BERNER International GmbH

BERNER Cytostatic Isolator

  • TÜV ISO 9001-mark
  • Made in Germany

BERNER Cytostatic Isolator

The new BERNER cytostatic glove box isolator I-[MaxPro]³ offers you the ideal solution. The distinct separation of process and environment means GMP-compliant manufacturing of CMR pharmaceutical drugs is even made possible in a Class D Cleanroom.

The new cytostatic glove box isolator is based on the already tried and proven TUV*-tested BERNER FlowSafe® safety cabinet for cytostatics. The known 3-filter system is tested and certificated in accordance to DIN 12980, and offers the user personal, product and cross-contamination protection at the highest level.
*accredited German testing authority

Equipped with an innovative glove change system complete with tested and certificated cytostatic protective glovesInnovatives Handschuhwechsel-System für Isolatoren and protective sleeves, the I-[MaxPro]³ offers optimum protection, even in weak spots found in previous glove box designs.

Additional equipment such as monitor work station, particle counter, extra interfaces, special weighing scale work tops, etc. leave no wish unfulfilled. On-site modification of an already existing BERNER C-[MaxPro]³-130 safety cabinet is also possible. 

The device is registered for testing by the TUV, Germany.

Your advantages at a glance:

  • Safety: The BERNER isolator glove box is based on the TUV-tested and certifícated BERNER FlowSafe® safety cabinet for cytostatics with a certified 3-fold HEPA H14 filter system. The TUV appointment for the isolator has already been made.
  • Air quality: The air quality in the inner area corresponds to the operation conditions of cleanroom grade A in accordance with the EU GMP guidelines. Due to the separation of workspace and environment the GMP-compliant manufacturing of cytostatic applications is also possible in grade D cleanrooms.
  • Product protection: An actively ventilated material airlock with HEPA filters ensure the fast and efficient removal of contaminated air.
  • Personal protection: With the innovative glove change system including tested and certificated cytostatic protective gloves and sleeves it is easy to keep to the changing patterns for PPE recommended by Quapos (Quality Standard for the Oncology Pharmacy Service).
  • Ergonomics: The cytostatic glove box isolator has, despite its 3-filter system, maximum leg room and in combination with the height adjustable elevation stand BERNER ErgoMove, can be easily adapted to individual body height with a push of a button.
  • Cleaning: The device is has very few joins and therefore very easy to clean and disinfect.
  • Service friendly: The low-contamination filter change of BERNER safety cabinets also applies to the I-[MaxPro]³.
  • Retrofittable: Subsequent modification of an existing BERNER C-[MaxPro]³-130 safety cabinet
  • on-site is possible.
  • TÜV ISO 9001-mark

    Certified and controlled quality management system according to DIN EN ISO 9001:2000. Testing, certification and control by the named body.
    TÜV Management Service GmbH
    Unternehmensgruppe
    TÜV Süddeutschland
    Ridlerstraße 65
    D-80339 München
    Germany

  • Made in Germany

    Safety equipment developed by German engineers in the BERNER research and test laboratory, manufactured in Germany.
    © Copyright BERNER INTERNATIONAL GMBH