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WO2010105629A2 - Système et dispositifs pour manipulation aseptique de matériaux - Google Patents

Système et dispositifs pour manipulation aseptique de matériaux Download PDF

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Publication number
WO2010105629A2
WO2010105629A2 PCT/DK2010/050064 DK2010050064W WO2010105629A2 WO 2010105629 A2 WO2010105629 A2 WO 2010105629A2 DK 2010050064 W DK2010050064 W DK 2010050064W WO 2010105629 A2 WO2010105629 A2 WO 2010105629A2
Authority
WO
WIPO (PCT)
Prior art keywords
airlock
chamber
isolator
materials
door
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.)
Ceased
Application number
PCT/DK2010/050064
Other languages
English (en)
Other versions
WO2010105629A3 (fr
Inventor
Søren Klavstrup MATHIASEN
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.)
SM AUTOMATIK AS
Original Assignee
SM AUTOMATIK AS
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 SM AUTOMATIK AS filed Critical SM AUTOMATIK AS
Priority to CA2754536A priority Critical patent/CA2754536A1/fr
Priority to EP10710996A priority patent/EP2408417A2/fr
Priority to AU2010225289A priority patent/AU2010225289A1/en
Publication of WO2010105629A2 publication Critical patent/WO2010105629A2/fr
Publication of WO2010105629A3 publication Critical patent/WO2010105629A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • 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

  • This invention relates to apparatus and devices for aseptic handling and manipulation of devices used in the pharmaceutical industry and in hospitals when handling sterile substances and devices.
  • WO 2008/009288 relates to a sterilisable connector device for establishing fluid connection between a container holding a sterile diluent liquid such as isotonic sodium chloride solution, and a vial holding a pharmaceutical compound, so that the diluent liquid and the pharmaceutical compound are mixed to provide a sterile injection fluid.
  • a sterile diluent liquid such as isotonic sodium chloride solution
  • isolator technology is prescribed to minimise human interventions in processing areas resulting in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment.
  • Access for equipment and materials to the isolator takes place through an airlock chamber.
  • Laminar air flow is prescribed, and the content of particles in the air must be kept below specified limits.
  • Isolators for aseptic handling and manipulation of materials are typically specified to Grade A, i.e. having a laminar air flow at a velocity of 0.36 - 0.54 m/s as a guidance value and no more than 3,500 particles of size 0.5 ⁇ m per m 3 (100 particles per cu. ft.).
  • the air outside the isolator has no more than 35,000 such particles per m 3 , i.e. no more than 10 times as many particles as the upper limit for the isolator chamber.
  • the connector device of WO 2008/009288 has an engagement member with a collar having a rim for receiving the neck of a vial by a lateral movement.
  • the engagement member In order to prevent the vial from being removed and to prevent contamination of portions to be kept sterile, the engagement member must be rotated 180 degrees whereby a member with an external thread is advanced from the engagement member and brought in contact with the rubber seal, whereby lateral movement is prevented and the vial is locked in its position in the collar of the connector device.
  • Connecting the connector device of WO 2008/009288 with a vial and a diluent- liquid container can be done manually or automatically using specialised equipment such as robot technology. Many elemental processes must be performed including the above mentioned rotation of the engagement member of the connector device.
  • the vial and the diluent-liquid container each has a neck with a rubber seal to be pierced when their contents are to be mixed.
  • their rubber seals must be sterilised.
  • the invention provides a system and devices that solve the above problems.
  • the isolator and airlock system of the invention can be placed in a Grade C room where the air may contain 350,000 0.5 ⁇ m particles (10,000 particles per cu. ft.), i.e. 100 times more than the upper limit for the isolator chamber.
  • the Grade C room where the system is placed persons may be present for operating the system.
  • Figure 1 shows a vial connected to a connector device
  • Figure 2 shows the vial and the connector device in figure 1 in a configuration where the vial is locked to the connector device;
  • Figure 3 shows a system for manipulating the vial and the connector device in figure 1;
  • Figure 4 shows schematically a system according to the invention for aseptic handling of materials
  • Figure 5 shows a vial
  • Figure 6 shows schematically the sterilisation of the seal of the vial in figure 5 before being connected to a connector device.
  • Figures 1 and 2 show the connector device 1 disclosed in WO 2008/009288.
  • the connector device 1 has an engagement member 14 with a collar 17 and a rim 18 on the collar.
  • a vial 23 has a neck 34 that by a lateral movement has been received in the collar 17 and retained by the rim 18.
  • the connector device 1 has a tube member 4 with an external thread, and the engagement member 14 has a bore with an internal thread in engagement with the external thread of the tube member 4.
  • the tube member 4 there is a piercing member for piercing the seal 36 of the vial.
  • a piercable cap 40 covers the piercing end of the piercing member.
  • the engagement member 14 is rotated 180 degrees whereby the tube member 4 and the piercable cap 40 are advanced so that the piercable cap 40 protrudes through the central opening 27 in the metal cap 37 covering the seal 36 and is pressed slightly against the top part 41 of the seal. Reversal of this rotation is prevented by detent means on the threaded parts, and removal of the vial is hereby prevented.
  • This structure and function is disclosed in detail in WO 2008/009288.
  • FIG. 3 shows how the rotation of the engagement member 14 is carried out in a device according to the invention.
  • An elongate member 301 is rotatable about an axis of rotation 302.
  • the elongate member 301 has two identical ends each of which has a pair of tongues 303 with a pair of opposed walls that define a radially extending and open-ended space between the tongues.
  • the engagement member 14 of a connector device 1 can be received in the space between the tongues in a radial movement relative to the axis of rotation 302.
  • the connector device 1 and the attached vial 23 are engaged and gripped e.g. by a robot gripping mechanism which places the engagement member 14 as shown in the space between the pair of tongues 303.
  • the vial 23 and the remaining parts of the connector device are held and being prevented from rotation while the entire assembly of the connector device 1 and the vial 23 is moved as indicated by a dashed-line arrow whereby the elongate member 301 is driven in a rotational movement.
  • the engagement member 14 is hereby driven in rotation together with the elongate member 301 and rotated through 180 degrees relative to the vial 23 and the remaining parts of the connector device 1 which are held and being prevented from rotation.
  • a small “x" on the cap 37 of the vial indicates that the vial is not rotated, and a small “o” on the engagement member 14 indicates that it is rotated together with the rotatable elongate member 301.
  • the rotation is 180 degrees and by rotation of the elongate member 301 through this angle the other end is positioned to receive the engagement member of another connecting device. Rotation through other angles than 180 degrees can also be effected if so desired. If the rotation is a fraction 1/n of 360 degrees where n is an integer number, the rotatable member can advantageously have n spaces for engaging and rotating the engagement member 14 equidistantly distributed along a circle with its centre on the axis of rotation. Thereby the rotatable member will always be left in a position ready to receive an engagement member when an engagement member leaves the space after having been rotated.
  • the device preferably has a self-aligning mechanism which aligns an empty space for receiving an engagement member to be rotated.
  • Figures 5 and 6 show a known vial 23 with a seal 36.
  • a metal cap 37 with a central opening 38 covers the seal 36.
  • the metal cap 37 is bent around the neck 35 of the vial 23.
  • the top part 41 of the seal is exposed and must be sterilised before being brought into connection with a connector device 1.
  • Figure 6 illustrates how a spraying device 60 sprays a sterilising fluid such as ethanol onto the top part 41 of the seal of a vial 23.
  • a spraying device 60 sprays a sterilising fluid such as ethanol onto the top part 41 of the seal of a vial 23.
  • the spraying device 60 does not come into contact with any part of the vial but the sterilising liquid is sprayed onto the top part of the vial whereby contamination and cross contamination is prevented.
  • the vial 23 is oriented upside down and the spraying device 60 is arranged below the vial, but any suitable orientation can be used.
  • a non-contacting sensor 61 such as a camera or other suitable device detects the sterilising fluid being sprayed onto the vial and in case of lacking or insufficient spraying the controller (see figure 4) takes appropriate action.
  • the sterilising fluid such as ethanol should be allowed to evaporate and leave the cleaned surface dry before any further action is taken.
  • the sensor or camera 61 is used for detecting that the sterilising fluid has evaporated and the cleaned surface is dry, which indicates that the surface has been sterilised. Only when it has been detected that the sterilising fluid has evaporated, the vial will be connected to a device such as the on disclosed in WO 2008/009288.
  • spraying devices that can be used is model EFD-781 from Engineered Fluid Dispensing.
  • figure 4 is shown schematically the arrangement of a system 400 according to the invention for aseptic handling of materials, and in particular for aseptically connecting a connecting device 1 as disclosed in WO 2008/009288 to a vial and a diluent-liquid container.
  • the system 400 has a Grade A isolator chamber with arrangements for aseptic handling of the materials.
  • the handling is preferably done by programmable robots.
  • Two Grade B airlock chambers, an inlet chamber and an outlet chamber, each having two sliding airlock chamber doors allow materials to be transported into and out of the isolator chamber.
  • Such materials include primarily connector devices, vials 23 and diluent-liquid containers to be connected, but may also include trays and packaging materials.
  • the system includes High Efficiency Particulate Arresting, HEPA, filters Pl and p2 and motor-driven blowers for establishing a laminar air flow in the airlock chambers and in the isolator chamber.
  • a pressure which is higher than the pressure outside the airlock chambers is established, e.g. 15 Pa
  • a pressure which is higher than the pressure in the airlock chambers is established, e.g. 30 Pa.
  • HEPA filters P3 and P4 filter the return air from the airlock chambers and the isolator chamber to ensure that e.g. drugs from vials that are broken inside the isolator chamber or in either of the airlock chambers are filtered and not re- circulated.
  • Transport of materials into the isolator chamber preferably takes place through the entry airlock chamber that is supplied with a laminar air flow through the HEPA filter P2.
  • the return air from the entry airlock chamber is filtered in the HEPA filter P3. This ensures that particles in the outside air that might enter the entry airlock chamber when the airlock door to the outside is open are caught in the HEPA filter P3 and are prevented from entering into the isolator chamber.
  • Transport of materials out from the isolator chamber preferably takes place through the other airlock chamber, the exit airlock chamber, which shares the HEPA filters Pl and P4 with the isolator chamber.
  • Supplemental air for compensating the loss of air through the doors etc. is fed through HEPA filters P5 and P6 where in particular drugs from vials that are broken outside the airlock chambers or the isolator chamber are filtered and are not fed into the airlock chambers or the isolator chamber.
  • a controller is situated in the lower compartment of the system.
  • the controller controls the operation of all components of the system. Since this compartment is not a "clean" area the pressure is kept below the pressure outside the system, e.g. -15 Pa.
  • Particle filter P9 filters the air that enters the lower compartment of the system.
  • the controller controls the robots handling and manipulation of the materials (connector devices, vials and diluent-liquid containers), the operation of the sliding doors and blower motors.
  • the controller In order to maintain aseptic conditions in the isolator chamber and the airlock chambers the controller is adapted to open an airlock door to the outside only when the corresponding airlock door to the isolator chamber is closed. This allows transport of the materials between the outside and the airlock chamber. Further, the controller will open an airlock door to the isolator chamber only when the corresponding airlock door to the outside is closed and aseptic conditions have been established in the airlock chamber. This allows transport of the materials between the airlock chamber and the isolator chamber.
  • the system may have means for monitoring when aseptic conditions actually have been established in individual ones of the airlock chambers and the isolator chamber and open a door to the isolator chamber only when it has been determined based on actual observations that aseptic conditions have been established, or the system may be suitably programmed only to open a door to the isolator chamber after a predefined delay time after the corresponding airlock chamber door to the outside was closed.
  • the airlock doors are sliding doors that require less space than traditional hinged doors.

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)
  • Nutrition Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Manipulator (AREA)

Abstract

L'invention concerne un système pour manipuler des matériaux de manière aseptique, comprenant une chambre isolante aseptique dotée d'agencements pour manipuler des matériaux ; une chambre à sas pourvue d'une paire de portes à sas vers l'extérieur et vers la chambre à sas, respectivement. Un système de filtre HEPA établit un écoulement d'air laminaire dans la chambre à sas et une pression plus élevée dans la chambre à sas qu'à l'extérieur de cette dernière. Un autre système de filtre HEPA établit un écoulement d'air laminaire dans la chambre isolante et une pression plus élevée dans la chambre isolante que dans la chambre à sas. Un contrôleur est conçu pour ouvrir la première porte à sas vers l'extérieur uniquement lorsque la seconde porte à sas vers la chambre isolante est fermée, afin de permettre le transport des matériaux entre l'extérieur et la chambre à sas, et ouvrir la seconde porte à sas vers la chambre d'isolation uniquement lorsque la première porte à sas est fermée et que des conditions aseptiques ont été établies dans la chambre à sas pour permettre le transport des matériaux entre la chambre à sas et la chambre isolante.
PCT/DK2010/050064 2009-03-20 2010-03-19 Système et dispositifs pour manipulation aseptique de matériaux Ceased WO2010105629A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA2754536A CA2754536A1 (fr) 2009-03-20 2010-03-19 Systeme et dispositifs pour manipulation aseptique de materiaux
EP10710996A EP2408417A2 (fr) 2009-03-20 2010-03-19 Système et dispositifs pour manipulation aseptique de matériaux
AU2010225289A AU2010225289A1 (en) 2009-03-20 2010-03-19 System and devices for aseptic handling of materials

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09155764.5 2009-03-20
EP09155764A EP2229928A1 (fr) 2009-03-20 2009-03-20 Système et dispositifs pour la manipulation aseptique de matériaux

Publications (2)

Publication Number Publication Date
WO2010105629A2 true WO2010105629A2 (fr) 2010-09-23
WO2010105629A3 WO2010105629A3 (fr) 2010-11-11

Family

ID=40942381

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2010/050064 Ceased WO2010105629A2 (fr) 2009-03-20 2010-03-19 Système et dispositifs pour manipulation aseptique de matériaux

Country Status (4)

Country Link
EP (2) EP2229928A1 (fr)
AU (1) AU2010225289A1 (fr)
CA (1) CA2754536A1 (fr)
WO (1) WO2010105629A2 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008009288A1 (fr) 2006-07-21 2008-01-24 Polimoon Medical Packaging A/S Dispositif de raccordement et procédé permettant un mélange stérile

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1286222B1 (it) * 1996-09-18 1998-07-08 Awax Progettazione Procedimento ed apparato per il confezionamento di prodotti in atmosfera modificata e controllata, con film saldabile ed impermeabile
DE102004026883B4 (de) * 2004-05-27 2014-12-24 Inova Pharma Systems Gmbh Anordnung zum sterilen Abfüllen
US7146781B1 (en) * 2004-12-06 2006-12-12 Nathan Albert Cole Apparatus and method for insertion of material into uncontaminated containers
US7783383B2 (en) * 2004-12-22 2010-08-24 Intelligent Hospital Systems Ltd. Automated pharmacy admixture system (APAS)
ITBO20060183A1 (it) * 2006-03-15 2007-09-16 Pietro Dovesi Metodo per il confezionamento di flaconi in ambiente sterile ed apparato che attua tale metodo
US7900658B2 (en) * 2006-10-20 2011-03-08 Fht, Inc. Automated drug preparation apparatus including drug vial handling, venting, cannula positioning functionality

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008009288A1 (fr) 2006-07-21 2008-01-24 Polimoon Medical Packaging A/S Dispositif de raccordement et procédé permettant un mélange stérile

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"Manufacture of Sterile Medicinal Products, an EC Guide to manufacturing Practice", 5300320, EUROPEAN COMMISSION

Also Published As

Publication number Publication date
AU2010225289A2 (en) 2011-10-13
WO2010105629A3 (fr) 2010-11-11
CA2754536A1 (fr) 2010-09-23
EP2229928A1 (fr) 2010-09-22
EP2408417A2 (fr) 2012-01-25
AU2010225289A1 (en) 2011-09-22

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