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Example: The  cytotoxic isolator I-[MaxPro]³ with coupled safety cabinet

Example: The cytotoxic isolator I-[MaxPro]³ with coupled safety cabinet

Isolator technology "Made by BERNER"

Cytostatic Glove Box Isolator I-[MaxPro]³

The new Berner Glove Box Isolator I-[MaxPro]³ in a unique symbiosis combines the advantages of safety cabinets and glove boxes for the production of CMR-drugs.

The requirements on pharmacies when manufacturing cytostatic applications are extremely A in Bhigh. Especially the area of product protection has moved to the forefront over the past few years. Depending on the size of the pharmacy and the responsible authority, there is an increasing demand for GMP - „A in B“.

However, for smaller pharmacies this requirement is often not technically and/or financially viable.

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

The basis of the new cytostatic glove box is the already tried and proven TUV*-tested BERNER FlowSafe®  cytostatic safety cabinet. 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. Even on-site modification of an already existing  BERNER C-[MaxPro]³-130 safety cabinet is a possiblity. 

An appointment for testing by the TUV, Germany has already been made.

 

Your advantages at a glance:

Product protection: Due to the separation of workspace and environment the GMP-compliant manufacturing of cytostatic applications is even possible in "Class D rooms".

Safety: The 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.

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 simple push of a button. 

Cleaning: The device has very few joins and is therefore very easy to clean and disinfect.

Service friendly: The low-contamination filter change of th eBERNER safety cabinet  also applies to for the new  I-[MaxPro]³.

Retrofittable: The on-site modification of an existing BERNER C-[MaxPro]³-130 safety cabinet is a possible option.

For further information on the cytostatic glove box please see here

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