Centralized Facility For Sterility Testing

The Sterility Test Laboratory of Bio-Assay Division is a Central Facility equipped to test the various Biologicals referred to it for sterility testing and NABL Accredited (Certificate No. TC-7725) in accordance with the standard ISO/IEC 17025;2017 in the field of biological Testing . The various laboratories of the Institute which are currently referring its samples are Recombinant Products, Blood Products, Enzyme and Hormones, Viral Vaccine and Bacterial Vaccine Laboratories.

The products referred are tested by Direct Inoculation or Membrane Method (Closed Sterility Test Method) as per IP, USP, EP and other pharmacopoeia and as advised by the referring laboratory.

Environmental microbiology lab : For isolation & biochemical characterization of Clean room environmental isolates and handling & maintenance of reference strains of bacterial & fungal strains has been establishment.

The Sterility Testing Laboratory of the Bio Assay Division was made operational in April 2009 in its designated location, and has since tested Biological samples from the different labs.