Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

2Scope / Description

This document specifies requirements for the enumeration and microbiological characterization of viable microbial populations on or in medicinal products, components, raw materials or packaging and provides guidance on these requirements. NOTE 1 The nature and extent of the microbiological characterization will depend on the intended use of the bioburden data. NOTE 2 See Annex A for guidance on clauses 1 to 9. This document does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on the inactivation of viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022. This document is not intended for microbiological monitoring in medicinal product manufacturing environments.