Pharmalab’s Sterility Testing Isolator is manufactured under technical license from Skan Design, Switzerland.
The soft wall sterility testing unit is designed to allow operators to perform sterility testing in an aseptic ISO class 4 (10) turbulent flow isolator which ensures material integrity. This system provides a cost-effective alternative approach for those customers with limited laboratory space.
Samples to be tested and all associated apparatus and accessories required for testing are loaded into the isolator via an antechamber. When loading is completed, the Isolator is decontaminated with a gas generator (Hydrogen peroxide or Per Acitic Acid), which is supplied as an optional unit. Once the decontamination cycle is complete, the Isolator will automatically switch to a rapid aeration mode to purge the soft wall chamber of gas vapours. When the aeration is complete the isolator starts on the run mode and is ready for the sterility testing procedure. Sterility testing can be done on a membrane filtration system using the optional Millipore steri-test device or any other equivalent system. After the testing is complete, the media samples, etc., will be removed from the antechamber.
  • Aseptic: ISO class 4 (10) turbulent flow isolator, which means that it exceeds the cGMP regulations of ISO Class 5 (100).
  • Sterility Assurance: Surface decontamination can be done with gas generators or manually with cold sterilization. This means the elimination of false positive tests, retests, quarantine, investigations costs and batch rejection.
  • Ergonomics: Soft wall isolator with four large glove ports with equipment integration and height adjustment result in increased test efficiency and greater mobility and productivity of operators.
  • Modular: Can come attached to an antechamber or two or three-glove IsoTransfer isolator and for material transfer which means improved ergonomics and operators’ handling.
  • Cost Effective: No need to build clean room, which means saving over 50% of the capital maintenance and operating costs.

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