EP0679574A1 - Verfahren und Vorrichtung zum Füllen eines geschlossenen Behälters in aseptischen Bedingungen - Google Patents

Verfahren und Vorrichtung zum Füllen eines geschlossenen Behälters in aseptischen Bedingungen Download PDF

Info

Publication number: EP0679574A1
Authority: EP; European Patent Office
Prior art keywords: filling; needle; hollow; container; fluid
Prior art date: 1994-04-26
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.): Granted

Application number

EP95400817A

Other languages

English (en)

French (fr)

Other versions

EP0679574B1 (de

Inventor

Daniel Py

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Individual

Original Assignee

Individual

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.)

1994-04-26

Filing date

1995-04-11

Publication date

1995-11-02

1995-04-11 Application filed by Individual filed Critical Individual

1995-11-02 Publication of EP0679574A1 publication Critical patent/EP0679574A1/de

2000-06-28 Application granted granted Critical

2000-06-28 Publication of EP0679574B1 publication Critical patent/EP0679574B1/de

2015-04-11 Anticipated expiration legal-status Critical

Status Expired - Lifetime legal-status Critical Current

Links

238000000034 method Methods 0.000 title claims abstract description 35
239000012530 fluid Substances 0.000 claims abstract description 43
239000000463 material Substances 0.000 claims abstract description 21
239000007789 gas Substances 0.000 claims description 25
238000007789 sealing Methods 0.000 claims description 9
238000009434 installation Methods 0.000 claims description 7
239000007788 liquid Substances 0.000 claims description 4
239000000203 mixture Substances 0.000 claims description 4
238000004891 communication Methods 0.000 claims description 3
239000003755 preservative agent Substances 0.000 claims description 3
230000001360 synchronised effect Effects 0.000 claims description 3
239000013013 elastic material Substances 0.000 claims description 2
230000002335 preservative effect Effects 0.000 claims description 2
239000003570 air Substances 0.000 description 9
229920001971 elastomer Polymers 0.000 description 7
230000008569 process Effects 0.000 description 7
229920002633 Kraton (polymer) Polymers 0.000 description 5
238000010438 heat treatment Methods 0.000 description 5
239000004033 plastic Substances 0.000 description 5
230000001954 sterilising effect Effects 0.000 description 5
238000004500 asepsis Methods 0.000 description 4
230000005855 radiation Effects 0.000 description 4
239000000806 elastomer Substances 0.000 description 3
230000004927 fusion Effects 0.000 description 3
238000002347 injection Methods 0.000 description 3
239000007924 injection Substances 0.000 description 3
238000002844 melting Methods 0.000 description 3
230000008018 melting Effects 0.000 description 3
239000002245 particle Substances 0.000 description 3
238000004659 sterilization and disinfection Methods 0.000 description 3
RRHGJUQNOFWUDK-UHFFFAOYSA-N Isoprene Chemical compound CC(=C)C=C RRHGJUQNOFWUDK-UHFFFAOYSA-N 0.000 description 2
230000015572 biosynthetic process Effects 0.000 description 2
239000002775 capsule Substances 0.000 description 2
230000015556 catabolic process Effects 0.000 description 2
238000006731 degradation reaction Methods 0.000 description 2
239000003814 drug Substances 0.000 description 2
239000011521 glass Substances 0.000 description 2
239000011261 inert gas Substances 0.000 description 2
230000036512 infertility Effects 0.000 description 2
238000004519 manufacturing process Methods 0.000 description 2
229920001195 polyisoprene Polymers 0.000 description 2
238000002360 preparation method Methods 0.000 description 2
238000010408 sweeping Methods 0.000 description 2
230000008719 thickening Effects 0.000 description 2
241000894006 Bacteria Species 0.000 description 1
IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 1
241001080024 Telles Species 0.000 description 1
241001639412 Verres Species 0.000 description 1
241000700605 Viruses Species 0.000 description 1
230000004913 activation Effects 0.000 description 1
239000012080 ambient air Substances 0.000 description 1
235000013361 beverage Nutrition 0.000 description 1
230000008859 change Effects 0.000 description 1
239000003283 colorimetric indicator Substances 0.000 description 1
230000002860 competitive effect Effects 0.000 description 1
230000007812 deficiency Effects 0.000 description 1
238000005553 drilling Methods 0.000 description 1
239000013536 elastomeric material Substances 0.000 description 1
230000008030 elimination Effects 0.000 description 1
238000003379 elimination reaction Methods 0.000 description 1
238000005429 filling process Methods 0.000 description 1
238000001914 filtration Methods 0.000 description 1
230000004907 flux Effects 0.000 description 1
244000005700 microbiome Species 0.000 description 1
230000036961 partial effect Effects 0.000 description 1
244000052769 pathogen Species 0.000 description 1
229940071643 prefilled syringe Drugs 0.000 description 1
230000010349 pulsation Effects 0.000 description 1
239000000523 sample Substances 0.000 description 1
238000000926 separation method Methods 0.000 description 1
239000000243 solution Substances 0.000 description 1
239000000725 suspension Substances 0.000 description 1
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1

Images

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
- B65B31/04—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
- B65B31/08—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied the nozzle being adapted to pierce the container or wrapper
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages

Definitions

the filling prefferably carried out under conditions such that variations in the ambient temperature or pressure of the room in which the filling is carried out do not influence the dose of medicament delivered into the container, and therefore the or the doses subsequently delivered by the container.
the thickness of the material at the piercing level will be sufficient to ensure that the pocket closes effectively after withdrawal of the needle; this thickness will, in practice, be chosen proportional to the diameter of the needle used and inversely proportional to the degree of elasticity of the material.
this thickness will be of the order of 2 mm.
solidity of the hollow needles taking into account the thickness which they have to pierce.
the container can take all the configurations such as for example bottle, vial, bottle, pocket or pouch.
the evacuation needle will preferably be separate and spaced at least 1 mm, preferably at least 5 mm, and very particularly at least 10 mm, from that of filling.
the hole used for the evacuation is preferably carried out near one end of the container, this end being chosen so as to be the highest point of the container during filling.
the perforating end of the hollow evacuation needle is also maintained under aseptic conditions.
a succession of steps for filling a container may for example be as follows: installation of the container, activation of the pump, introduction of hollow needles into the part or parts of the container suitable for this function, opening of the container. '' suction needle, opening the filling needle, filling, closing the suction needle, removing the needles, and if desired sealing the suction and filling ports.
the above steps illustrate the case of using a pump, which can be used both for suction and to accelerate filling and in the case where two needles are used, one for introducing the fluid and the 'other for the evacuation of the fluid, such as air, preexisting in the container.
a pump which can be used both for suction and to accelerate filling and in the case where two needles are used, one for introducing the fluid and the 'other for the evacuation of the fluid, such as air, preexisting in the container.
the piercing end of the aspiration needle can be provided with a liquid-sensitive probe, so that both the filling and aspiration functions are stopped when the filling level thus detected is reached.
the present invention also relates to a method characterized in that further perfecting the closure at the location or locations perforated (s) by a hollow needle, preferably by heat sealing or use of a laser beam .
FIG. 1 represents in section a container made of elastomeric material such as kraton® provided with a pump serving for the delivery of unit doses of fluid and placed in its plastic support, the assembly being installed in a basket of a filling installation according to the invention.
kraton® elastomeric material
FIG. 1 represents in section a container made of elastomeric material such as kraton® provided with a pump serving for the delivery of unit doses of fluid and placed in its plastic support, the assembly being installed in a basket of a filling installation according to the invention.
FIG. 2 represents, still under the same conditions, the same elements as well as the injection of the fluid and the aspiration of the preexisting fluid in the hermetically closed pocket.
Figure 3 shows, under the same conditions, the container in its support, the assembly being installed in a basket of the filling installation while the filling and evacuation needles have been removed, and have been replaced by a heating device, capable of effecting complete sealing by fusion, at the level of the piercing orifices.
the container 1 can be seen, made entirely of material capable of being pierced by a hollow needle and sufficiently elastic to close by itself after removal of the hollow needle, here made of kraton®, comprising two parts 2A and 2B specifically designed to be pierced and to close more effectively due to their additional thickness.
FIG. 2 one can observe through the envelope 1 two hollow needles 8R for filling and 8E for evacuation.
This filling step is preferably carried out on a vibrating table to cause any bubble which may have formed during filling to rise to the top of the envelope, opposite the evacuation needle.
hollow filling needle 8R is located below the hollow evacuation needle 8E which is introduced near the top of the envelope.
This sealing makes the method and the installation of the present invention particularly advantageous when it is a question in particular of storing the container for an extended period of time.
the arrival of laminar flow may take place in an airtight hood with non-sterile bodies, under which all or part of the various operations mentioned above will take place.
the operating space will only be accessible to the operator using sterile gloves.

Landscapes

Engineering & Computer Science (AREA)
Mechanical Engineering (AREA)
Chemical & Material Sciences (AREA)
Dispersion Chemistry (AREA)
Health & Medical Sciences (AREA)
General Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
Pharmacology & Pharmacy (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Basic Packing Technique (AREA)
Medical Preparation Storing Or Oral Administration Devices (AREA)
Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
Closing Of Containers (AREA)
Supplying Of Containers To The Packaging Station (AREA)
Vacuum Packaging (AREA)

EP95400817A 1994-04-26 1995-04-11 Verfahren und Vorrichtung zum Füllen eines geschlossenen Behälters unter aseptischen Bedingungen Expired - Lifetime EP0679574B1 (de)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
FR9405011		1994-04-26
FR9405011A FR2719018B1 (fr)	1994-04-26	1994-04-26	Procédé pour remplir dans des conditions aseptiques un récipient obturé.

Publications (2)

Publication Number	Publication Date
EP0679574A1 true EP0679574A1 (de)	1995-11-02
EP0679574B1 EP0679574B1 (de)	2000-06-28

Family

ID=9462508

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP95400817A Expired - Lifetime EP0679574B1 (de)	1994-04-26	1995-04-11	Verfahren und Vorrichtung zum Füllen eines geschlossenen Behälters unter aseptischen Bedingungen

Country Status (13)

Country	Link
US (1)	US5641004A (de)
EP (1)	EP0679574B1 (de)
JP (1)	JP3645002B2 (de)
KR (1)	KR100424827B1 (de)
AT (1)	ATE194113T1 (de)
AU (1)	AU1765495A (de)
BR (1)	BR9501779A (de)
CA (1)	CA2147414C (de)
DE (1)	DE69517627T2 (de)
DK (1)	DK0679574T3 (de)
ES (1)	ES2148452T3 (de)
FR (1)	FR2719018B1 (de)
PT (1)	PT679574E (de)

Cited By (1)

* Cited by examiner, † Cited by third party
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Citations (6)

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- 1995-04-11 AT AT95400817T patent/ATE194113T1/de not_active IP Right Cessation
- 1995-04-11 EP EP95400817A patent/EP0679574B1/de not_active Expired - Lifetime
- 1995-04-11 PT PT95400817T patent/PT679574E/pt unknown
- 1995-04-11 DK DK95400817T patent/DK0679574T3/da active
- 1995-04-11 ES ES95400817T patent/ES2148452T3/es not_active Expired - Lifetime
- 1995-04-19 US US08/424,932 patent/US5641004A/en not_active Expired - Lifetime
- 1995-04-20 CA CA002147414A patent/CA2147414C/fr not_active Expired - Lifetime
- 1995-04-25 BR BR9501779A patent/BR9501779A/pt not_active IP Right Cessation
- 1995-04-26 KR KR1019950009922A patent/KR100424827B1/ko not_active Expired - Lifetime
- 1995-04-26 AU AU17654/95A patent/AU1765495A/en not_active Abandoned
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Also Published As

Publication number	Publication date
FR2719018B1 (fr)	1996-07-12
ES2148452T3 (es)	2000-10-16
FR2719018A1 (fr)	1995-10-27
EP0679574B1 (de)	2000-06-28
KR950031009A (ko)	1995-12-18
CA2147414A1 (fr)	1995-10-27
DE69517627T2 (de)	2001-03-01
KR100424827B1 (ko)	2004-05-24
JPH0840494A (ja)	1996-02-13
JP3645002B2 (ja)	2005-05-11
DK0679574T3 (da)	2000-10-23
AU1765495A (en)	1995-11-02
ATE194113T1 (de)	2000-07-15
US5641004A (en)	1997-06-24
PT679574E (pt)	2000-12-29
DE69517627D1 (de)	2000-08-03
CA2147414C (fr)	2007-06-26
BR9501779A (pt)	1995-11-21

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