EP0116362A2 - Emballage stérile pour composition thérapeutique - Google Patents

Emballage stérile pour composition thérapeutique Download PDF

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Publication number
EP0116362A2
EP0116362A2 EP19840101187 EP84101187A EP0116362A2 EP 0116362 A2 EP0116362 A2 EP 0116362A2 EP 19840101187 EP19840101187 EP 19840101187 EP 84101187 A EP84101187 A EP 84101187A EP 0116362 A2 EP0116362 A2 EP 0116362A2
Authority
EP
European Patent Office
Prior art keywords
container
filter
composition
sterile
dilute
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.)
Withdrawn
Application number
EP19840101187
Other languages
German (de)
English (en)
Other versions
EP0116362A3 (fr
Inventor
Adrian R. Reti
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.)
EMD Millipore Corp
Original Assignee
Millipore Corp
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 Millipore Corp filed Critical Millipore Corp
Publication of EP0116362A2 publication Critical patent/EP0116362A2/fr
Publication of EP0116362A3 publication Critical patent/EP0116362A3/fr
Withdrawn legal-status Critical Current

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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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
    • A61J1/145—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters using air filters
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
    • A61J1/1456—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters using liquid filters
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed

Definitions

  • This invention relates to an apparatus for storing a sterile therapeutic preparation and for subsequently delivering the therapeutic preparation to a patient.
  • sterile concentrated therapeutic preparations Prior to the present invention, sterile concentrated therapeutic preparations have been stored in a hermetically sealed container, typically a thermoplastic, flexible, transparent container. It is desirable to utilize a system including a sterile package containing a concentrate which is subsequently to be diluted just prior to administration in order to avoid the cost and other disadvantages of storing and shipping large volumes and weights of water.
  • the concentrated therapeutic preparations are admixed with a sterile liquid such as sterile and pyrogen-free water or saline, which accounts for most of the weight and bulk of the final product.
  • Typical concentrated compositions which are packaged and subsequently administered to a patient in this manner include intravenous solutions, peritoneal dialysis solutions, irrigation solutions or the like which contain for example amino acids, sugars such as dextrose or glucose, minerals including electrolytes, vitamins or mixtures thereof.
  • the connecting means between the source of the diluting liquid and the receptacle containing the concentrate has always been associated with a relatively high risk of contamination. This is due primarily to the fact that during connection of the source of pyrogen-free diluting liquid to the container, the contents of the container are exposed to the atmosphere and the connector elements are exposed to the external environment which can lead to non-sterile conditions within the container.
  • no means are provided for alerting the user of the container of a change in sterile conditions within the container after its contents are diluted. concentrates, no means are diluted.
  • a package for a concentrated composition adapted to be diluted and subsequently administered to a patient which package includes a container for the concentrated composition, an inlet means for the package which includes a sterilizing filter integrally formed therewith and an outlet means which permits delivery of the diluted composition to the patient.
  • the concentrate is introduced into or formed within the package and the package and concentrate then are sterilized by any convenient means while the interior of the package and the concentrate are sealed_from the outside atmosphere.
  • sterilized and pyrogen-free dilution liquid is introduced into the package through the sterilizing filter, and the flow path downstream of the filter can then be sealed. Thereafter the diluted composition is removed from the package for administration to the patient through the outlet.
  • the concentrated composition and the interior of the container are sterilized in order to render them free of microorganisms.
  • the concentrated composition is introduced into the container and thereafter the container contents as well as the container interior are sterilized such as with ionizing radiation, ethylene oxide or heat.
  • the container is formed of a flexible transparent plastic composition which is moisture proof and impermeable to microorganisms. Suitable polymeric materials include polyvinyl chloride, polyethylene, polypropylene, polyethylene terphthalate or the like.
  • the contents of the container can be introduced therein by any convenient means such as by forming the container about the concentrated composition or by introducing the concentrated composition through an opening which subsequently serves as the outlet for the diluted composition or by any other convenient means.
  • the concentrated composition can be sealed, under sterile conditions, within a pod having a frangible portion which permits removal of the concentrated composition from the pod into the interior of the container so that it can be admixed with diluting liquid within the container.
  • the container must be provided with an inlet means which includes a sterile filter integrally formed therewith and which is positioned so that any diluting liquid subsequently introduced into the container must pass through the filter before entering the container so that the filter retains pyrogens and microorganisms.
  • This filter is formed intergrately with the container so that the entire structure of this invention is of unitary structure.
  • the container of this invention 10 includes a flexible plastic bag 12, an inlet 14 and an outlet 16.
  • the bag 12 contains the concentrate composition 18 which, together with the interior of the bag 12, is presterilized so that the bag contents are pyrogen-free and free of microorganisms.
  • a gas such as ethylene oxide
  • the gas can be introduced through inlet 14 or through outlet 16 prior to sealing it with seal 20.
  • the seal 20 can be made prior to sterilization.
  • the outlet 16 also includes a seal 20 in order to prevent intrusion of the outside atmosphere into the bag 12 after sterilization.
  • the inlet 14 includes a microporous filter 22, suitably supported within a housing 24 which microporous filter 22 prevents passage of microorganisms or pyrogen therethrough.
  • a suitable filter construction for example, is marketed by Millipore Corporation under the trademark, Millex R.
  • the conduit 26 to the filter housing is designed to permit passage of diluting liquid through the filter 22 and into the bag 12 in order to dilute the concentrated composition 18.
  • a frangible seal 27 may be provided to keep the concentrate 18 from leaking back through filter 22.
  • the bag 12 is provided with an inlet 14 which in turn is connected to a filter holder 24 that includes a supported filter 22 and to which is attached conduit 26.
  • the interior of the bag 12 is presterilized as is the pod 28 which contains the concentrate.
  • the pod 28 can be made of any conveniently frangible material which does not contaminate the concentrate such as polypropylene, polyethylene, or other thermoplastic polymer.
  • the pod can be easily be broken at either neck 30 and/or 32 by manually grasping the knobs 34 or 36 indirectly from the outside of the bag 12.
  • the bag 12 also is provided with an outlet 16 which contains a seal 20.
  • the inlet 26 can be provided with a seal 38 such as a heat seal in order to provide further protection against contamination of the contents of the bag 12 prior to administering the contents to a patient.
  • the seal 38 is adapted to be opened under the force of incoming diluting liquid to the bag 12 without rupturing the walls of inlet 26.
  • Diluent liquid is passed into plastic bag portion through conduit 37, filter 22 and inlet 26 when three-way valve 40 is open to permit communication between conduit 38 and inlet 26 while valve 42 is closed.
  • valve 4 0 is positioned to permit pressurized gas to pass from conduit 46 into conduit 44 when valve 42 is open.
  • a pressure sensor 47 is provided to monitor pressure. Gas pressure in conduit 44 and on filter 22 is controlled so that gas does not penetrate the inlet filter 22 because of surface tension effects when conduit 46 and conduit 44 are in communication. The pressurized gas displaces the liquid in conduit 44 and inlet 14.
  • valve 42 then is shut off while preventing communication between conduit 37 and either conduit 46 or conduit 44.
  • the gas pressure decay then is monitored by means of pressure sensor 47. If the pressure decay rate is small, the filter 22 is intact. If the pressure decay rate is high, the filter 22 has a leak or fluid bypass exists.
  • the three-way valve 40 then is closed and conduit 44 is disconnected from the housing for filter 22.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP19840101187 1983-02-11 1984-02-06 Emballage stérile pour composition thérapeutique Withdrawn EP0116362A3 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US46572083A 1983-02-11 1983-02-11
US465720 1983-02-11

Publications (2)

Publication Number Publication Date
EP0116362A2 true EP0116362A2 (fr) 1984-08-22
EP0116362A3 EP0116362A3 (fr) 1985-05-15

Family

ID=23848908

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19840101187 Withdrawn EP0116362A3 (fr) 1983-02-11 1984-02-06 Emballage stérile pour composition thérapeutique

Country Status (1)

Country Link
EP (1) EP0116362A3 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991001135A1 (fr) * 1989-07-17 1991-02-07 Kabivitrum Ab Composition nutritive et procede de preparation de celle-ci
EP0545000A1 (fr) * 1991-12-05 1993-06-09 Victor Grifols Lucas Poche améliorée pour perfusion de liquides
EP0696448A2 (fr) * 1994-08-09 1996-02-14 Material Engineering Technology Laboratory, Inc. Récipient pour liquides pour distribuer des solutions médicales
EP1352663A2 (fr) * 2002-04-12 2003-10-15 Hyclone Laboratories, Inc. Appareils servant à la fabrication de raccords steriles pour fluides et leurs méthodes d'utilisation
EP1437115A1 (fr) * 2001-09-14 2004-07-14 Nipro Corporation Orifice d'alimentation en produit chimique et recipient pour produit chimique pourvu de cet orifice
EP2765971A4 (fr) * 2011-10-11 2015-06-17 Soinial Ab Poche et procédé pour l'administration intraveineuse ou intracorporelle de solution médicale à un patient
US9289522B2 (en) 2012-02-28 2016-03-22 Life Technologies Corporation Systems and containers for sterilizing a fluid
WO2019018200A1 (fr) * 2017-07-17 2019-01-24 Baxter International Inc. Produit médical comprenant un sac de produit pré-rempli
US10617603B2 (en) 2016-01-22 2020-04-14 Baxter International Inc. Sterile solutions product bag
US11021275B2 (en) 2016-01-22 2021-06-01 Baxter International Inc. Method and machine for producing sterile solution product bags

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2817337A (en) * 1953-11-12 1957-12-24 Pablo T Herzig Filtering device for the innocuous preparation of injectable solutions
US3255923A (en) * 1964-02-03 1966-06-14 Lacto Seal Inc Disposable liquid storage and dispensing device
GB2052948A (en) * 1979-06-22 1981-02-04 Biotest Serum Institut Gmbh Apparatus for conserving blood or plasma
FR2465657A1 (fr) * 1979-09-19 1981-03-27 Gerda Sa Laboratoires Emballages de produits alimentaires, comportant un moyen d'introduction d'eau et un moyen d'evacuation du produit dissous dans l'eau
WO1981001248A1 (fr) * 1979-11-01 1981-05-14 Baxter Travenol Lab Procede et dispositif de transfert et de sterilisation d'une solution

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2817337A (en) * 1953-11-12 1957-12-24 Pablo T Herzig Filtering device for the innocuous preparation of injectable solutions
US3255923A (en) * 1964-02-03 1966-06-14 Lacto Seal Inc Disposable liquid storage and dispensing device
GB2052948A (en) * 1979-06-22 1981-02-04 Biotest Serum Institut Gmbh Apparatus for conserving blood or plasma
FR2465657A1 (fr) * 1979-09-19 1981-03-27 Gerda Sa Laboratoires Emballages de produits alimentaires, comportant un moyen d'introduction d'eau et un moyen d'evacuation du produit dissous dans l'eau
WO1981001248A1 (fr) * 1979-11-01 1981-05-14 Baxter Travenol Lab Procede et dispositif de transfert et de sterilisation d'une solution

Cited By (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991001135A1 (fr) * 1989-07-17 1991-02-07 Kabivitrum Ab Composition nutritive et procede de preparation de celle-ci
EP0545000A1 (fr) * 1991-12-05 1993-06-09 Victor Grifols Lucas Poche améliorée pour perfusion de liquides
EP0696448A2 (fr) * 1994-08-09 1996-02-14 Material Engineering Technology Laboratory, Inc. Récipient pour liquides pour distribuer des solutions médicales
JPH0852196A (ja) * 1994-08-09 1996-02-27 Material Eng Tech Lab Inc 薬剤連結口を有する輸液容器
EP0696448A3 (fr) * 1994-08-09 1996-05-01 Shinsozai Sogo Kenkyusho Kk Récipient pour liquides pour distribuer des solutions médicales
US5662642A (en) * 1994-08-09 1997-09-02 Material Engineering Technology Laboratory, Inc. Instillator with medicator-connecting mouth
US7322969B2 (en) 2001-09-14 2008-01-29 Nipro Corporation Liquid-medicine injection port device, and liquid-medicine container provided with the same
EP1437115A4 (fr) * 2001-09-14 2006-11-29 Nipro Corp Orifice d'alimentation en produit chimique et recipient pour produit chimique pourvu de cet orifice
EP1437115A1 (fr) * 2001-09-14 2004-07-14 Nipro Corporation Orifice d'alimentation en produit chimique et recipient pour produit chimique pourvu de cet orifice
EP1352663A3 (fr) * 2002-04-12 2005-10-12 Hyclone Laboratories, Inc. Appareils servant à la fabrication de raccords steriles pour fluides et leurs méthodes d'utilisation
EP1352663A2 (fr) * 2002-04-12 2003-10-15 Hyclone Laboratories, Inc. Appareils servant à la fabrication de raccords steriles pour fluides et leurs méthodes d'utilisation
EP2765971A4 (fr) * 2011-10-11 2015-06-17 Soinial Ab Poche et procédé pour l'administration intraveineuse ou intracorporelle de solution médicale à un patient
US10821197B2 (en) 2012-02-28 2020-11-03 Life Technologies Corporation Containers and systems for processing a fluid
US9289522B2 (en) 2012-02-28 2016-03-22 Life Technologies Corporation Systems and containers for sterilizing a fluid
US9737624B2 (en) 2012-02-28 2017-08-22 Life Technologies Corporation Systems and containers for sterilzing a fluid
US10166306B2 (en) 2012-02-28 2019-01-01 Life Technologies Corporation Containers and systems for processing a fluid
US11833259B2 (en) 2012-02-28 2023-12-05 Life Technologies Corporation Containers and systems for processing a fluid
US11564867B2 (en) 2016-01-22 2023-01-31 Baxter International Inc. Sterile solutions product bag
US11021275B2 (en) 2016-01-22 2021-06-01 Baxter International Inc. Method and machine for producing sterile solution product bags
US10617603B2 (en) 2016-01-22 2020-04-14 Baxter International Inc. Sterile solutions product bag
US11623773B2 (en) 2016-01-22 2023-04-11 Baxter International Inc. Method and machine for producing sterile solution product bags
WO2019018200A1 (fr) * 2017-07-17 2019-01-24 Baxter International Inc. Produit médical comprenant un sac de produit pré-rempli
US11974966B2 (en) 2017-07-17 2024-05-07 Baxter International Inc. Medical product including pre-filled product bag

Also Published As

Publication number Publication date
EP0116362A3 (fr) 1985-05-15

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PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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Effective date: 19860829

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Inventor name: RETI, ADRIAN R.