemblies may be found in U.S. Patent No. 6,132,395, by Sergio Landau and James M. Bonicatto, entitled "Needleless Syringe With Prefilled Cartridge", which issued on October 17, 2000, and U.S. Patent No. 6,383,168, by Sergio Landau and James M. Bonicatto, entitled "Needleless Syringe with Prefilled Cartridge", which issued on May 7, 2002.
Figs. 1 and 2, respectively, depict a sectional view and an exploded view of a drug cartridge assembly 10. As shown, drug cartridge assembly 10 typically includes a liquid container, such as drug cartridge 12, and a nozzle 14. In the depicted example, nozzle 14 also serves as a housing for cartridge 12, as shown in Fig. 1, although a housing may be provided separately from nozzle 14, or may be omitted altogether. The depicted exemplary cartridge is formed as an open-ended cylinder, though other shapes and configurations may be employed, as desired.
A cartridge seal 16 may be provided at end 12a of cartridge 12, to maintain liquid 20 (e.g., a dose of drug) within cartridge 12 until it is to be ejected from drug cartridge assembly 10. Cartridge seal 16 may be implemented in a variety of ways, in order to maintain liquid 20 within cartridge 12 until the user desires to eject the liquid, for example, to administer an injection. As shown, cartridge seal 16 may be implemented as a ball-type check valve, including a ball 22 and a sealing member 24. Sealing member 24 may be secured with end 12a of cartridge 12, and includes a seat 24a. When ball 22 engages seat 24a, the end of the cartridge is sealed. A spring or other biasing member (not shown) may be provided to urge ball 22 upward into sealing engagement with seat 24a. Typically, a plunger 26 or like structure is provided to seal opposing end 12b of cartridge 12. As shown in Fig. 1, liquid 20 may thus be sealed within drug cartridge 12 by cartridge seal 16 and plunger 26.
Nozzle 14 typically includes an opening 14a through which liquid 20 from cartridge 12 may be ejected. Opening 14a may have any practicable dimensions, though it typically is narrower than the interior of cartridge 12. Use of a relatively narrow opening may facilitate high-pressure ejection of liquid 20, and enable injection of the liquid into a well-defined injection site. The end of nozzle 14 may be fitted with a removable cap 30 when drug cartridge assembly 10 is not being used, for example during shipping or storage.
As discussed above, nozzle 14 typically houses drug cartridge 12, though it will be appreciated that the nozzle 14 may take alternate forms. For example, nozzle 14 may be formed as a structure which is positioned on, or connected to, end 12a of cartridge 12, without wrapping around or otherwise enclosing the body of the cartridge.
Also, though cartridge seal 16 is a separate component in the depicted example, it should be appreciated that the seal may be formed integrally with nozzle 14 and/or cartridge 12.
The various components of drug cartridge assembly 10 may be made from a variety of different materials, including metals, plastics and other polymeric materials, ceramics, etc. Typically, in the depicted exemplary device, nozzle 14, cap 30, ball 22 and sealing member 24 are fabricated from plastic, or from another polymeric material.
Additionally, it will often be desirable to form sealing member 24 and/or ball 22 from an elastic, resilient material, such as rubber, in order to facilitate effective sealing.
Typically, use of polymeric materials as described above provides for cost-efficient manufacture and a durable device.
Though many components of drug cartridge assembly 10 can be advantageously formed from plastic, it will in many cases be preferable to manufacture drug cartridge 12 from glass, instead of from plastic or other materials. Use of thermoplastic containers, for example, may involve risks of interaction between the drug and the container. The drug may chemically react with the plastic, or may cause materials in the plastic to leach into the drug, thereby introducing impurities in the drug. In periods of extended storage, such exposure to a plastic container may result in degradation of the drug. In certain applications, glass may also be easier to clean and sterilize during initial preparation, and/or when being recycled for subsequent additional uses. It should be appreciated, however, that drug cartridge 12 may nonetheless be made from plastic or other materials other than glass.
It will often be desirable to provide drug cartridge assembly 10 to the end user as a pre-filled, ready-to-use assembly that has already been sterilized. The user would then simply need to remove cap 30 and operatively engage drug cartridge assembly 10 with an injection device (not shown), and then an injection could be administered. As shown in Fig. 2, threads 32 or another attachment mechanism may be provided to facilitate engagement of drug cartridge assembly 10 with an injection device. Typically, threads 32 are positioned on the outer surface of nozzle 14 opposite nozzle opening 14a.
An injection may be administered by forcing plunger 26 toward nozzle opening 14a (i.e., downward in Fig. 1) to apply pressure to liquid 20. Plunger 26 may be forced downward via movement of a plunger rod (not shown) or other structure brought into contact with plunger 26, through application of fluid pressure to plunger 26, or through other appropriate methods and structures. Upon application of sufficient pressure to the liquid supply, ball 22 is forced out of engagement with seat 24a and downward into a cavity 14b formed near the forward end of nozzle 14. When ball 22 is in this advanced state, liquid 20 from drug cartridge 12 can flow within cavity 14b around ball 22 and out through nozzle opening 14a.
When drug cartridge assembly 10 is provided in the ready-to-use configuration described above and shown in Fig. 1, the end user does not have to fill the injection device with a measured dose of injectable liquid, as is required with many existing injection devices. Filling adds an extra step, and can increase the risk of contaminating the liquid dose with air bubbles or other contaminants. Filling can also lead to spilling of the drug, and increases the risk that the user will come into undesired contact with the drug. In addition, a sterile adapter fitting is often required to couple the liquid container of the injection device with a source of injectable liquid. Accordingly, in most cases it will be desirable to implement drug cartridge assembly 10 in a pre-filled, ready-to-use state, as described.
Fig. 3 schematically depicts an exemplary method which may be used to prepare drug cartridge assembly 10. As will be explained, the method may include various assembly steps, it may be siliconized, and may be subjected to washing and other sterilization processes prior to packaging for shipment.
In many cases, it will be desirable to implement some or all of the method in a cleanroom or other controlled setting where airborne contamination is reduced from normal levels. For example, some preparation steps may be performed within cleanroom 40,.which, as shown, may be a class 10,000 cleanroom. Specifically, as shown in Fig. 3, cartridge seal 16 may be assembled within cleanroom 40 by inserting ball 22 into sealing member 24. Cartridge seal 16 is then positioned within the interior of nozzle 14, so that it generally covers nozzle opening 14a in a position that enables the cartridge seal to seal between open cartridge end 12a and nozzle opening 14a. Cap 30 may also be secured in place on the end of nozzle 14. The assembled components are designated at 50, and may be referred to collectively as the nozzle sub-assembly. Although the depicted nozzle sub-assembly is fabricated from a number of separate components, it should be understood that nozzle sub-assembly may be formed as a single unitary piece.
The term "cleanroom" as used herein should not be limited to an entire room, but might alternatively be a clean area, such as that defined under a laminar flow hood.
While nozzle sub-assembly 50 is still within cleanroom 40, nozzle sub-assembly 50 may be packed within a sterile container, such as double bag 52. As discussed below, the depicted exemplary method also includes radiation-based sterilization of nozzle sub-assembly 50. Accordingly, it will typically be preferred that the double bag 52 or other container used for nozzle sub-assembly 50 be suitable for exposure to radiation.
Alternatively, nozzle sub-assembly 50 may be removed from the initial packaging prior to radiation sterilization. It will often be preferable, however, to maintain nozzle sub-assembly 50 within the sterile packaging until final assembly of the nozzle sub-assembly with other components of drug cartridge assembly 10 (discussed below).
As discussed above, the components of drug cartridge assembly 10 may be fabricated from different materials. Sterilization and cleaning techniques that are suitable for one type of material may not be appropriate for another. Also, the particular way a component is used may affect what methods of cleaning and sterilization are most advantageous. Drug cartridge 12, for example, typically comes into direct contact with liquid (e.g., with a dose of an injectable drug). Accordingly, it will typically be desirable to wash and rinse drug cartridge 12 at some point during the preparation of cartridge assembly 10. Washing normally is performed during initial manufacture, and between uses where drug cartridge 12 is recycled for multiple uses. Although it is typical to wash cartridge 12, washing may not be appropriate or necessary for nozzle 14, or for the other components of drug cartridge assembly 10.
Similarly, radiation-based sterilization may not be suitable for all of the components of drug cartridge assembly 10. As discussed above, certain advantages may be had by fabricating drug cartridge 12 from glass, and the drug cartridge typically will be fabricated from that material. However, gamma radiation often will produce an orange or brown discoloration when used to sterilize glass. This can be undesirable, particularly where it is important that it be easy to view the contents of drug cartridge 12.
Thermal sterilization may also present certain problems, and typically is not preferred as a primary method for sterilizing medical devices made from plastic and other polymeric materials. Heat, for example, can melt components and/or cause other damage.
Accordingly, the method of preparing drug cartridge assembly 10 for use may include separate sterilization processes for different components. As shown in Fig. 3, a thermal sterilization process, such as dry heat sterilization process 60, may be employed to sterilize drug cartridge 12. Washing and/or rinsing of the cartridge may be performed before, during or after the thermal sterilization. Typically, a separate radiation-based process, such as gamma sterilization 62, is employed to sterilize nozzle sub-assembly 50 and plunger 26.
It is also typical to siliconize drug cartridge 12 prior to assembly. This is typically done by treating with 1% silicon emulsion, and then baking in a lehr until the glass temperature reaches 300 degrees Celsius for a period of 25 minutes +/- 5 minutes.
After sterilization occurring at 60 and 62, additional assembly and preparation may be performed within another cleanroom 70. Cleanroom 70 typically is used for final processing, and will therefore normally have a substantially lower particulate-per-volume classification than cleanroom 40. In the depicted method, for example, cleanroom 70 has a particulate concentration rating which is 1,000 times lower than that of cleanroom 40.
Separate cleanrooms may be employed, as in the depicted example, to minimize the amount of preparation occurring within the "cleaner" environments. Minimizing usage of the cleaner room saves on cost, as cleaner environments are often more expensive to use and maintain. However, it should be understood that not all implementations of the described method require use of cleanroom environments with differing classifications.
The assembly steps shown in cleanroom 40, for example, may instead be performed within cleanroom 70, or vice versa.
Drug cartridge 12, nozzle sub-assembly 50 and plunger 26 may be placed within cleanroom 70, typically after sterilization has been performed. Preparation within cleanroom 70 typically includes inserting drug cartridge 12 into nozzle 14, as indicated on the left side of cleanroom 70. The cartridge is positioned so that end 12a is firmly engaged with cartridge seal 16, as shown in Fig. L. At this point, cartridge end 12b is open and may receive liquid, as shown in the center of cleanroom 70.
Specifically, a quantity of liquid 20 (e.g., a metered does of an injectable drug) is dispensed from liquid supply 72 into cartridge 12. Plunger 26 may then be inserted into the open end of cartridge 12 to seal the liquid dose within the cartridge.
As shown at 74, drug cartridge assembly 10 may be further processed, for example, to prepare the product for shipping. Though reference number 74 denotes a process representation that is positioned outside of cleanroom 70, it should be appreciated that final processing tasks will often occur at least partly within cleanroom 70. The fully assembled drug cartridge assembly may, for example, be placed within a sterile bag while within cleanroom 70, with additional final preparation such as packaging, labeling, etc. being performed outside of the cleanroom.
Alternatively, final preparation may occur completely within or outside of cleanroom 70.
It should be understood that the described method may implemented in a wide variety of ways. For example, although Fig. 3 depicts only a single drug cartridge assembly, the described method often will be implemented on a larger scale to efficiently mass-produce drug cartridge assemblies in large numbers. According to one such implementation, plural cartridges 12 are disposed on a tray or like holding device, and remain on the tray during at least part of the manufacturing process. While on the tray, for example, the cartridges may be washed, depyrogenized, and subjected to other cleaning / sterilization processes (e.g., dry heat sterilization process 60).
Such a tray may also be used to facilitate the other processes described above, such as the steps performed within cleanroom 70.
It should also be understood that the various steps described above may be performed in any practicable order. The process arrows shown in Fig. 3 are intended only to illustrate a particular example, and should not be interpreted as requiring steps to be performed in a particular sequence. Cartridge 12 may, for example, be filled and sealed prior to positioning of the cartridge within nozzle 14. Gamma sterilization 62 may be performed prior to any assembly of the components to be irradiated. Such radiation is normally performed at a level of from 26 to 40 Krads, and is typically at between 32 and 34 Krads. Many other variations are possible.
Those skilled in the relevant arts will also appreciate that the methods described herein are generally applicable to sterile devices having multiple components or parts.
As discussed above, individual components or groups of components are separated based on the suitability of available sterilization techniques. In the above illustration, for example, glass components are separated from components made from plastic and other polymeric materials. The separated components are then sterilized separately using the appropriate sterilization method. Glass, for example, is thermally sterilized, and the polymeric components are sterilized via radiation.
The components are then assembled together to produce the final assembled device. Typically, this final step is conducted in a cleanroom with a relatively low particulate-per-volume classification. For many sterile devices, there will be a number of components that are made from the same material, and/or that may be sterilized using the same method. In such a case, it will often be appropriate to assemble these components together prior to sterilization. For example, in the above illustration, nozzle sub-assembly 50 is assembled from its component parts prior to gamma sterilization. Such pre-sterilization assembly will often be conducted within a cleanroom. Because of the subsequent sterilization, the cleanroom used for the pre-sterilization assembly may not need to have a particularly low particulate-per-volume rating. Indeed, in practice, the pre-sterilization cleanroom will often have a rating that is substantially higher (i.e., a "less clean" environment) than that of the cleanroom used for final assembly, in order to make cost-efficient use of cleanroom resources.
While the present invention has been particularly shown and described with reference to the foregoing preferred embodiments and implementations, those skilled in the art will understand that many variations may be made therein without departing from the spirit and scope of the invention as defined in the following claims. The description of the invention should be understood to include all novel and non-obvious combinations of elements described herein, and claims may be presented in this or a later application to any novel and non-obvious combination of these elements. Where the claims recite "a" or "a first" element or the equivalent thereof, such claims should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements.
Claims (15)
1. A method of manufacturing a drug cartridge assembly, where the drug cartridge assembly includes a prefilled drug cartridge connected with a nozzle sub assembly that is configured to facilitate injection of liquid from the drug cartridge through an opening in the nozzle subassembly, the method comprising:
preassembling the nozzle subassembly;
sterilizing the preassembled nozzle subassembly with a radiation based sterilization process; sterilizing the drug cartridge with a separate, thermal based sterilization process;
filling the drug cartridge; and disposing the drug cartridge in a readytouse position within the nozzle sub assembly, wherein the step of preassembling the nozzle sub assembly is performed within a first cleanroom, and where filling the drug cartridge and positioning the drug cartridge within the nozzle subassembly is performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
preassembling the nozzle subassembly;
sterilizing the preassembled nozzle subassembly with a radiation based sterilization process; sterilizing the drug cartridge with a separate, thermal based sterilization process;
filling the drug cartridge; and disposing the drug cartridge in a readytouse position within the nozzle sub assembly, wherein the step of preassembling the nozzle sub assembly is performed within a first cleanroom, and where filling the drug cartridge and positioning the drug cartridge within the nozzle subassembly is performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
2. The method of claim 1, where the first cleanroom is a class 10,000 cleanroom, and where the second cleanroom is a class 100 cleanroom.
3. A method of preparing a sterile drug cartridge assembly, comprising:
providing a drug cartridge;
providing a nozzle subassembly, where the drug cartridge and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the drug cartridge out through the nozzle subassembly;
assembling the nozzle subassembly and otherwise preparing the nozzle sub assembly for sterilization in a first cleanroom;
sterilizing the nozzle subassembly; sterilizing the drug cartridge; and positioning the drug cartridge in a ready to use position within the nozzle sub assembly, and filling and sealing the drug cartridge, where the positioning, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
providing a drug cartridge;
providing a nozzle subassembly, where the drug cartridge and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the drug cartridge out through the nozzle subassembly;
assembling the nozzle subassembly and otherwise preparing the nozzle sub assembly for sterilization in a first cleanroom;
sterilizing the nozzle subassembly; sterilizing the drug cartridge; and positioning the drug cartridge in a ready to use position within the nozzle sub assembly, and filling and sealing the drug cartridge, where the positioning, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
4. The method of claim 3, where preparing the nozzle subassembly includes providing a nozzle having a nozzle opening to accommodate ejection of liquid, and positioning a sealing mechanism adjacent the nozzle opening so that the sealing mechanism covers the nozzle opening.
5. The method of claim 3, where sterilizing the nozzle subassembly is performed with a radiation based sterilization process.
6. The method of claim 5, where sterilizing the nozzle subassembly is performed using gamma radiation.
7. The method of claim 5, where sterilizing the drug cartridge is performed with a thermal sterilization process, and is performed separately from sterilization of the nozzle subassembly.
8. The method of claim 3, where sterilization of the nozzle subassembly and drug cartridge are performed separately using different sterilization processes.
9. The method of claim 3, further comprising washing the drug cartridge.
10. The method of claim 3, further comprising depyrogenizing the drug cartridge.
11. The method of claim 3, further comprising siliconizing the drug cartridge.
12. The method of claim 3, where sealing the drug cartridge includes securing a valve structure between an opening in the nozzle subassembly and an opening in the drug cartridge.
13. The method of claim 12, where sealing the drug cartridge further includes disposing a plunger within another opening of the drug cartridge.
14. The method of claim 13, where the first cleanroom is a class 10,000 cleanroom and the second cleanroom is a class 100 cleanroom.
15. A method of manufacturing a sterile injection device, comprising:
providing a liquid container;
providing a nozzle subassembly, where the liquid container and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the liquid container out through the nozzle subassembly;
preparing the nozzle subassembly for sterilization, where such preparation is performed in a first cleanroom;
sterilizing the nozzle subassembly via irradiation;
sterilizing the liquid container separately from the nozzle subassembly using a thermal sterilization process; and securing the liquid container and nozzle subassembly together, and filling and sealing the liquid container, where the securing, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
providing a liquid container;
providing a nozzle subassembly, where the liquid container and nozzle subassembly are adapted to be engaged together to enable ejection of liquid from the liquid container out through the nozzle subassembly;
preparing the nozzle subassembly for sterilization, where such preparation is performed in a first cleanroom;
sterilizing the nozzle subassembly via irradiation;
sterilizing the liquid container separately from the nozzle subassembly using a thermal sterilization process; and securing the liquid container and nozzle subassembly together, and filling and sealing the liquid container, where the securing, filling and sealing are performed within a second cleanroom, the second cleanroom having a particulate per volume rating which is at least ten times lower than that of the first cleanroom.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/272,689 | 2002-10-16 | ||
US10/272,689 US6883222B2 (en) | 2002-10-16 | 2002-10-16 | Drug cartridge assembly and method of manufacture |
PCT/US2003/027192 WO2004035107A2 (en) | 2002-10-16 | 2003-08-28 | Drug cartridge assembly and method of manufacture |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2502888A1 CA2502888A1 (en) | 2004-04-29 |
CA2502888C true CA2502888C (en) | 2012-07-10 |
Family
ID=32092638
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2502888A Expired - Fee Related CA2502888C (en) | 2002-10-16 | 2003-08-28 | Drug cartridge assembly and method of manufacture |
Country Status (8)
Country | Link |
---|---|
US (1) | US6883222B2 (en) |
EP (1) | EP1551476B1 (en) |
JP (1) | JP2006502803A (en) |
AT (1) | ATE491545T1 (en) |
AU (1) | AU2003273259A1 (en) |
CA (1) | CA2502888C (en) |
DE (1) | DE60335395D1 (en) |
WO (1) | WO2004035107A2 (en) |
Families Citing this family (64)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7331944B2 (en) * | 2000-10-23 | 2008-02-19 | Medical Instill Technologies, Inc. | Ophthalmic dispenser and associated method |
CN101091678B (en) * | 2000-10-23 | 2011-03-30 | 因斯蒂尔医学技术有限公司 | Fluid dispenser having a housing and flexible inner bladder |
GB0100756D0 (en) | 2001-01-11 | 2001-02-21 | Powderject Res Ltd | Needleless syringe |
US7798185B2 (en) | 2005-08-01 | 2010-09-21 | Medical Instill Technologies, Inc. | Dispenser and method for storing and dispensing sterile food product |
JP4866005B2 (en) | 2002-08-13 | 2012-02-01 | メディカル・インスティル・テクノロジーズ・インコーポレイテッド | Container for storing and discharging contents and method related thereto |
US6997219B2 (en) | 2003-05-12 | 2006-02-14 | Medical Instill Technologies, Inc. | Dispenser and apparatus and method for filling a dispenser |
US7226231B2 (en) | 2003-07-17 | 2007-06-05 | Medical Instill Technologies, Inc. | Piston-type dispenser with one-way valve for storing and dispensing metered amounts of substances |
US20060100581A1 (en) * | 2004-08-13 | 2006-05-11 | Mogensen Lasse W | Reservoir for front end loaded infusion device |
US11590286B2 (en) | 2004-11-22 | 2023-02-28 | Kaleo, Inc. | Devices, systems and methods for medicament delivery |
US7648482B2 (en) | 2004-11-22 | 2010-01-19 | Intelliject, Inc. | Devices, systems, and methods for medicament delivery |
GB2453069B (en) | 2004-11-22 | 2009-12-09 | Intelliject Llc | Devices,systems and methods for medicament delivery |
US7648483B2 (en) | 2004-11-22 | 2010-01-19 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
US7947017B2 (en) * | 2004-11-22 | 2011-05-24 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
US10737028B2 (en) | 2004-11-22 | 2020-08-11 | Kaleo, Inc. | Devices, systems and methods for medicament delivery |
US7810677B2 (en) * | 2004-12-04 | 2010-10-12 | Medical Instill Technologies, Inc. | One-way valve and apparatus and method of using the valve |
CA2589888C (en) * | 2004-12-04 | 2013-02-26 | Medical Instill Technologies, Inc. | One-way valve, apparatus and method of using the valve |
US7731686B2 (en) * | 2005-02-01 | 2010-06-08 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
US8231573B2 (en) | 2005-02-01 | 2012-07-31 | Intelliject, Inc. | Medicament delivery device having an electronic circuit system |
US8361026B2 (en) | 2005-02-01 | 2013-01-29 | Intelliject, Inc. | Apparatus and methods for self-administration of vaccines and other medicaments |
US8206360B2 (en) | 2005-02-01 | 2012-06-26 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
US9022980B2 (en) | 2005-02-01 | 2015-05-05 | Kaleo, Inc. | Medical injector simulation device |
EP1843812A4 (en) * | 2005-02-01 | 2008-12-03 | Intelliject Llc | Devices, systems, and methods for medicament delivery |
US20070111196A1 (en) * | 2005-08-19 | 2007-05-17 | Javier Alarcon | Sterilization of Biosensors |
JP5036730B2 (en) * | 2006-01-31 | 2012-09-26 | ノボ・ノルデイスク・エー/エス | Pre-filled medical jet injection device seal |
US20070202186A1 (en) | 2006-02-22 | 2007-08-30 | Iscience Interventional Corporation | Apparatus and formulations for suprachoroidal drug delivery |
US8197435B2 (en) | 2006-05-02 | 2012-06-12 | Emory University | Methods and devices for drug delivery to ocular tissue using microneedle |
US20080083788A1 (en) * | 2006-09-08 | 2008-04-10 | Daniel Py | Apparatus for sealing and engaging sterile chambers |
US7547293B2 (en) * | 2006-10-06 | 2009-06-16 | Bioject, Inc. | Triggering mechanism for needle-free injector |
WO2008103997A2 (en) * | 2007-02-23 | 2008-08-28 | Bioject Inc. | Needle-free injection devices and drug delivery systems therefor |
GB0708758D0 (en) | 2007-05-04 | 2007-06-13 | Powderject Res Ltd | Particle cassettes and process thereof |
USD994111S1 (en) | 2008-05-12 | 2023-08-01 | Kaleo, Inc. | Medicament delivery device cover |
KR101682874B1 (en) * | 2009-06-30 | 2016-12-06 | 쿠리타 고교 가부시키가이샤 | Ion-exchange device, process and equipment for producing same, and method and device for forming ion-exchange resin layer |
JP5391874B2 (en) * | 2009-06-30 | 2014-01-15 | 栗田工業株式会社 | Manufacturing method of ion exchanger |
BR112012028538A2 (en) | 2010-05-07 | 2016-07-26 | Alps Llc | dispensing machine valve and method |
WO2012025549A1 (en) * | 2010-08-27 | 2012-03-01 | Sanofi-Aventis Deutschland Gmbh | Packaging system for multi-component medical products |
US9173999B2 (en) | 2011-01-26 | 2015-11-03 | Kaleo, Inc. | Devices and methods for delivering medicaments from a multi-chamber container |
US8627816B2 (en) | 2011-02-28 | 2014-01-14 | Intelliject, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
US8939943B2 (en) | 2011-01-26 | 2015-01-27 | Kaleo, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
DE102011013792A1 (en) * | 2011-03-03 | 2012-09-06 | Vetter Pharma-Fertigung GmbH & Co. KG | Closure for a powder syringe and powder syringe |
IL308846A (en) | 2011-10-14 | 2024-01-01 | Amgen Inc | Injector and method of assembly |
CN104470559B (en) * | 2012-03-12 | 2018-02-06 | 尤尼特拉克特注射器控股有限公司 | Stuffing box for sterile fluid path component and the delivery device comprising stuffing box |
US9522235B2 (en) | 2012-05-22 | 2016-12-20 | Kaleo, Inc. | Devices and methods for delivering medicaments from a multi-chamber container |
JP2015521515A (en) * | 2012-07-02 | 2015-07-30 | ノボ ノルディスク ヘルス ケア アーゲー | Method for manufacturing a medical device |
US20140114248A1 (en) * | 2012-10-24 | 2014-04-24 | Nuance Designs, LLC | Power pack for an autoinjector |
JP6487848B2 (en) | 2012-11-08 | 2019-03-20 | クリアサイド バイオメディカル,インコーポレイテッド | Methods and devices for the treatment of ocular disorders in human subjects |
ES2853748T3 (en) | 2013-03-22 | 2021-09-17 | Amgen Inc | Injector and mounting method |
BR112015027762A2 (en) | 2013-05-03 | 2017-08-29 | Clearside Biomedical Inc | APPLIANCE AND METHODS FOR OCULAR INJECTION |
WO2014197317A1 (en) | 2013-06-03 | 2014-12-11 | Clearside Biomedical, Inc. | Apparatus and methods for drug delivery using multiple reservoirs |
ES2744837T3 (en) | 2013-10-24 | 2020-02-26 | Amgen Inc | Injector and assembly procedure |
JP2017524419A (en) | 2014-06-20 | 2017-08-31 | クリアサイド バイオメディカル,インコーポレイテッド | Variable diameter cannula and method for controlling insertion depth for drug delivery |
US9646730B2 (en) * | 2014-07-18 | 2017-05-09 | Nuclear Diagnostic Products Inc. | Ultra clean cleaning process for radiopharmaceutical reusable pigs |
US9517307B2 (en) | 2014-07-18 | 2016-12-13 | Kaleo, Inc. | Devices and methods for delivering opioid antagonists including formulations for naloxone |
USD750223S1 (en) | 2014-10-14 | 2016-02-23 | Clearside Biomedical, Inc. | Medical injector for ocular injection |
EP3274021B1 (en) | 2015-03-24 | 2024-02-14 | Kaleo, Inc. | Devices and methods for delivering a lyophilized medicament |
FR3036968A1 (en) | 2015-06-02 | 2016-12-09 | Biocorp Prod | BOX FOR MOUNTING A CONTAINER ON AN INJECTOR PEN, AN INJECTABLE PRODUCT TANK ASSEMBLY FOR AN INJECTOR PEN AND AN INJECTOR PEN EQUIPPED WITH SUCH AN ASSEMBLY |
FR3036969A1 (en) * | 2015-06-02 | 2016-12-09 | Biocorp Prod | PROCESS FOR MANUFACTURING AT LEAST ONE TANK ASSEMBLY, INJECTABLE PRODUCT TANK ASSEMBLY FOR INJECTOR PEN AND INJECTOR PEN EQUIPPED WITH SUCH ASSEMBLY |
WO2017004345A1 (en) | 2015-06-30 | 2017-01-05 | Kaleo, Inc. | Auto-injectors for administration of a medicament within a prefilled syringe |
WO2017139375A1 (en) | 2016-02-10 | 2017-08-17 | Clearside Biomedical, Inc. | Ocular injection kit, packaging, and methods of use |
WO2017192565A1 (en) | 2016-05-02 | 2017-11-09 | Clearside Biomedical, Inc. | Systems and methods for ocular drug delivery |
US10973681B2 (en) | 2016-08-12 | 2021-04-13 | Clearside Biomedical, Inc. | Devices and methods for adjusting the insertion depth of a needle for medicament delivery |
US10688244B2 (en) | 2016-12-23 | 2020-06-23 | Kaleo, Inc. | Medicament delivery device and methods for delivering drugs to infants and children |
FR3078489A1 (en) * | 2018-03-01 | 2019-09-06 | L'oreal | CARTRIDGE FOR INJECTION DEVICE WITHOUT NEEDLE |
WO2021030210A1 (en) | 2019-08-09 | 2021-02-18 | Kaleo, Inc. | Devices and methods for delivery of substances within a prefilled syringe |
TW202302167A (en) * | 2021-04-30 | 2023-01-16 | 日商大成化工股份有限公司 | Syringe |
Family Cites Families (56)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3102151A (en) * | 1958-06-13 | 1963-08-27 | American Cyanamid Co | Process for the dealkylation of alkyl naphthalene |
US3057349A (en) * | 1959-12-14 | 1962-10-09 | Ismach Aaron | Multi-dose jet injection device |
US3115133A (en) * | 1962-05-15 | 1963-12-24 | Morando Emilio Donald | Needleless prefilled disposable hypodermic injector |
US3202151A (en) | 1963-04-08 | 1965-08-24 | Scherer Corp R P | Multidose jet injector |
US3292621A (en) * | 1963-07-19 | 1966-12-20 | Oscar H Banker | Jet type protable inoculator |
US3425413A (en) * | 1965-04-30 | 1969-02-04 | Amalgamated Dental Co Ltd | Multi-dosage jet injector |
US3507276A (en) * | 1968-08-28 | 1970-04-21 | Murray B Burgess | Jet injector |
US3561443A (en) * | 1968-09-06 | 1971-02-09 | Oscar H Banker | Inoculator gun with delayed action |
DE1802529A1 (en) * | 1968-10-11 | 1970-05-21 | Pfizer Gmbh | Disposable hypodermic syringe |
US3688765A (en) * | 1969-10-03 | 1972-09-05 | Jack S Gasaway | Hypodermic injection device |
US3714943A (en) * | 1970-12-01 | 1973-02-06 | H Yanof | Medicament injectors |
US3788315A (en) | 1971-04-20 | 1974-01-29 | S Laurens | Disposable cutaneous transjector |
GB1345290A (en) * | 1971-12-23 | 1974-01-30 | Dunlop Ltd | Inflatable seals |
US3908651A (en) | 1974-05-17 | 1975-09-30 | Daystrol Scient Inc | Medicament injection device |
US3945379A (en) * | 1974-08-08 | 1976-03-23 | Smithkline Corporation | Injection device |
US4124024A (en) * | 1977-03-03 | 1978-11-07 | Schwebel Paul R | Disposable hypodermic injection ampule |
BR7806153A (en) * | 1978-09-19 | 1980-04-01 | Halen Elliot Brasil Ind Com Eq | HYPODERMIC PRESSURE INJECTOR FOR INTERMITTENT VACCINATION |
US4342310A (en) * | 1980-07-08 | 1982-08-03 | Istvan Lindmayer | Hydro-pneumatic jet injector |
USD277506S (en) * | 1981-09-15 | 1985-02-05 | Bearn Mecanique Aviation S.A. | Needle-less injection instrument |
CA1178503A (en) * | 1982-05-27 | 1984-11-27 | Health-Mor Personal Care Corporation | Needleless hypodermic injector |
BR8404286A (en) * | 1984-08-28 | 1986-04-08 | Sergio Landau | PRESSURE HYPODERMIC SYRINGE |
US4596556A (en) * | 1985-03-25 | 1986-06-24 | Bioject, Inc. | Hypodermic injection apparatus |
US4680027A (en) * | 1985-12-12 | 1987-07-14 | Injet Medical Products, Inc. | Needleless hypodermic injection device |
US4717384A (en) * | 1987-01-15 | 1988-01-05 | Pneu Dart Inc. | Pneumatic hypodermic syringe pole |
EP0294272B1 (en) * | 1987-05-26 | 1992-03-18 | Claude Accaries | Needleless injector, especially for dental use |
US4941880A (en) * | 1987-06-19 | 1990-07-17 | Bioject, Inc. | Pre-filled ampule and non-invasive hypodermic injection device assembly |
US4940460A (en) * | 1987-06-19 | 1990-07-10 | Bioject, Inc. | Patient-fillable and non-invasive hypodermic injection device assembly |
US4790824A (en) * | 1987-06-19 | 1988-12-13 | Bioject, Inc. | Non-invasive hypodermic injection device |
US5554125A (en) * | 1987-07-08 | 1996-09-10 | Reynolds; David L. | Prefilled vial syringe |
AU628029B2 (en) * | 1987-11-16 | 1992-09-10 | Sy-Quest International Limited | Improved apparatus for hypodermic injection of liquids |
BR8801952A (en) * | 1988-04-22 | 1989-11-14 | Sergio Landau | DISPOSABLE CAPSULE, NOT RE-USABLE, CONTAINING INDIVIDUAL DOSE OF VACCINE TO BE HYPODERMICALLY INJECTED, WITHOUT NEEDLE, WITH PRESSURE INJECTOR |
US5024656A (en) * | 1988-08-30 | 1991-06-18 | Injet Medical Products, Inc. | Gas-pressure-regulated needleless injection system |
US5009654A (en) * | 1989-03-10 | 1991-04-23 | Baxter International Inc. | Sterile product and method for sterilizing and assembling such product |
US5064413A (en) * | 1989-11-09 | 1991-11-12 | Bioject, Inc. | Needleless hypodermic injection device |
US5312335A (en) * | 1989-11-09 | 1994-05-17 | Bioject Inc. | Needleless hypodermic injection device |
USD349958S (en) * | 1992-07-24 | 1994-08-23 | Bioject Inc. | Needleless injector |
US5383851A (en) * | 1992-07-24 | 1995-01-24 | Bioject Inc. | Needleless hypodermic injection device |
US5334144A (en) * | 1992-10-30 | 1994-08-02 | Becton, Dickinson And Company | Single use disposable needleless injector |
US5891086A (en) * | 1993-07-31 | 1999-04-06 | Weston Medical Limited | Needle-less injector |
US5505697A (en) * | 1994-01-14 | 1996-04-09 | Mckinnon, Jr.; Charles N. | Electrically powered jet injector |
FR2718357B1 (en) * | 1994-04-06 | 1997-10-03 | Defarges Alain Moreau | Improvements made to a needleless jet injection device. |
US5899880A (en) * | 1994-04-08 | 1999-05-04 | Powderject Research Limited | Needleless syringe using supersonic gas flow for particle delivery |
US5597530A (en) * | 1994-08-18 | 1997-01-28 | Abbott Laboratories | Process for prefilling and terminally sterilizing syringes |
DE19652708C2 (en) * | 1996-12-18 | 1999-08-12 | Schott Glas | Process for producing a filled plastic syringe body for medical purposes |
JPH10277153A (en) * | 1997-04-04 | 1998-10-20 | Asahi Chem Ind Co Ltd | Injection unit filled with medicine |
US5993412A (en) * | 1997-05-19 | 1999-11-30 | Bioject, Inc. | Injection apparatus |
JP2003514587A (en) * | 1997-07-14 | 2003-04-22 | ノボ ノルディスク アクティーゼルスカブ | Injection parts |
US6004287A (en) * | 1997-09-23 | 1999-12-21 | Loomis; Dale J | Biolistic apparatus for delivering substances into cells and tissues |
EP1061974A1 (en) * | 1998-03-13 | 2000-12-27 | Becton, Dickinson and Company | Method for manufacturing, filling and packaging medical containers |
US6096002A (en) * | 1998-11-18 | 2000-08-01 | Bioject, Inc. | NGAS powered self-resetting needle-less hypodermic jet injection apparatus and method |
US6264629B1 (en) * | 1998-11-18 | 2001-07-24 | Bioject, Inc. | Single-use needle-less hypodermic jet injection apparatus and method |
US6132395A (en) * | 1998-12-08 | 2000-10-17 | Bioject, Inc. | Needleless syringe with prefilled cartridge |
US6383168B1 (en) | 1998-12-08 | 2002-05-07 | Bioject Medical Technologies Inc. | Needleless syringe with prefilled cartridge |
US6224567B1 (en) * | 1999-09-08 | 2001-05-01 | Cambridge Biostability Limited | Modified disposable injector device |
US6210359B1 (en) * | 2000-01-21 | 2001-04-03 | Jet Medica, L.L.C. | Needleless syringe |
MXPA03008316A (en) * | 2001-03-14 | 2004-09-10 | Penjet Corp | System and method for removing dissolved gas from a solution. |
-
2002
- 2002-10-16 US US10/272,689 patent/US6883222B2/en not_active Expired - Lifetime
-
2003
- 2003-08-28 JP JP2004545256A patent/JP2006502803A/en active Pending
- 2003-08-28 WO PCT/US2003/027192 patent/WO2004035107A2/en active Application Filing
- 2003-08-28 AU AU2003273259A patent/AU2003273259A1/en not_active Abandoned
- 2003-08-28 DE DE60335395T patent/DE60335395D1/en not_active Expired - Lifetime
- 2003-08-28 AT AT03755762T patent/ATE491545T1/en not_active IP Right Cessation
- 2003-08-28 EP EP03755762A patent/EP1551476B1/en not_active Expired - Lifetime
- 2003-08-28 CA CA2502888A patent/CA2502888C/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
ATE491545T1 (en) | 2011-01-15 |
US20040074076A1 (en) | 2004-04-22 |
JP2006502803A (en) | 2006-01-26 |
AU2003273259A1 (en) | 2004-05-04 |
EP1551476A4 (en) | 2007-06-27 |
AU2003273259A8 (en) | 2004-05-04 |
WO2004035107A3 (en) | 2004-06-17 |
WO2004035107A2 (en) | 2004-04-29 |
EP1551476B1 (en) | 2010-12-15 |
US6883222B2 (en) | 2005-04-26 |
EP1551476A2 (en) | 2005-07-13 |
CA2502888A1 (en) | 2004-04-29 |
DE60335395D1 (en) | 2011-01-27 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CA2502888C (en) | Drug cartridge assembly and method of manufacture | |
US6065270A (en) | Method of producing a filled plastic syringe body for medical purposes | |
US10751252B2 (en) | Adaptor for coupling with a medical container | |
US5597530A (en) | Process for prefilling and terminally sterilizing syringes | |
US8679068B2 (en) | Pre-filled syringe including an oxygen absorber | |
JP4216467B2 (en) | Medical device assembly and packaging method | |
EP0555900B1 (en) | Pre-filled plastic syringes, containers and vials and method of terminal sterilization thereof | |
JPH08504353A (en) | Manufacturing method and manufacturing device for pre-filled sterilizing and discharging device | |
JP6456978B2 (en) | Medical injection device having a cleaning reservoir | |
WO2013115730A1 (en) | Adaptor with injection device for coupling to a medical container | |
ES2358102T3 (en) | CARTRIDGE ASSEMBLY FOR MEDICINES AND MANUFACTURING PROCEDURE. | |
JP2007209675A (en) | Manufacturing method of prefilled syringe | |
EP2692324A1 (en) | Adaptor for coupling with a medical container | |
JP7411543B2 (en) | Prefilled syringes and how to prepare them | |
WO2019063785A1 (en) | Prefilled syringe and method of preparing a prefilled syringe | |
OA17626A (en) | Adaptor for coupling with a medical container | |
JPH07303683A (en) | Transfusion container and its manufacture |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
MKLA | Lapsed |
Effective date: 20160829 |