Product Description
The Sterility Testing Isolators are a cGMP Class A/ISO 5 custom-designed system specifically designed for performing Sterility Testing. They assure the highest air quality of the isolated environment thanks to an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional downflow, return, and exhaust filters.The system is based on a versatile modular concept: the base isolator configuration is composed of a single 4-gloves working chamber which can be easily expanded with additional chambers/airlocks. All isolators are equipped with the HYPER: Tema Sinergie’s integrated Vapor Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decontamination cycle; and inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti-bacteria inhibitors.
Main Features and Benefits
Fully PLC controlled isolator system
Modular configuration concept of the system
VPHP resistant anemometer
VPHP resistant relative humidity and temperature (rH%+T) sensor
Integrated Sliding Control Cabinet made of AISI 316L stainless steel
View/Access panel latches with integrated safety switches
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