Sterility testing isolator

class IIIfor the pharmaceutical industrysampling

The Envair sterility test isolator is designed for sterile processing and sterility testing routines that require an internal sterile environment with EU GMP Grade A air over the workspace with a degree of operator protection. This type of system is widely used by manufacturers of liquid medicinal products and independent sterility test companies. The sterility test isolator is monitored, controlled and alarmed to provide and maintain strict internal environmental conditions within the isolator workspace; this ensures the integrity of the system to achieve the required cleanliness levels. The equipment has been designed and manufactured following cGMP and GAMP 5 guidelines, in addition to industrial equipment directives. Key Features Integrated sterility test pump, flush with chamber base Siemens S7-PLC control system with HMI touchscreen display Automatic inflating silicone seals on main chamber and hatch doors Integrated Vaporised Hydrogen Peroxide (VHP) decontamination system capable of providing a 6-log reduction of microbiological spores Rapid decontamination cycle times Independent chamber decontamination cycles Integrated viable and non-viable air sampling controlled via the HMI touchscreen display CFR 21 Part 11 compliant Flexible design and chamber layouts