Sterility Test Isolators
ENVAIR offers a number of standard Isolators as well as tailor-made Isolators according to customer’s requirements, all with fully integrated H2O2 bio-decontamination systems.
In cooperation with Bioquell and Steris, the two market leaders in the field of H2O2 bio-decontamination ENVAIR has developed fully integrated systems for a number of applications including aseptic production, filling processes, sterility tests and final sterilized housings.
The constructions include unidirectional as well as turbulent air guide systems, individually decontaminated transfer chambers, mobile transfer Isolators, connections to additional aeration units and integration with rapid-gassing transfer locks.
All systems are offered with a complete validation package including Design Qualification (DQ), Factory Acceptance Test (FAT) with customer being present, Installation Qualification (IQ) and Operational Qualification (OQ). Our validation packages are acknowledged and validated by licensed and unlicensed health organizations, pharmaceutical and research organizations.
Traditional 2D drafts and 3D models form part of our engagement to make sure that we will offer the best solutions for your technical requirements including your demands with regards to the total H2O2 cycle time and to your financial budget.
The integrated H2O2 technology with our Isolators as well as a permanent particle count and viable airflow supervision can be integral part of our constructions as well, which can offer you the complete solutions.
Contact ENVAIR, we gladly will help you.