Pharmaceutical Isolator Systems

Isolator applications include sterility test, sterile process, aseptic process, biohazard, toxic and cytotoxic containment.

Pharmaceutical Isolator Systems

  • BioFlex® B10 Compact Pharmaceutical Transfer Isolator Open or Close

    The BioFlex® B10 Flexible Film Transfer/Service Isolator is a multi-functional design which will provide as a minimum EU GMP Grade A clean air working environment for sterile positive pressure or contained negative pressure pharmaceutical applications.    The B10 Isolator can be used for a variety of procedures including transferring product, equipment or materials between isolators or as an extension to a larger isolator for storage.  Operator access to the internal workspace is through gloved sleeves fitted to the front and back canopy panels. 

    Dimensions

    Overall

    1200mm (L)

    750mm (D)

    1900mm (H)

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  • BioFlex® B30 Compact Pharmaceutical Process Isolator Open or Close

    The BioFlex® B30 Flexible Film Pharmaceutical Process Isolator operates at positive or negative pressure, providing an EU Grade A environment for a variety of sterile or contained pharmaceutical processes including sterile or aseptic processing, sterility test, handling and processing cytotoxic drugs or compounds.

    Operator access to the internal workspace is through strategically located gloved sleeves sealed to the front and back canopy panels. 

    Dimensions

    Overall

    1242mm (L)

    990mm (D)

    1954mm (H)

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  • BioFlex® B90 Sterility Test Isolator Open or Close

    BioFlex® B90 Flexible Film Glove Isolator, designed to provide and maintain a secure sterile environment for sterility testing according to pharmacopoeial or client methods, using a Sterility Test pump integrated into the worktray.

    The Isolator design and dimensions will allow a variety of equipment associated with the sterility testing procedures to be housed and operated within the sterile workspace with space remaining available for additional equipment and materials to be added. 

     

    Dimensions

    Overall

    2440mm (L)

    850mm (D)

    1950mm (H)

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  • BioFlex® B100 Biohazard Containment Half Suit Isolator Open or Close

    The BioFlex® B100 Flexible Film Half-Suit Containment Isolator system is designed to operate at negative pressure only, providing a secure contained environment for working with materials infected with pathogens specified as up to SAPO4/ACDP3.

    The isolator can house a variety of equipment required for the processes including an incubator, refrigerator and a centrifuge.  The isolator can also be fitted with cage racking to house groups of rodents in cages.

    The main operator access is provided through a single flexible PVC half-suit with an independent HEPA filtered air supply system.         

     

    Dimensions

    Overall

    2450mm (L)

    2000mm (D)

    2540mm (H)

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  • BioFlex® B100 Pharmaceutical Process Half Suit Isolator Open or Close

    BioFlex® B100 Positive Pressure Flexible Film Half-Suit Isolator designed to provide a minimum EU GMP Grade A environment for Sterile Processing or Sterility Testing applications.  The Half-Suit Isolator has an automatic microprocessor control system, Peracetic Acid vapour or H2O2 gassable transfer port and integral sterility test media pump.

    The main operator access is provided through a single flexible PVC half-suit with an independent HEPA filtered air supply system.

    Dimensions

    Overall

    2450mm (L)

    2000mm (D)

    2534mm (H)

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  • Custom and Bespoke Design Open or Close

    Where our standard models do not fully meet your requirements, we have a wealth of experience in the design and manufacture of bespoke isolators and associated equipment.

    We will meet with you to discuss the process in detail, listen and learn what you are hoping to achieve.  We will then use our experience and skills to develop a solution which can be taken from concept to project realisation using the latest 3D CAD design software in accordance with our ISO9001 Quality Management System.  We will also discuss the preferred method of sterilisation/ decontamination and ensure the isolator materials are compatible and connection systems are suitable for the chosen method.

    The isolator is then validated to ensure all of the relevant regulatory standards and requirements including ISO 14644-1 Cleanroom & Associated Controlled Environment, EU cGMP Guidelines are fully met and an installation, commissioning and validation programme including FAT, SAT DQ, IQ, OQ and PQ is developed and agreed.

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