The sterility of a product is defined by the absence of viable and actively multiplying microorganisms
when tested in specified culture media. This is important for medical devices, pharmaceuticals, tissue materials and others because it gives assurance that the products are free from the presence of viable microorganism. We provide sterility testing which is based on ISO 11737-2:2009 guideline using direct immersion method for products in the form of solid dosage, powders, ointments and creams.
ISO 11737-2:2019; Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process