US3685248A - Process for sterile filling of collyrium flasks and the like and apparatus for carrying out said process - Google Patents

Process for sterile filling of collyrium flasks and the like and apparatus for carrying out said process Download PDF

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Publication number
US3685248A
US3685248A US68686A US3685248DA US3685248A US 3685248 A US3685248 A US 3685248A US 68686 A US68686 A US 68686A US 3685248D A US3685248D A US 3685248DA US 3685248 A US3685248 A US 3685248A
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bag
filter
holder
flask
stopper
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US68686A
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Joezf Guido Godelaine
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    • 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

Definitions

  • a from PROCESS FOR STERILE FILLING OF COLLYRIUM FLASKS AND THE LIKE AND APPARATUS FOR CARRYING OUT SAID PROCESS This invention relates to a process for sterile filling of collyrium flasks and the like as well as to apparatuses for carrying out said process. It is generally recognized and in numerous countries, it is even mandatory to fill up collyrium flasks in sterile conditions.
  • the best method known heretofore to practically meet this requirement comprises sterilizing the flask, its stopper and a filter-holder with a bacteria filter in a sterilization bag suitable therefor, whereupon these elements are removed from the bag or bags to be manipulated with hand under UV-irradiation or not. This direct handling presents a hazard of smearing which cannot be completely excluded even with the said UV-irradiation.
  • the object of this invention is to allow a simple preparation of collyrium under quite sterile conditions.
  • a process which comprises principally disposing the flask, its stopper and a filter-holder with a bacteria filter in a sterilization bag, closing said bag, sterilizing the bag with its content and, after the sterilization, by manipulating the closed bag from outside, namely by locally distorting it, bringing the flask against the outlet opening of the filterholder provided that the latter has not been initially disposed on the flask, filling the flask from outside the bag via a syringe and, by manipulating from outside the bag, removing the filter-holder of the flask and bringing the stopper on the latter and then, opening the bag.
  • the said bag may be closed either by clamping its open end around the filter-holder with bacteria filter so that the inlet opening of the said filter-holder remains outside the bag, or normally in such a way that, before or after the sterilization, a clamping means is adapted outside the bag and around the filter-holder, thereby forming two chambers in the bag, one of said chambers containing the flask, the stopper and the outlet portion of the filter-holder, whereas the second chamber which comprises the inlet portion of the filter-holder, is opened before the injection.
  • the flask leaves the sterile bag or a sterile portion thereof immediately after having beenfilled up and after having been tightened with its drop-stopper. Then, it may be truly question of a quite sterile filling.
  • an apparatus consisting at least of a holder for the flask, a holder for the drop-stopper and a connecting means between said two holders, so that relative turn over and/or translation movements between the flask and the stopper may be induced by manipulation.
  • FIG. 1 is a front view ofan apparatus according to the invention in its two characteristic positions;
  • FIG. 2 shows another embodiment of an apparatus according to the invention
  • FIG. 3 shows a longitudinal section of a third embodiment according to the invention
  • FIG. 4 is a view taken according to arrow F4 of FIG. 2 and FIG. 5 shows the apparatus according to FIGS. 3 and 4, immediately before the preparation of a collyrium.
  • the apparatus according to FIG. 1 comprises principally a holder 1 for the flask 2, a holder 3 for the drop-stopper 4 and, between said two holders, a connecting means 5.
  • the latter is formed, on one hand, by two upright diametral strips 6-7 fixed to the holder 1 and, on the other hand, by two profiled arms 8-9 fixed to holder 3, whereby said strips 6-7 and arms 8-9 are pivotally connected to each other near their ends by means of rivets 10 and 11 respectively.
  • the said both arms 8- 9 have a bent edge portion 12-13 respectively bearing agents the edges of the strips 6 and 7 when the holders 1 and 3 are disposed coaxially.
  • the connecting means 5 consists of an L-shaped plate 14 in which are provided two slots 15 and 16 at right angles to each other. Two sliders 17 and 18 respectively may be shifted along said slots.
  • the flask-holder 1, under the On plate 14 and at one end of slot 15, is fixed a small bracket 19 with a ring 20. Around said ring 20, may be shifted the outlet side of a filter-holder 21 known per se, the latter being disposed coaxially with holder 1.
  • the connecting means 5 is formed by a U-shaped plate 22 with a long leg 23 and a short leg 24, the latter being connected'to each other through a cross-piece 25.
  • a drop-stopper consists of a dropper 4a which may be screwed on the neck of the flask, and of a stopper proper 4b.
  • the dropper 4a is permanently mounted upon flask 2.
  • the stoppper-holder 3 consists of a firstly conical and then cylindrical bore passing through the cross-piece 25 and in which the stopper 4b is pushed.
  • the stopper may be tightened in this pushed position by means of a screw 26.
  • the cross-piece 25 has a bore 27 in which the end of the dropper 4a may be pushed.
  • leg 24 has two diverging guide flanges 28 and 29 bent in the direction of leg 23.
  • the plate 22 is provided with a bore and a bearing piece 30-31 respectively so that an outlet needle 32 of the filter-holder 21 projects also through said bore 27.
  • the flask 2 and the stopper 4 (4b) are firstly fitted in holders 1 and 3 respectively.
  • the filter-holder 21 loaded with a bacteria filter 33 remains either disengaged from the apparatus (FIG. 1) or is mounted on the apparatus (FIGS. 2, 3, 5).
  • the apparatus and the filter are then pushed in a sterilization bag 34 known per se, said bag being then closed.
  • the bag is adapted around the filter-holder 21, e.g. by means of a resilient ring 35, thereby forming two chambers 36-37 respectively in the bag.
  • Chamber 36 comprises the loaded apparatus and the outlet end of the filter-holder 21, whereas chamber 37 comprises only the inlet end of the filter-holder.
  • chamber 37 is opened by cutting or tearing the bag.
  • the flask By manipulating the bag from outside, the flask is brought against the outlet opening of the filter-holder by shifting either the whole apparatus (FIG. 1, right position) or the slider 17 (FIG. 2) towards the filterholder.
  • the above mentioned opening of chamber 37 could just occur at that point.
  • the flask may be filled up with liquid via the filter-holderand the filter by means of a syringe.
  • the flask is then removed from the filter-holder (by shifting the whole apparatus (FIG. 1), by shifting the slider 17 (FIG. 2) or by axially shifting the flask (FIGS.
  • the flask and the stopper are then almost coaxially disposed by pivoting the connecting means 5 (FIG. 1) or by shifting the slider 18 (FIG. 2) or by tilting the flask (FIGS. 3-5). The flask is then shifted towards the stopper and screwed therein.
  • sterilization may of course be carried out with dry heat, steam, radiation and sterilizing gases.
  • the invention is not limited to the above described embodiments.
  • the described apparatuses may be also adapted in accordance with the nature and the shape of the used drop-stoppers.
  • This invention covers also an equipment considered as a new industrial product and consisting of at least a sterilization bag, an apparatus of the above described type and a clamping means intended to divide the said bag into two chambers.
  • a process for sterile filling of collyrium flasks and the like characterized in that it comprises principally disposing the flask, its stopper and a filter-holder with a bacteria filter in a sterilization bag, closing said bag, sterilizing the bag with its content and, after the sterilization, by manipulating the closed bag from outside, namely by locally distorting it, bringing the flask against the outlet opening of the filter-holder provided that the latter has not been initially disposed on the flask, filling the flask from outside the bag via a syringe and, by manipulating from outside the bag, removing the filter-holder of the flask and bringing the stopper on the latter and then opening the bag.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
US68686A 1969-11-10 1970-09-01 Process for sterile filling of collyrium flasks and the like and apparatus for carrying out said process Expired - Lifetime US3685248A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
BE741479 1969-11-10

Publications (1)

Publication Number Publication Date
US3685248A true US3685248A (en) 1972-08-22

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Application Number Title Priority Date Filing Date
US68686A Expired - Lifetime US3685248A (en) 1969-11-10 1970-09-01 Process for sterile filling of collyrium flasks and the like and apparatus for carrying out said process

Country Status (5)

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US (1) US3685248A (en, 2012)
BE (1) BE741479A (en, 2012)
DE (1) DE2048459A1 (en, 2012)
FR (1) FR2071717A5 (en, 2012)
GB (1) GB1278160A (en, 2012)

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US4961448A (en) * 1986-06-13 1990-10-09 R. E. Timm & Associates, Inc. Pressure vessel for dispensing materials and method for filling same
US5641004A (en) * 1994-04-26 1997-06-24 Py; Daniel Process for filling a sealed receptacle under aseptic conditions
US5881536A (en) * 1996-03-20 1999-03-16 Mueller-Wille; Per Method for sterile packing of a substance
US5997811A (en) * 1997-07-02 1999-12-07 Cohesion Technologies, Inc. Method for sterile syringe packaging and handling
US20030088216A1 (en) * 2001-10-03 2003-05-08 Daniel Py Syringe and reconstitution syringe
US6604561B2 (en) 2000-02-11 2003-08-12 Medical Instill Technologies, Inc. Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial
USD485365S1 (en) 2002-09-03 2004-01-13 Medical Instill Technologies, Inc. Vial
US20040141886A1 (en) * 2000-02-11 2004-07-22 Daniel Py Sealed containers and methods of making and filling same
US20040245289A1 (en) * 2000-10-23 2004-12-09 Daniel Py Fluid dispenser having a housing and flexible inner bladder
US20040256026A1 (en) * 2000-02-11 2004-12-23 Daniel Py Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial
US20050178462A1 (en) * 2003-04-28 2005-08-18 Daniel Py Container with valve assembly for filling and dispensing substances, and apparatus and method for filling
WO2006029270A1 (en) * 2004-09-07 2006-03-16 Smith & Nephew, Inc. Methods and devices for sterile field transfer
USD522663S1 (en) 2002-09-03 2006-06-06 Medical Instill Technologies, Inc. Vial
USD527463S1 (en) 2004-01-27 2006-08-29 Medical Instill Technologies, Inc. Vial
US20060191594A1 (en) * 2000-02-11 2006-08-31 Daniel Py Device with needle penetrable and laser resealable portion and related method
US20060196885A1 (en) * 2005-02-21 2006-09-07 Biomet Manufacturing Corp. Method and apparatus for application of a fluid
USD533670S1 (en) 2002-09-03 2006-12-12 Medical Instill Technologies, Inc. Vial
US7290573B2 (en) 2001-10-16 2007-11-06 Medical Instill Technologies, Inc. Dispenser with sealed chamber, one-way valve and needle penetrable and laser resealable stopper
USD561908S1 (en) 2002-09-03 2008-02-12 Medical Instill Technologies, Inc. Vial
US20080316855A1 (en) * 2004-11-23 2008-12-25 Ferrante Joseph M Composite Mixer
US20090250413A1 (en) * 2008-04-04 2009-10-08 Biomet Biologics, Llc Sterile Blood Separating System
US7798185B2 (en) 2005-08-01 2010-09-21 Medical Instill Technologies, Inc. Dispenser and method for storing and dispensing sterile food product
US8182769B2 (en) 2008-04-04 2012-05-22 Biomet Biologics, Llc Clean transportation system
US8757436B2 (en) 2000-10-23 2014-06-24 Medical Instill Technologies, Inc. Method for dispensing ophthalmic fluid
US20140352265A1 (en) * 2003-11-07 2014-12-04 Medical Instill Technologies, Inc. Adjustable filling and sealing method and apparatus therefor
US9296498B2 (en) 2002-06-19 2016-03-29 Medinstill Development Llc Methods of filling a sealed device
US20160199257A1 (en) * 2010-12-29 2016-07-14 Cardinal Health 414, Llc Closed vial fill system for aseptic dispensing
US9456956B1 (en) * 2015-09-29 2016-10-04 Siemens Medical Solutions Usa, Inc. Aseptic assembling of pharmaceutical containers
US20190343500A1 (en) * 2018-05-10 2019-11-14 Boston Scientific Scimed, Inc. Systems and methods for storage of sterile devices
US10906020B2 (en) 2011-07-15 2021-02-02 Cardinal Health 414, Llc Systems, methods and devices for producing, manufacturing and control of radiopharmaceuticals

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2509689A1 (fr) * 1981-07-17 1983-01-21 Ceca Sa Dispositif et procede pour assurer le transfert de facon aseptique d'un liquide contenu dans un recipient jusqu'a un autre recipient
GB9205255D0 (en) * 1992-03-11 1992-04-22 Process Containment Tech Sterilisation unit

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US4961448A (en) * 1986-06-13 1990-10-09 R. E. Timm & Associates, Inc. Pressure vessel for dispensing materials and method for filling same
US5641004A (en) * 1994-04-26 1997-06-24 Py; Daniel Process for filling a sealed receptacle under aseptic conditions
US5881536A (en) * 1996-03-20 1999-03-16 Mueller-Wille; Per Method for sterile packing of a substance
US5997811A (en) * 1997-07-02 1999-12-07 Cohesion Technologies, Inc. Method for sterile syringe packaging and handling
US8347923B2 (en) 2000-02-11 2013-01-08 Medical Instill Technologies, Inc. Device with penetrable and resealable portion and related method
US7980276B2 (en) 2000-02-11 2011-07-19 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion and related method
US9549874B2 (en) 2000-02-11 2017-01-24 Medinstill Development Llc Device with penetrable and resealable portion and related method
US6684916B2 (en) 2000-02-11 2004-02-03 Medical Instill Technologies, Inc. Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial
US20040083686A1 (en) * 2000-02-11 2004-05-06 Daniel Py Method for filling a vial
US20040141886A1 (en) * 2000-02-11 2004-07-22 Daniel Py Sealed containers and methods of making and filling same
US6805170B2 (en) 2000-02-11 2004-10-19 Medical Instill Technologies, Inc. Method for filling a vial
US9051064B2 (en) 2000-02-11 2015-06-09 Medinstill Development Llc Resealable containers and methods of making, filling and resealing same
US20040256026A1 (en) * 2000-02-11 2004-12-23 Daniel Py Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial
US8960242B2 (en) 2000-02-11 2015-02-24 Medinstill Development Llc Sealed containers and methods of filling and resealing same
US9637251B2 (en) 2000-02-11 2017-05-02 Medinstill Development Llc Sealed containers and methods of filling and resealing same
US8631838B2 (en) 2000-02-11 2014-01-21 Medical Instill Technologies, Inc. Device with penetrable and resealable portion and related method
US7445033B2 (en) 2000-02-11 2008-11-04 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion and related method
US7992597B2 (en) 2000-02-11 2011-08-09 Medical Instill Technologies, Inc. Sealed containers and methods of filling and resealing same
US7032631B2 (en) 2000-02-11 2006-04-25 Medical Instill Technologies, Inc. Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial
US6604561B2 (en) 2000-02-11 2003-08-12 Medical Instill Technologies, Inc. Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial
US7967034B2 (en) 2000-02-11 2011-06-28 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion and related method
US7810529B2 (en) 2000-02-11 2010-10-12 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion
US20060191594A1 (en) * 2000-02-11 2006-08-31 Daniel Py Device with needle penetrable and laser resealable portion and related method
US7100646B2 (en) 2000-02-11 2006-09-05 Medical Instill Technologies, Inc. Sealed containers and methods of making and filling same
US20100236193A1 (en) * 2000-02-11 2010-09-23 Daniel Py Sealed Containers and Methods of Filing and Resealing Same
US20100236659A1 (en) * 2000-02-11 2010-09-23 Daniel Py Resealable Containers and Methods of Making, Filling and Resealing Same
US20070000573A1 (en) * 2000-02-11 2007-01-04 Daniel Py Sealed containers and methods of making and filling same
US7726357B2 (en) 2000-02-11 2010-06-01 Medical Instill Technologies, Inc. Resealable containers and assemblies for filling and resealing same
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US20090229702A1 (en) * 2000-02-11 2009-09-17 Daniel Py Device with needle penetrable and laser resealable portion and related method
US7500498B2 (en) 2000-02-11 2009-03-10 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion and related method
US7490639B2 (en) 2000-02-11 2009-02-17 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion and related method
US20080066824A1 (en) * 2000-02-11 2008-03-20 Daniel Py Device with needle penetrable and laser resealable portion and related method
US20080072996A1 (en) * 2000-02-11 2008-03-27 Daniel Py Device with Needle Penetrable and Laser Resealable Portion and Related Method
US8757436B2 (en) 2000-10-23 2014-06-24 Medical Instill Technologies, Inc. Method for dispensing ophthalmic fluid
US8240521B2 (en) 2000-10-23 2012-08-14 Medical Instill Technologies, Inc. Fluid dispenser having a one-way valve, pump, variable-volume storage chamber, and a needle penetrable and laser resealable portion
US20040245289A1 (en) * 2000-10-23 2004-12-09 Daniel Py Fluid dispenser having a housing and flexible inner bladder
US9725228B2 (en) 2000-10-23 2017-08-08 Dr. Py Institute Llc Fluid dispenser having a one-way valve, pump, variable-volume storage chamber, and a needle penetrable and laser resealable portion
US7000806B2 (en) 2000-10-23 2006-02-21 Medical Instill Technologies, Inc. Fluid dispenser having a housing and flexible inner bladder
US9668914B2 (en) 2000-10-23 2017-06-06 Dr. Py Institute Llc Method for dispensing ophthalmic fluid
US20030088216A1 (en) * 2001-10-03 2003-05-08 Daniel Py Syringe and reconstitution syringe
US7779609B2 (en) 2001-10-03 2010-08-24 Medical Instill Technologies, Inc. Method of filling a device
US7186241B2 (en) 2001-10-03 2007-03-06 Medical Instill Technologies, Inc. Syringe with needle penetrable and laser resealable stopper
US7290573B2 (en) 2001-10-16 2007-11-06 Medical Instill Technologies, Inc. Dispenser with sealed chamber, one-way valve and needle penetrable and laser resealable stopper
US8220507B2 (en) 2001-10-16 2012-07-17 Medical Instill Technologies, Inc. Dispenser and method for storing and dispensing sterile product
US9630755B2 (en) 2001-10-16 2017-04-25 Medinstill Development Llc Dispenser and method for storing and dispensing sterile product
US9296498B2 (en) 2002-06-19 2016-03-29 Medinstill Development Llc Methods of filling a sealed device
USD505494S1 (en) 2002-09-03 2005-05-24 Medical Instill Technologies, Inc. Vial
USD485365S1 (en) 2002-09-03 2004-01-13 Medical Instill Technologies, Inc. Vial
USD533670S1 (en) 2002-09-03 2006-12-12 Medical Instill Technologies, Inc. Vial
USD561908S1 (en) 2002-09-03 2008-02-12 Medical Instill Technologies, Inc. Vial
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US20070084524A1 (en) * 2003-04-28 2007-04-19 Daniel Py Container with valve assembly, and apparatus and method for filling
US7077176B2 (en) 2003-04-28 2006-07-18 Medical Instill Technologies, Inc. Container with valve assembly for filling and dispensing substances, and apparatus and method for filling
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US20140352265A1 (en) * 2003-11-07 2014-12-04 Medical Instill Technologies, Inc. Adjustable filling and sealing method and apparatus therefor
US9783326B2 (en) * 2003-11-07 2017-10-10 Medinstill Development Llc Adjustable filling and sealing method and apparatus therefor
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US20060064070A1 (en) * 2004-09-07 2006-03-23 Jeffrey Martin Methods and devices for sterile field transfer
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US20080316855A1 (en) * 2004-11-23 2008-12-25 Ferrante Joseph M Composite Mixer
US8308340B2 (en) 2004-11-23 2012-11-13 Smith & Nephew, Inc. Composite mixer
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US20090250413A1 (en) * 2008-04-04 2009-10-08 Biomet Biologics, Llc Sterile Blood Separating System
US8182769B2 (en) 2008-04-04 2012-05-22 Biomet Biologics, Llc Clean transportation system
US20160199257A1 (en) * 2010-12-29 2016-07-14 Cardinal Health 414, Llc Closed vial fill system for aseptic dispensing
US10226401B2 (en) * 2010-12-29 2019-03-12 Cardinal Health 414, Llc Closed vial fill system for aseptic dispensing
US10906020B2 (en) 2011-07-15 2021-02-02 Cardinal Health 414, Llc Systems, methods and devices for producing, manufacturing and control of radiopharmaceuticals
US9456956B1 (en) * 2015-09-29 2016-10-04 Siemens Medical Solutions Usa, Inc. Aseptic assembling of pharmaceutical containers
US10207046B2 (en) 2015-09-29 2019-02-19 Siemens Medical Solutions Usa, Inc. Aseptic assembling of pharmaceutical containers
US20190343500A1 (en) * 2018-05-10 2019-11-14 Boston Scientific Scimed, Inc. Systems and methods for storage of sterile devices
US11744564B2 (en) * 2018-05-10 2023-09-05 Boston Scientific Scimed, Inc. Systems and methods for storage of sterile devices
US20230355222A1 (en) * 2018-05-10 2023-11-09 Boston Scientific Scimed, Inc. Systems and methods for storage of sterile devices
US12089827B2 (en) * 2018-05-10 2024-09-17 Boston Scientific Scimed, Inc. Systems and methods for storage of sterile devices

Also Published As

Publication number Publication date
DE2048459A1 (de) 1971-05-19
FR2071717A5 (en, 2012) 1971-09-17
GB1278160A (en) 1972-06-14
BE741479A (en, 2012) 1970-04-16

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