This paper written by Mark Hallworth, one of the ISO TR 14644 21 committee members, discusses why this new technical report was released, the implications, and next steps for practical application. Complete with explanatory diagrams and a decision tree.
The purpose of the Growth Promotion Test (GPT) is to determine the appropriateness of the culture media to be used in environmental monitoring sampling. The medium is challenged with a small number of microorganisms to assure the nutritive properties, functionality and media quality are adequate for the detection and enumeration of microbial contaminants.
Understanding critical air patterns and their impacts is paramount to controlling an environment and is a crucial activity in adhering to the relevant regulations. Scientific demonstration is the basis of pharmaceutical GMP regulatory compliance, and the best way to demonstrate air patterns is through airflow visualization studies (also known as smoke studies). If unidirectional airflow (UDAF) is used as a tool for mitigating the risk of contamination, a company must demonstrate its effectiveness through such studies.
Particle Measuring Systems (PMS) recently hosted a webinar about the new Annex 1 2022 Revision. This easy to read compendium for quick consultation consists of questions received in conjunction with the webinar along with questions from years of supporting our customers in their compliance journey. Questions are answered below by industry expert Mark Hallworth.