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GloveFAST Cyto Pharma
Cytostatic isolator for safe handling of toxic substances, TÜV Nord GS-certified
FASTER
Description
The GloveFAST Cyto Pharma is a high-performance negative pressure isolator with vertical laminar airflow, specially developed for the safe preparation and filling of cytotoxic, CMR and other highly potent substances. Thanks to its fully enclosed design with laminar airflow, the isolator ensures strict physical separation between the operator and the process while complying with cleanroom class A in accordance with the EU GMP Guide and DIN EN ISO 14644-1 (ISO 5).
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Features
Features
- Air quality cleanroom class A (unidirectional displacement flow laminar flow) according to EU GMP guide in the entire work area
- Easy cleaning of the interior and exterior surfaces as well as the multifunctional control unit
- Automatic pressure retention test with data storage in the control unit
- Remote control function: external dialling-in to the device via network for possible fault detection (cost savings for service)
- Safe, consistent separation of operator and process thanks to closed system
- Negative pressure operation (-75 Pa) with laminar air flow behaviour and actively controlled fans
- Sterile glove changing system
- Simple monitoring, testing and maintenance
- Ergonomically designed for easy operation, good visibility and high operator comfort
- Selectable display of internal pressure with delayed antivalence time, automatic pressure drop test and pressure drop indicator
- Electropolished, easy-to-clean stainless steel work surface.
- High air exchange rate in the work area and material airlocks for rapid clean-up of contaminated air and rapid removal of disinfectants
- Airlocks with transfer trays, foot switches for doors and interlocking doors
- SIEMENS HMI touch panel (display size 8")
- Software with audit trail and FDA 21 CFR Part 11 compliant
- Stand-by switch/night mode
- Tested and documented quality (IQ/OQ)
- Favourable price-performance ratio compared to custom-made isolators
- Standards-compliant with DIN 12980:2017, EN ISO 14644-7, EN 61010 (electrical installation), VDE / DIN 57789 (testing), VDI 2083-1 and VDI 2083-3 (qualification)
- Air quality cleanroom class A according to EU-GMP Guide and DIN EN ISO 14644-1 class 5
Airflow
- Ambient air (A) is sucked in via H14 HEPA filter, which is located on the transfer chambers, and pressed into the working area of the transfer chambers
- Air is drawn in through the main fan and second HEPA filter (E)
- Compressed air is forced into the plenum, directed via vertical flow HEPA filter and as laminar flow into the working area (B) to protect the product to be treated in the working area
- From here, the air is drawn through perforations in the work surface into the main H14 HEPA filter below the work surface and channelled through the exhaust duct (C) located on the rear wall
- Part of the air is discharged through the H14 exhaust HEPA filter (D)
- This process creates the negative pressure conditions in the work area (B) and thus protects the operator and the environment
Specifications
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