Sterility testing is the most critical test before the release of a BioPharma product batch.
One of our solutions is the ISOTEST, an isolator which has been specifically designed for this sterility test application, with a continuous work flow thanks to the integrated hatch with separate bio-decontamination, thus providing fast access and short bio-decontamination cycles.
Getinge's ISOTEST provides control of the entire Sterility Testing process. The Siemens PLC control permits easy navigation and minimizes operator errors. This system provides full traceability with monitoring and recording of process parameters.
With optimized air flow management for both positive pressure control and aeration, the Getinge ISOTEST offers energy efficiencies. Leak tightness and safety of the operators are guaranteed thanks to the automatic leak testing procedure for the decontamination airlock and for the whole work area. Additionaly it has ergonomic design to help increase productivity.
Unbroken integrity / sterility when transferring goods in and out of the isolator
Operator protection against both samples and filters
Integrated H2O2 sterlizer
Single user interface for isolator and sterilizer
Isolator Manipulation Devices
Fitted to Getinge isolators
Glove Leak Testers (GLT)
Fast and simple to perform
Flexible-wall and rigid-wall options
Isocyt Freja Isolators
Provides seperation of process from the environment and operator
API Processing Isolators
High-quality 316L stainless steel construction
Aseptic Filling Line Isolators
The core of the DPTE® transfer system is the Alpha port with its secure interlock enabling totally safe connections and disconnections. The DPTE® system enables material to be moved from one sterile zone to another through a non-sterile zone, with leaktight, risk-free reconnection.
The DPTE® system is based on the interaction of an Alpha part with a Beta part – each fitted with a door, a lock and a sealing function.