WO2012007056A1 - Manufacturing process for packing of injectables - Google Patents

Manufacturing process for packing of injectables Download PDF

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Publication number
WO2012007056A1
WO2012007056A1 PCT/EP2010/060332 EP2010060332W WO2012007056A1 WO 2012007056 A1 WO2012007056 A1 WO 2012007056A1 EP 2010060332 W EP2010060332 W EP 2010060332W WO 2012007056 A1 WO2012007056 A1 WO 2012007056A1
Authority
WO
WIPO (PCT)
Prior art keywords
devices
manufacturing process
secondary container
assembled
assembled devices
Prior art date
Application number
PCT/EP2010/060332
Other languages
French (fr)
Inventor
Fabiano Nicoletti
Original Assignee
Stevanato Group International A.S.
Safety Syringes Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stevanato Group International A.S., Safety Syringes Inc. filed Critical Stevanato Group International A.S.
Priority to EP10734485.5A priority Critical patent/EP2593369A1/en
Priority to PCT/EP2010/060332 priority patent/WO2012007056A1/en
Priority to MX2013000382A priority patent/MX2013000382A/en
Priority to CA2804814A priority patent/CA2804814C/en
Priority to JP2013518961A priority patent/JP2013534195A/en
Priority to BR112013001033A priority patent/BR112013001033A2/en
Priority to US13/809,620 priority patent/US20140223862A1/en
Priority to CN2010800679578A priority patent/CN103118945A/en
Publication of WO2012007056A1 publication Critical patent/WO2012007056A1/en

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/04Packaging single articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles

Definitions

  • the present invention relates to a manufacturing process for packaging of injectables for medical use .
  • Standard manufacturing processes for packing of injectables of the present art generally involve the following sequence of steps: washing, secondary packaging suitable for sterilisation, sterilisation, filling, stoppering, and final secondary packing of a primary container for the substance to be injected.
  • the filled primary container must be visually and/or functionally inspected to ensure that its shape and content meet the required cosmetic and functional requirements. This inspection is often compulsory in the pharmaceutical industry for regulatory purposes and is generally carried out either by way of automated systems involving cameras and corresponding software, or by operators or inspectors.
  • US6263641, US6792743, US6189292 and US2006/0054523 describe manufacturing processes for packing of injectables for medical use wherein an additional device, such as a safety device, is assembled onto the primary container after the filling and stoppering and outside a sterile environment.
  • an additional device such as a safety device
  • the primary container is provided with a complementary device, such as where the primary container is a syringe and the complementary device is a system of preventing injuries from the bare needle tip after injection
  • the visual inspection must be performed both after the stoppering step and after the assembly step. This repeated checking increases the time requirement, complexity and cost of the manufacturing process.
  • the technical task of the present invention is therefore that of providing a manufacturing process for packing of injectables that overcomes the noted technical drawbacks of the prior art. Within the scope of this technical task is therefore that of providing a manufacturing process for packing of injectables with increased productivity. A further object of the invention is that of providing a simple, cost-effective manufacturing process for packing of injectables while maintaining health and safety standards.
  • the process comprises, after the step of assembling the empty primary containers with corresponding complementary devices, a step of filling and stoppering said primary containers of said assembled devices.
  • the step of assembling the empty primary containers with corresponding complementary devices being before filling and stoppering negates the need for inspection after the assembly step. This in turn eliminates the time requirement and cost associated with the second check, thereby increasing productivity. Moreover, the lack of a second check simplifies the process, thereby simplifying operation and rendering the process more cost-effective while maintaining health and safety standards.
  • the present invention furthermore allows for the same number and type of operations to be performed inside the sterile environment as in the present art, namely transferring, positioning, filling and stoppering.
  • the cost of adapting the processes of the prior art so as to incorporate the present invention is thus not excessive.
  • the manufacturing process of the present invention does not lead to any higher potential level of contamination of the sterile environment than the processes of the prior art.
  • contamination may include a low particles content, low bio-burden and limited ethylene oxide residual after sterilisation.
  • Figure 2 shows a process flow diagram of the prior Figure 3 shows an exploded view of an assembled device nested in a tray, filled and stoppered, according to one embodiment of the invention.
  • Figure 4 shows a perspective view of one embodiment of an assembled device, filled and stoppered, according to the embodiment of the invention of figure 3.
  • Figure 5 shows a front view of the assembled device, filled and stoppered, of figure 4.
  • the invention comprises a sequence of subsequent steps commencing with the manufacture of primary containers.
  • the manufacturing process of one embodiment of the invention comprises the following steps:
  • manuf cturing processes of the prior art generally comprise the following steps:
  • the primary containers may optionally be syringes or glass containers, pre-fillable with drugs for medical use, and may be formed (1) by a glass-forming device. Any plastic parts, such as complementary devices, may be formed by injection moulding (3) . After manufacture, the empty primary containers are assembled (5) with corresponding complementary devices to yield assembled devices (6) .
  • the primary containers comprise pre-fillable glass syringes (2).
  • the corresponding complementary devices (4) are safety devices (24) for preventing injury from the bare needle tips of the syringes after injection as well as, optionally, rigid needle shields (25) for preventing injury before inj ection.
  • the empty primary containers assembled with the complementary devices must be washed (7), preferably using water for injection.
  • the assembled devices are then transferred into a sterile environment by means of packing them in a secondary container.
  • the secondary container preferably comprises a tray (9) with a plurality of seats into which the assembled devices (6) can be nested such that they are held in a precise position and are held fixedly during transport. This facilitates correct positioning in the x-y plane for accurate filling and stoppering of the devices ( 6 ⁇ .
  • the tray (9), which is preferably made of a rigid or semi-rigid plastic material and contains the nested assembled devices (6), is then preferably inserted into a tub of the secondary container.
  • This tub is also preferably made of rigid or semirigid plastic and preferably has a transparent section to allow inspection of the contents thereof, in particular the assembled devices.
  • the nest-and-tub design of the secondary packaging is suitable for keeping the assembled devices (6) separate from one another, thereby preventing scratches or other damage.
  • a peelable sheet of the secondary packaging is applied to the peripheral edge of the tub in order to close the secondary container and seal the assembled devices within the secondary container.
  • the tub is preferably not permeable, whereas the sheet is preferably made of a selectively impervious material that prevents contamination of the assembled devices by micro-organisms, bacteria and/or biologically active materials while remaining permeable to a sterilisation agent such as ethylene oxide gas.
  • the closed secondary container and its contents are subsequently sterilised (10) and prepared for transfer to a remote site where the remaining steps can be carried out.
  • the primary containers of the assembled devices (6) are filled (11) with the desired substance, such as drugs for medical use, and stoppered in the sterile environment.
  • the stoppering comprises , insertion of plungers (23) thereinto.
  • the assembled devices (6) in the sterile environment are visually and/or functionally inspected (12). This can preferably be done either by operators or inspectors and/or by automated systems having one or more cameras and corresponding software.
  • the inspection may check, among other, the colour, amount and other properties of the filled substance, the shape, aesthetics and functional aspects of the primary containers, presence and correct positioning of the stoppers, functionality of moving any parts, and the correct appearance and assembly of the complementary devices (4).
  • the transparent section of the complementary devices (4) allows of the filled primary containers (2) inside the complementary devices (4) .
  • the process may optionally comprise a further step of final packing (13) of the inspected assembled devices (6) .
  • the secondary container and/or the final packaging preferably comprise information for identification and traceability of the contents, such as an RFID system.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Diabetes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Basic Packing Technique (AREA)
  • Paper (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Moulds For Moulding Plastics Or The Like (AREA)

Abstract

The manufacturing process for packing of injectables for medical use, comprises in temporal sequence the steps of: a} forming (1) of glass primary containers, b) forming by plastic injection (3) of complementary devices (4), c) assembling (5) of the empty primary containers with corresponding complementary devices to form assembled devices (6), d) washing (7) the assembled devices with water for injection, e) nesting (8) the assembled devices in a tray (9), f} inserting said tray housing said assembled devices into a secondary container and closing said secondary container, g) sterilising (10) the assembled devices in the closed secondary container, h) preparing the closed secondary container for transportation to a remote site.

Description

MANUFACTURING PROCESS FOR PACKING OF I JECTABLES
DESCRIPTION
The present invention relates to a manufacturing process for packaging of injectables for medical use .
Standard manufacturing processes for packing of injectables of the present art generally involve the following sequence of steps: washing, secondary packaging suitable for sterilisation, sterilisation, filling, stoppering, and final secondary packing of a primary container for the substance to be injected. Importantly, before the final secondary packing takes place, the filled primary container must be visually and/or functionally inspected to ensure that its shape and content meet the required cosmetic and functional requirements. This inspection is often compulsory in the pharmaceutical industry for regulatory purposes and is generally carried out either by way of automated systems involving cameras and corresponding software, or by operators or inspectors.
US6263641, US6792743, US6189292 and US2006/0054523 describe manufacturing processes for packing of injectables for medical use wherein an additional device, such as a safety device, is assembled onto the primary container after the filling and stoppering and outside a sterile environment.
However, where the primary container is provided with a complementary device, such as where the primary container is a syringe and the complementary device is a system of preventing injuries from the bare needle tip after injection, the visual inspection must be performed both after the stoppering step and after the assembly step. This repeated checking increases the time requirement, complexity and cost of the manufacturing process.
The technical task of the present invention is therefore that of providing a manufacturing process for packing of injectables that overcomes the noted technical drawbacks of the prior art. Within the scope of this technical task is therefore that of providing a manufacturing process for packing of injectables with increased productivity. A further object of the invention is that of providing a simple, cost-effective manufacturing process for packing of injectables while maintaining health and safety standards.
The technical task, as well as these and other objects of the invention, are achieved according to the present invention by a manufacturing process for packing of injectables for medical use, characterised in that it comprises in temporal sequence the steps of:
a) forming (1) of glass primary containers, b) forming by plastic injection (3) of complementary devices (4),
c) assembling (5) of the empty primary containers with corresponding complementary devices to form assembled devices (6),
d} washing (7) the assembled devices with water for injection,
e) nesting (8) the assembled devices in a tray { 9) ,
f) inserting said tray housing said assembled devices into a secondary container and closing said secondary container, sterilising (10) the assembled devices in the closed secondary container,
preparing the closed secondary container for transportation to a remote site.
Preferably the process comprises, after the step of assembling the empty primary containers with corresponding complementary devices, a step of filling and stoppering said primary containers of said assembled devices.
The step of assembling the empty primary containers with corresponding complementary devices being before filling and stoppering negates the need for inspection after the assembly step. This in turn eliminates the time requirement and cost associated with the second check, thereby increasing productivity. Moreover, the lack of a second check simplifies the process, thereby simplifying operation and rendering the process more cost-effective while maintaining health and safety standards.
The present invention furthermore allows for the same number and type of operations to be performed inside the sterile environment as in the present art, namely transferring, positioning, filling and stoppering. The cost of adapting the processes of the prior art so as to incorporate the present invention is thus not excessive.
In addition, the manufacturing process of the present invention does not lead to any higher potential level of contamination of the sterile environment than the processes of the prior art. Such contamination may include a low particles content, low bio-burden and limited ethylene oxide residual after sterilisation.
Other characteristics of the present invention are moreover defined in the subsequent claims. Further characteristics and advantages of the present invention will be more evident from the description of a preferred, but not exclusive, embodiment of the manufacturing process for packing of injectables according to the finding, illustrated in the attached, non-limiting drawings, wherein:
Figure 1 shows a process flow diagram of one embodiment of the present invention.
Figure 2 shows a process flow diagram of the prior Figure 3 shows an exploded view of an assembled device nested in a tray, filled and stoppered, according to one embodiment of the invention.
Figure 4 shows a perspective view of one embodiment of an assembled device, filled and stoppered, according to the embodiment of the invention of figure 3.
Figure 5 shows a front view of the assembled device, filled and stoppered, of figure 4.
Reference numbers refer to equivalent features in each of the figures.
With reference to the above figures, the invention comprises a sequence of subsequent steps commencing with the manufacture of primary containers. The manufacturing process of one embodiment of the invention comprises the following steps:
a) forming (1) of glass primary containers,
b) injection (3) of plastic parts, namely complementary devices (4) ,
c) assembly (5) of the empty primary containers with corresponding complementary devices to form assembled devices (6) , d) washing ( 7 ) the assembled devices with water for injection,
e) nesting (8} the assembled devices in a tray (9} ,
f) closing a secondary container containing the tray and the assembled devices,
g) sterilising {10} the assembled devices in the closed secondary container,
h) preparing the closed secondary container for transportation to a remote site.
The following operation will be carried at the costumer site:
i) filling {11) and stoppering the primary containers of the assembled devices,
j) inspecting (12) the assembled devices in a sterile environment,
k) and final packing (13) of the inspected assembled devices.
In contrast, manuf cturing processes of the prior art generally comprise the following steps:
a) manufacturing (14) of the primary containers (2) ,
b) washing (15) the primary containers, c) nesting (16) the primary containers in a tray,
d) sterilising (17) the primary containers in a secondary container,
The following operation will be carried at the costumer site:
e) filling {18} and stoppering the primary containers ,
f) inspecting (19) the primary containers, g) assembling (20) the primary containers with corresponding complementary devices,
h) inspecting (21} the primary containers assembled with corresponding complementary devices,
i) final packing (22) of the inspected primary containers assembled with corresponding complementary devices.
In the present invention, the primary containers may optionally be syringes or glass containers, pre-fillable with drugs for medical use, and may be formed (1) by a glass-forming device. Any plastic parts, such as complementary devices, may be formed by injection moulding (3) . After manufacture, the empty primary containers are assembled (5) with corresponding complementary devices to yield assembled devices (6) . In one embodiment of the present invention, the primary containers comprise pre-fillable glass syringes (2). The corresponding complementary devices (4) are safety devices (24) for preventing injury from the bare needle tips of the syringes after injection as well as, optionally, rigid needle shields (25) for preventing injury before inj ection.
The empty primary containers assembled with the complementary devices must be washed (7), preferably using water for injection. The assembled devices are then transferred into a sterile environment by means of packing them in a secondary container. The secondary container preferably comprises a tray (9) with a plurality of seats into which the assembled devices (6) can be nested such that they are held in a precise position and are held fixedly during transport. This facilitates correct positioning in the x-y plane for accurate filling and stoppering of the devices ( 6} . The tray (9), which is preferably made of a rigid or semi-rigid plastic material and contains the nested assembled devices (6), is then preferably inserted into a tub of the secondary container. This tub is also preferably made of rigid or semirigid plastic and preferably has a transparent section to allow inspection of the contents thereof, in particular the assembled devices. The nest-and-tub design of the secondary packaging is suitable for keeping the assembled devices (6) separate from one another, thereby preventing scratches or other damage.
A peelable sheet of the secondary packaging is applied to the peripheral edge of the tub in order to close the secondary container and seal the assembled devices within the secondary container. The tub is preferably not permeable, whereas the sheet is preferably made of a selectively impervious material that prevents contamination of the assembled devices by micro-organisms, bacteria and/or biologically active materials while remaining permeable to a sterilisation agent such as ethylene oxide gas. The closed secondary container and its contents are subsequently sterilised (10) and prepared for transfer to a remote site where the remaining steps can be carried out.
After transfer to a different site, the primary containers of the assembled devices (6) are filled (11) with the desired substance, such as drugs for medical use, and stoppered in the sterile environment. In the case where the primary containers are syringes (2) , the stoppering comprises , insertion of plungers (23) thereinto. After filling (11) and stoppering, the assembled devices (6) in the sterile environment are visually and/or functionally inspected (12). This can preferably be done either by operators or inspectors and/or by automated systems having one or more cameras and corresponding software. The inspection may check, among other, the colour, amount and other properties of the filled substance, the shape, aesthetics and functional aspects of the primary containers, presence and correct positioning of the stoppers, functionality of moving any parts, and the correct appearance and assembly of the complementary devices (4). The transparent section of the complementary devices (4) allows of the filled primary containers (2) inside the complementary devices (4) .
The process may optionally comprise a further step of final packing (13) of the inspected assembled devices (6) .
The secondary container and/or the final packaging preferably comprise information for identification and traceability of the contents, such as an RFID system.
The manufacturing process for packing of injectables thus conceived is susceptible to numerous modifications and variations, all falling within the scope of the inventive concept; furthermore, all details may be substituted by technically equivalent elements.
In practice, any material type or size may be used, according to the needs and the state of the art.

Claims

Manufacturing process for packing of injectables for medical use, characterised in that it comprises in temporal sequence the steps of:
forming {1) of glass primary containers,
forming by plastic injection (3) of complementary devices (4),
assembling (5) of the empty primary containers with corresponding complementary devices to form assembled devices (6),
washing (7) the assembled devices with water for injection,
nesting (8) the assembled devices in a tray (9) ,
inserting said tray housing said assembled devices into a secondary container and closing said secondary container,
sterilising (10) the assembled devices in the closed secondary container,
preparing the closed secondary container for transportation to a remote site.
Manufacturing process as claimed in claim 1, characterised in that of comprising a further step of filling and stoppering said primary containers of said assembled devices by insertion of plungers thereinto .
Manufacturing process as claimed in any preceding claim, characterised in that said primary containers are pre-fillable syringes.
Manufacturing process as claimed in any preceding claim, characterised in that said complementary devices are safety devices for preventing injury from the bare needle tips of said syringes.
Manufacturing process as claimed in any preceding claim, characterised in that said closing step of said secondary container comprises applying a peelable, permeable sheet to the peripheral edge of a tub of said secondary container so as to seal said tray housing said assembled devices within said secondary container.
Manufacturing process as claimed in any preceding claim, characterised in that of said tray having a plurality of seats for precise fixation and positioning of said assembled devices in an x-y plane for accurate filling and stoppering thereof. Manufacturing process as claimed in any preceding claim, characterised in that of said assembled devices having at least one transparent section for allowing said inspection of said primary filled devices therethrough.
Manufacturing process as claimed in any preceding claim, characterised in that said inspection comprises inspection by an operator.
Manufacturing process as claimed in any preceding claim, characterised in that said inspection comprises automated inspection by at least one camera and corresponding software.
Manufacturing process as claimed in any preceding claim, characterised in that it comprises a further step of final packing.
PCT/EP2010/060332 2010-07-16 2010-07-16 Manufacturing process for packing of injectables WO2012007056A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP10734485.5A EP2593369A1 (en) 2010-07-16 2010-07-16 Manufacturing process for packing of injectables
PCT/EP2010/060332 WO2012007056A1 (en) 2010-07-16 2010-07-16 Manufacturing process for packing of injectables
MX2013000382A MX2013000382A (en) 2010-07-16 2010-07-16 Manufacturing process for packing of injectables.
CA2804814A CA2804814C (en) 2010-07-16 2010-07-16 Manufacturing process for packing of injectables
JP2013518961A JP2013534195A (en) 2010-07-16 2010-07-16 Manufacturing process for packing injections
BR112013001033A BR112013001033A2 (en) 2010-07-16 2010-07-16 manufacturing process by injecting packaging
US13/809,620 US20140223862A1 (en) 2010-07-16 2010-07-16 Manufacturing Process For Packing Of Injectables
CN2010800679578A CN103118945A (en) 2010-07-16 2010-07-16 Manufacturing process for packing of injectables

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2010/060332 WO2012007056A1 (en) 2010-07-16 2010-07-16 Manufacturing process for packing of injectables

Publications (1)

Publication Number Publication Date
WO2012007056A1 true WO2012007056A1 (en) 2012-01-19

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/060332 WO2012007056A1 (en) 2010-07-16 2010-07-16 Manufacturing process for packing of injectables

Country Status (8)

Country Link
US (1) US20140223862A1 (en)
EP (1) EP2593369A1 (en)
JP (1) JP2013534195A (en)
CN (1) CN103118945A (en)
BR (1) BR112013001033A2 (en)
CA (1) CA2804814C (en)
MX (1) MX2013000382A (en)
WO (1) WO2012007056A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2659980A1 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with the same
EP2659981A1 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding a plurality of containers for medical, pharmaceutical or cosmetic applications and transport or packaging container and method for treating such containers
EP2659979A2 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding of a number of containers for medical, pharmaceutical or cosmetic applications and transport or packaging container
EP2659922A2 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with the same
WO2013164422A2 (en) 2012-05-03 2013-11-07 Schott Ag Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications
DE102012025616A1 (en) 2012-05-03 2013-11-07 Schott Ag Halt structure i.e. halt bar, for use in transporting or packaging container to simultaneously hold e.g. vials, has weakening or folding portions formed in transition regions between portions of bar with and without c
DE102012103899A1 (en) 2012-05-03 2013-11-07 Schott Ag Method for handling and processing container for storing e.g. cosmetic substance, involves conveying containers from carrier to process station by conveying device while containers are held in carrier openings in two-dimensional array
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104548279A (en) * 2015-01-12 2015-04-29 江苏磐宇科技有限公司 Production method of needle replaceable self-destructive syringe
US10675123B2 (en) 2016-07-11 2020-06-09 Shl Medical Ag RFID tag enabled needle shield
US11465794B2 (en) * 2017-12-04 2022-10-11 Hoffmann-La Roche Inc. Packaging line for pre-filled syringes and automated packaging process
WO2021001325A1 (en) * 2019-07-01 2021-01-07 Becton Dickinson France System and method for tracking data relating to the processing of medical containers

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6189292B1 (en) 1998-03-13 2001-02-20 Becton Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
EP1447328A2 (en) * 2003-01-21 2004-08-18 Probitas Pharma, S.A. A method for the sterile dosing of vials
US20060054523A1 (en) 2000-11-20 2006-03-16 Jean-Yves Porret Package for sterile products
EP1818069A1 (en) * 2006-02-14 2007-08-15 Gerresheimer Bünde GmbH Process for manufacturing syringes to be pre-filled

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4013A (en) * 1845-04-26 Machine fqe making match-splihts and arranging them in dipping
US3559645A (en) * 1968-07-01 1971-02-02 Kathryn C Schaller Disposable syringe
US3737973A (en) * 1970-10-20 1973-06-12 Becton Dickinson Co Method and device for assembling a stopper to a syringe barrel
US3807119A (en) * 1972-06-21 1974-04-30 W Shields Method of assembling a multiple compartment hypodermic syringe
US4636201A (en) * 1985-11-01 1987-01-13 American Hospital Supply Corporation Hypodermic syringe having a protective sheath cover
US5898830A (en) * 1996-10-17 1999-04-27 Network Engineering Software Firewall providing enhanced network security and user transparency
SE9601540D0 (en) * 1996-04-23 1996-04-23 Pharmacia Ab Improved medical containers
US5749860A (en) * 1996-09-30 1998-05-12 Kyte; Terreena Disposable self-capping needle
DE19652708C2 (en) * 1996-12-18 1999-08-12 Schott Glas Process for producing a filled plastic syringe body for medical purposes
US5989229A (en) * 1997-05-28 1999-11-23 Becton, Dickinson And Company Needle cover assembly having self-contained drug applicator
US5938644A (en) * 1998-09-01 1999-08-17 Chrisom, Inc. Needle protection holder
JP2000167022A (en) * 1998-12-04 2000-06-20 Showa Denko Kk Double-room medical container
US6613022B1 (en) * 2000-05-05 2003-09-02 Safety Syringes, Inc. Passive needle guard for syringes
DE10109166A1 (en) * 2001-02-25 2002-09-12 Combinature Biopharm Ag Avilamycin derivatives
US7144389B2 (en) * 2001-03-14 2006-12-05 Tyco Healthcare Group, Lp Safety shield for medical needles
FR2839892B1 (en) * 2002-05-27 2005-03-18 Mb Innovation INJECTION DEVICE FOR SINGLE USE INTENDED FOR PRE-FILLING
CA2489804C (en) * 2002-06-19 2008-03-25 Medical Instill Technologies, Inc. Sterile filling machine having needle filling station within e-beam chamber
CN101033010A (en) * 2006-03-09 2007-09-12 麦迪森企业股份有限公司 Method of packaging matter in plastic container and flow process of manufacturing the container
JP5374159B2 (en) * 2006-12-20 2013-12-25 三菱瓦斯化学株式会社 Prefilled syringe
US8038654B2 (en) * 2007-02-26 2011-10-18 Becton, Dickinson And Company Syringe having a hinged needle shield

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6189292B1 (en) 1998-03-13 2001-02-20 Becton Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US6263641B1 (en) 1998-03-13 2001-07-24 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US6792743B2 (en) 1998-03-13 2004-09-21 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US20060054523A1 (en) 2000-11-20 2006-03-16 Jean-Yves Porret Package for sterile products
EP1447328A2 (en) * 2003-01-21 2004-08-18 Probitas Pharma, S.A. A method for the sterile dosing of vials
EP1818069A1 (en) * 2006-02-14 2007-08-15 Gerresheimer Bünde GmbH Process for manufacturing syringes to be pre-filled

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2659980A1 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with the same
EP2659981A1 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding a plurality of containers for medical, pharmaceutical or cosmetic applications and transport or packaging container and method for treating such containers
EP2659979A2 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding of a number of containers for medical, pharmaceutical or cosmetic applications and transport or packaging container
EP2659922A2 (en) 2012-05-03 2013-11-06 Schott AG Support structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with the same
DE102012111624A1 (en) 2012-05-03 2013-11-07 Schott Ag Process for treating or processing containers for medical or pharmaceutical applications and carriers and transport or packaging containers therefor
WO2013164422A2 (en) 2012-05-03 2013-11-07 Schott Ag Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications
DE102012025616A1 (en) 2012-05-03 2013-11-07 Schott Ag Halt structure i.e. halt bar, for use in transporting or packaging container to simultaneously hold e.g. vials, has weakening or folding portions formed in transition regions between portions of bar with and without c
DE102012103896A1 (en) 2012-05-03 2013-11-07 Schott Ag Supporting structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with self
DE102012103899A1 (en) 2012-05-03 2013-11-07 Schott Ag Method for handling and processing container for storing e.g. cosmetic substance, involves conveying containers from carrier to process station by conveying device while containers are held in carrier openings in two-dimensional array
DE102012103898A1 (en) 2012-05-03 2013-11-07 Schott Ag Supporting structure for simultaneously holding a plurality of medical or pharmaceutical containers and transport or packaging container with self
DE102012110339A1 (en) 2012-05-03 2013-11-07 Schott Ag Holding structure for simultaneously holding a plurality of medical or pharmaceutical containers as well as transport or packaging containers with self and method for treating such containers
EP2740537A1 (en) 2012-05-03 2014-06-11 Schott AG Support structure for simultaneously holding a plurality of containers for the storage substances for medical, pharmaceutical or cosmetic applications and transport or packaging containers with same
EP2848882A1 (en) 2012-05-03 2015-03-18 Schott AG Method and device for crimping containers for the storage of substances for medical, pharmaceutical or cosmetic uses
DE102012103899B4 (en) * 2012-05-03 2016-09-22 Schott Ag Method and device for treating containers for storing substances for medical or pharmaceutical applications
US9555911B2 (en) 2012-05-03 2017-01-31 Schott Ag Process for handling or processing containers for medical or pharmaceutical applications and carrier and transport or packaging container thereof
DE202013012689U1 (en) 2012-05-03 2018-07-04 Schott Ag Holding structure for simultaneously holding a plurality of containers for storing substances for medical, pharmaceutical or cosmetic applications as well as transport or packaging containers and combination with self
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US10918754B2 (en) 2017-03-27 2021-02-16 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

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EP2593369A1 (en) 2013-05-22
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BR112013001033A2 (en) 2019-09-24
MX2013000382A (en) 2013-09-02

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