Sterility testing isolator

A modular cGMP Class A / ISO 5 isolation system designed to provide the safest working conditions for sterility testing and quality control in accordance with the Pharmacopoeia. It consists of two chambers: material is placed in the transfer chamber and decontaminated by the integrated VPHP system, then passed to the previously decontaminated 4-glove process chamber without compromising aseptic conditions. The process chamber has engineered laminar flow with HEPA H14 filters and an integrated peristaltic pump. Also available in a compact version (CST-IS).

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Key features

• Guaranteed sterility: HEPA/ULPA filtration, integrated VPHP bio-decontamination and inflatable seals
• Integrated peristaltic pump for membrane-filtration sterility testing
• Integrated VPHP generator: bio-decontamination cycles of 20–50 min
• Automatic leak test of each chamber per ISO 10648-2 (pressure change method)
• PLC control with 12″ touch-screen HMI and intuitive graphics
• Optional integrated automatic glove leak test (ISO 14644-7, Annex E.5)
• Remote support, updates and maintenance via secure VPN
• Very low energy consumption thanks to low-voltage fans

Standards and compliance

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