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WO1997047377A1 - Systeme jetable de stockage, de transport et de remise en suspension - Google Patents

Systeme jetable de stockage, de transport et de remise en suspension Download PDF

Info

Publication number
WO1997047377A1
WO1997047377A1 PCT/US1997/009821 US9709821W WO9747377A1 WO 1997047377 A1 WO1997047377 A1 WO 1997047377A1 US 9709821 W US9709821 W US 9709821W WO 9747377 A1 WO9747377 A1 WO 9747377A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
mixing
tube
mixing block
dip tube
Prior art date
Application number
PCT/US1997/009821
Other languages
English (en)
Inventor
Mark S. Rienstra
Wendy L. Radcliff
Anand Ekambaram
Doyle W. Stewart
Brett L. Allred
Original Assignee
Merck & Co., Inc.
Hyclone Laboratories, 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
Priority claimed from GBGB9617418.0A external-priority patent/GB9617418D0/en
Application filed by Merck & Co., Inc., Hyclone Laboratories, Inc. filed Critical Merck & Co., Inc.
Priority to AU33036/97A priority Critical patent/AU713099B2/en
Priority to EP97928881A priority patent/EP0907407A4/fr
Priority to JP10501701A priority patent/JP2000513993A/ja
Priority to CA002256621A priority patent/CA2256621C/fr
Publication of WO1997047377A1 publication Critical patent/WO1997047377A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/50—Circulation mixers, e.g. wherein at least part of the mixture is discharged from and reintroduced into a receptacle

Definitions

  • the present invention relates to a system for the transport, storage, mixing and resuspension of sterile and non-sterile liquids.
  • it relates to a system for use with suspensions used in the pharmaceutical industry.
  • the stainless steel systems are not disposable, they must be cleaned and resterilized before being reused. This may involve chemical cleaning with agents such as perchlorate solution, and the attendant disposal problems associated with disposal of such products. After cleaning, the systems must be inspected and tested to assure that all foreign matter has been removed. Since new products will be introduced, validation of the cleaning and resterilization procedures as well as tests to assure efficacy must be completed. This also adds to the costs and complication of using the stainless steel systems.
  • vessel size is usually set to the largest expected batch of material. When small batches are prepared, they are stored in oversized containers with the attendant costs and problems which have been previously described.
  • a sterile alum suspension is prepared in the vessel and shipped to the area where inoculation with the bulk virus or bacteria stock will occur. Since the suspension may be prepared well in advance of inoculation, the system must also serve as a storage container.
  • the alum Prior to inoculation, the alum must often be resuspended. In many instances, uniform particle size and the preparation of a homogeneous suspension of the alum are critical to the success of the final product. Once resuspension has been assured, the suspension may be pumped into a vessel where inoculation will occur or inoculation may be carried out in the storage container.
  • the device In order to provide such a system the device must be capable of assuming any needed volume. It must also be capable of being sterilized and maintaining the sterile environment for extended periods of time. Additionally, the surface of the device which comes in contact with the vaccine suspension must not interact with the product. That is, it must not absorb protein, adjuvants or other ingredients from the suspension. Additionally, all fittings and connections to the device must be sterilizable and must be capable of maintaining the sterility of the product during storage.
  • the new system In order to be practical in an environment including sterile vaccines, the new system must be capable of resuspending alum within a two hour period of time. More conveniently, the resuspension should be possible within 30 minutes.
  • the product must also be capable of being shipped by regular carrier over great distances or moved by conventional carts inside a manufacturing area.
  • the device Since the uniformity of the suspension is critical to the uniformity of the final vaccine product, the device must allow dispensing of product with no apparent settling during the dispensing period. In addition, the system must be designed to deliver as much of the suspension as possible so that only a minimal amount of material is retained within the system once dispensing is complete.
  • the device of this invention provides for a light weight, sterilizable system capable of mixing, storing, resuspending, shipping and dispensing solutions or suspensions.
  • the instant device of this invention has demonstrated the ability to overcome the problems discussed above and provide reliable, homogeneous suspensions for the manufacture, mixing, storage and dispensing of aqueous suspensions.
  • a disposable transport, storage and resuspension system for use in the manufacture of sterile and non-sterile liquids and suspensions comprising a collapsible container and a support device, the collapsible container having means for ingress and egress of fluids and solids into the container and means for mixing and resuspending the contents of the container.
  • Figure 1 is a cross section of the preferred embodiment of the system which includes the collapsible container and the support device.
  • Figure 2 is a schematic diagram of the enclosed mixing system.
  • Figure 3 is a top view of the mixing block.
  • Figure 4 is a side view of the mixing arms.
  • a disposable transport, storage and mixing system for use in the manufacture of sterile and non-sterile liquids and suspensions comprising a collapsible container and a support device, the collapsible container having means for ingress and egress of fluids and solids into the container and means for mixing and resuspending the contents of the container.
  • a "transport, storage and mixing system” is a device which can be used to hold a volume of liquid or liquid and solid in a manner which is suitable for shipping either locally or over great distances, having the capacity to provide for agitation of the contents.
  • the system is configured to provide for the storage, transport and mixing of liquids or liquids and solids which are sterile.
  • the system provides for storage, transport and mixing of a suspension useful in the preparation of a vaccine.
  • the system provides for storage, transport and mixing of an alum suspension that may be inoculated to produce a vaccine.
  • the collapsible container (1) in the drawing includes means for ingress (15) and egress (13) of fluids and solids into and out of the container and means for mixing and resuspending (10, 1 1 and 12) the contents of the container.
  • the collapsible container may be fabricated from any suitable material that will function within the desired temperature range and will not adversely impact the substance to be contained.
  • collapsible container is meant that the container (1 ) will not support its own weight. Therefore, when the container is empty, it collapses upon itself. Since one of the primary functions of the container is for use in the preparation of alum based vaccines, it is further preferred that the collapsible container be designed to withstand sterilization using Gamma irradiation or other suitable techniques which are known in the art.
  • the collapsible container is initially evacuated of air before being treated with Gamma radiation.
  • the collapsible container may then be shipped in its most compact state and stored in this manner until needed.
  • the container expands as needed in response to the added volume of fluid.
  • the head space, or air volume, within the container is held to a minimum.
  • a polymeric material such as linear low density polyethylene is used to produce the collapsible container.
  • This material meets the requirements set forth above in that it will not interact with aqueous solutions or suspensions, does not absorb the media or innoculum used to produce a vaccine and is useful between about 1°C to about 60° C.
  • Other polymeric materials which meet the requirements of this device may also be used to construct the collapsible container.
  • the container comprises three layers, the inner most layers comprising blown film polyethylene and the outer layer is a co-extruded EVOH nylon.
  • the collapsible container (1 ) has means for ingress (15) and egress (13) of fluids and solids into and out of the container. That is, liquids, suspensions and mixtures of liquids and solids may be added to the collapsible container through inlet means such as tube (15).
  • inlet means such as tube (15).
  • valve means such as the hose clamps (14) shown in Figure 1. Since the collapsible container is initially evacuated before use, when clamp ( 14) of tube (15) is opened and fluid flows in, the container expands and take the shape of the support device (2) or if a support device is not present, the collapsible container expands to the limits of its own shape.
  • the support device (2) allows for long distance transport of the container ( 1). Additionally, the angle of the bottom of the support device is crucial for both the suspension of the alum and for complete draining of the container.
  • the collapsible container (1.) is also equipped with means for mixing and resuspending the contents of the container. This is accomplished in the preferred embodiment of the invention using a short dip tube (10) and a full length dip tube (1 1) and a return tube (12), which are connected to a mixing block (60) which is fitted with a plurality of mixing arms.
  • the mixing block may be fabricated from low or high density polyethylene.
  • the tubing connected thereto may be any type of flexible tubing suitable for the operation of the system.
  • Addition of tubing and various fittings is accomplished using thermal welding. This may be accomplished using a Vertrod Heat Sealing Machine or other suitable device.
  • a Vertrod Heat Sealing Machine or other suitable device.
  • the preferred means for mixing and resuspending the contents of the container are shown diagramatically in this view of the preferred device.
  • material from inside the collapsible container may be withdrawn through the short dip tube (10) or the full length dip tube (1 1) depending upon the open or closed state of the snapper clamps ( 14) attached to dip tubes (10) and (1 1 ).
  • the material may be withdrawn using, for example a peristaltic pump (32) and returned to the collapsible container through return tube (12).
  • the short dip tube (10) may protrude from about 1 % to about 80% of the distance from top of the collapsible container to the bottom, when the container is full of liquid. Using this tube, the liquids and solids contained within the collapsible container are drawn from an area above the mixing block (60). Additionally, the full length dip tube (1 1 ) may be used to withdraw material from the container. This tube is connected to the mixing block (60) and communicates the inside of the mixing block (60) with the closed loop system.
  • FIG 3 (a) A top view of the mixing block (60) is shown in Figure 3 (a).
  • This block may be machined from a single piece of suitable plastic, or in the alternative it may be molded either as one piece or as multiple pieces which are then affixed using welding, gluing, mechanical attachment or any other form of attachment known in the art.
  • Port (61 ) is used to connected the full length dip tube (1 1 ) to the mixing block.
  • Port (62) receives the return tube (12).
  • the material which is pumped back through the return tube (12) is diverted in the mixing block and channeled to the spray arms (66) which are shown in Figure 1 , and are attached to the mixing block at ports (64).
  • the contents of the collapsible container may be evacuated through egress tube ( 13) which is connected to the mixing block (60) at port (63).
  • the bottom of the mixing block has openings (65) which communicate the inside of the container with the full length dip tube (1 1 ). Therefore, when the contents of the container (1) are circulated using full length dip tube (1 1), mixing from the bottom of the container is assured.
  • Each spray arm consists of a hollow tube which is open at the end which fits within port (64) of the mixing block and is closed at the opposite end.
  • Each of the spray arms contains a plurality of apertures which communicate the inside of the collapsible container (1 ) with the inside of the mixing block (60).
  • material from within the tank is circulated through the closed loop and pumped back into the mixing block (60) where it is channeled into the spray arms (66) and exits through orifice (70).
  • the position of the various orifices (70) relative to the base of the container is as follows:
  • the mixing arm has a primary set of holes drilled longitudinally along the bottom of the arm (71) which allows fluid to sweep the region of the container under the arm.
  • a secondary set of holes useful in mixing and resuspending material within the container, is drilled along the side of the arm. Beginning at a point closest to the block, the first hole is drilled at an angle of 0°. The subsequent holes along the side of the arm are set at increasing angles up to 45°. The fluid exiting from these secondary holes creates a swirling vortex flow pattern that sweeps the side of the barrel and lifts any sediment towards the upper regions of the bag.
  • the mixing tubes are positioned within the mixing block (60) using locator rods (68) as shown in Figure 4. This allows for accurate and reproducible positioning of the orifices during manufacture.
  • the mixing arms are machined with a set of longitudinal slots (67) in the fitted end.
  • One slot is larger than the others so as to accommodate a locator pin.
  • the main body of the mixing block is machined with holes designed to receive the fitted ends of the arms.
  • the hole design uses a barbed interference fit.
  • the locator pin is inserted into a small pilot hole inside the block.
  • the arms are inserted into the block with the larger slot sliding over the locator pin.
  • the locator pins are situated in the same place on each block to ensure that the arms are properly oriented during manufacture.
  • the most preferred embodiment of this device is a system for use in the manufacture of vaccines which comprises: a collapsible container and a support device, the collapsible container being flexible and having a top, bottom and sides which enclose a volume of space, the bottom of the container having a mixing block being weldably affixed inside the container, the mixing block having a top, bottom and sides, the mixing block further having a plurality of recirculation outlets; the mixing block having a plurality of openings which communicate the inside of the mixing block to the inside of the container; the sides of the mixing block having a plurality of spray arms, the spray arms being directed from the bottom of the container to the sides and top of the container, the spray arms being hollow and attached to the mixing block, the top end of the spray arms being sealed, the spray arms having a plurality of holes which communicate the inside of the container with the inside of the spray arms; the top of the container having an inlet tube which provides for ingress of fluids and solids into the container, the top of the container further
  • the closed loop mixing feature has been shown to be particularly effective in resuspending alum which has settled from a suspension.
  • the pump has a flow capacity of from about 0.5 L/min to about 50 L/min. The most preferred flow velocity is about 20 L/min.
  • 200 L of an alum suspension was introduced into the collapsible container and allowed to stand. At the end of one week, the resuspension of this material was examined using nephlometric measurements of the suspended alum as a function of mixing time. The pump was operated at 20 L/min and samples were taken after first back flushing the system for a period of 15 minutes. As the results in Figure 5 indicate, a homogeneous suspension was achieved after mixing for about 30 minutes. In a similar study, shown in Figure 6, where the suspension was allowed to settle for one month, a homogeneous suspension was again reached in about 30 minutes.
  • the closed loop mixing system also provides a means for maintaining homogeneity during delivery of the suspension. After resuspending material which had settled, the concentration of alum in ⁇ g/ml of the suspension was determined during the emptying of the system. As Figure 7 and 8 indicate, suspensions that stood for one week or one month, both maintained homogeneity during the emptying operation.
  • sampling means such as removable tubes (40) may be included within the loop.
  • the sampling tubes consists of an elastomeric tubing with a sterile plug in the end. This tubing is connected via a sterile welder to another piece of elastomeric tubing connected to the sampling vessel.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Bag Frames (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un récipient de stockage, de mélange, de remise en suspension et de distribution pour solutions ou suspensions stériles ou non stériles. Le dispositif comprend un sac pliable et stérilisable (1) doté d'armatures pour tubes (13, 15) servant à remplir et à vider le sac (1) en fluides et solides. Un bloc mélangeur (60) muni de bras gicleurs (66) est prévu dans le sac (1) pour le mélange et la remise en suspension du contenu de ce sac (1). Le dispositif comporte des tubes plongeurs (10, 11) qui extraient le liquide du sac (1) et le remettent en circulation par un tube de retour (12) relié aux blocs mélangeurs (60). Le liquide, ainsi acheminé vers les bras gicleurs (66), est réinjecté dans le sac (1) par des orifices (64, 69), d'où l'établissement d'un système à boucle fermée pour le mélange. En outre, une structure de support (2) soutient le sac (1) durant les opérations de transport, de remplissage et de distribution. Contrairement au matériel classique en acier inoxidable, le dispositif est jetable, ce qui offre les avantages suivants: absence de nettoyage, remise en suspension fiable, rapide et précise des solides en suspension, et capacité de traitement d'un large éventail de volumes liquides.
PCT/US1997/009821 1996-06-11 1997-06-10 Systeme jetable de stockage, de transport et de remise en suspension WO1997047377A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU33036/97A AU713099B2 (en) 1996-06-11 1997-06-10 Disposable storage, transport and resuspension system
EP97928881A EP0907407A4 (fr) 1996-06-11 1997-06-10 Systeme jetable de stockage, de transport et de remise en suspension
JP10501701A JP2000513993A (ja) 1996-06-11 1997-06-10 使い捨て式の格納、移送、および再縣濁システム
CA002256621A CA2256621C (fr) 1996-06-11 1997-06-10 Systeme jetable de stockage, de transport et de remise en suspension

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US2097096P 1996-06-11 1996-06-11
US60/020,970 1996-06-11
GB9617418.0 1996-08-20
GBGB9617418.0A GB9617418D0 (en) 1996-08-20 1996-08-20 Sterile storage transport and resuspension system

Publications (1)

Publication Number Publication Date
WO1997047377A1 true WO1997047377A1 (fr) 1997-12-18

Family

ID=26309897

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/009821 WO1997047377A1 (fr) 1996-06-11 1997-06-10 Systeme jetable de stockage, de transport et de remise en suspension

Country Status (5)

Country Link
EP (1) EP0907407A4 (fr)
JP (1) JP2000513993A (fr)
AU (1) AU713099B2 (fr)
CA (1) CA2256621C (fr)
WO (1) WO1997047377A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1352685A3 (fr) * 2002-04-12 2005-04-27 Hynetics, LLC Récipient mélangeur
EP1369170A3 (fr) * 2002-04-12 2005-09-21 Hynetics, LLC Système d'agitateur pour mélanger des liquides et son procédé de préparation
GB2446128A (en) * 2007-01-31 2008-08-06 Ge Healthcare Bio Sciences Ab Method and apparatus for forming a homogeneous mixture of chromatography media in a vessel
EP1842800A3 (fr) * 2006-04-05 2009-01-21 Millipore AB Unité jetable
WO2009093995A1 (fr) * 2008-01-25 2009-07-30 Xcellerex, Inc. Système d'élimination de plis de poche, systèmes de détection de fuites, et agitation électromagnétique pour systèmes de confinement de liquides
CN109477054A (zh) * 2016-07-22 2019-03-15 日产化学株式会社 液态培养基组合物的制造方法及用于该制造方法的制造装置

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7950547B2 (en) * 2006-01-12 2011-05-31 Millipore Corporation Reservoir for liquid dispensing system with enhanced mixing
CN102470365B (zh) * 2009-07-24 2014-12-17 Emd密理博公司 供料袋结构
JP6622578B2 (ja) * 2015-12-08 2019-12-18 不二越機械工業株式会社 ワーク加工装置およびこれに用いる薬液収納バッグ

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3647397A (en) * 1969-11-19 1972-03-07 Charles M Coleman Reagent solution preparation
US5160333A (en) * 1991-02-01 1992-11-03 Solco Hospital Products Group, Inc. Method for mixing blood with anticoagulant
US5257983A (en) * 1991-04-12 1993-11-02 Cryopharm Corporation Blood bag for lyophilization
US5385564A (en) * 1992-10-05 1995-01-31 Fresenius Usa, Inc. System for preparation and use of dialysis solution

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3647397A (en) * 1969-11-19 1972-03-07 Charles M Coleman Reagent solution preparation
US5160333A (en) * 1991-02-01 1992-11-03 Solco Hospital Products Group, Inc. Method for mixing blood with anticoagulant
US5257983A (en) * 1991-04-12 1993-11-02 Cryopharm Corporation Blood bag for lyophilization
US5385564A (en) * 1992-10-05 1995-01-31 Fresenius Usa, Inc. System for preparation and use of dialysis solution

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0907407A4 *

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1352685A3 (fr) * 2002-04-12 2005-04-27 Hynetics, LLC Récipient mélangeur
EP1369170A3 (fr) * 2002-04-12 2005-09-21 Hynetics, LLC Système d'agitateur pour mélanger des liquides et son procédé de préparation
EP1842800A3 (fr) * 2006-04-05 2009-01-21 Millipore AB Unité jetable
EP2336051A1 (fr) * 2006-04-05 2011-06-22 Millipore AB Unité jetable
EP2896581A1 (fr) * 2006-04-05 2015-07-22 Merck Chemicals and Life Science AB Unité jetable
GB2446128A (en) * 2007-01-31 2008-08-06 Ge Healthcare Bio Sciences Ab Method and apparatus for forming a homogeneous mixture of chromatography media in a vessel
GB2446128B (en) * 2007-01-31 2009-07-22 Ge Healthcare Bio Sciences Ab Method and apparatus for forming an homogeneous mixture of chromatography media in a vessel
WO2009093995A1 (fr) * 2008-01-25 2009-07-30 Xcellerex, Inc. Système d'élimination de plis de poche, systèmes de détection de fuites, et agitation électromagnétique pour systèmes de confinement de liquides
CN109477054A (zh) * 2016-07-22 2019-03-15 日产化学株式会社 液态培养基组合物的制造方法及用于该制造方法的制造装置
EP3489341A4 (fr) * 2016-07-22 2020-03-25 Nissan Chemical Corporation Procédé de production d'une composition de milieu liquide et dispositif de production utilisé à cet effet

Also Published As

Publication number Publication date
CA2256621C (fr) 2004-12-28
AU713099B2 (en) 1999-11-25
EP0907407A1 (fr) 1999-04-14
JP2000513993A (ja) 2000-10-24
AU3303697A (en) 1998-01-07
CA2256621A1 (fr) 1997-12-18
EP0907407A4 (fr) 1999-09-15

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