Facility Monitoring (FMS) Archives

Microbial Contamination Monitoring and cleanroom data management

Contamination Control Strategies for Innovation and Regulatory Compliance FAQ

Particle Measuring Systems (PMS) recently hosted a webinar titled Contamination Control Strategies for Innovation and Regulatory Compliance to explain how the implementation of a CCS attempts to address the varied causes of contamination and compromised sterility. 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 Ugo Omeronye .

Isokinetic Particle Sampling in Unidirectional Flow

A cleanroom with unidirectional airflow utilizes a controlled, steady velocity of air in parallel streamlines that move in one direction to minimize the potential movement of contamination. Unidirectional cleanrooms are typically designed using laminar airflow hoods that direct the air, and the airflow is designed to wash particles from a potential contamination source away from the process risk before being exhausted from the process area.

Bacteria to Consider for the Growth Promotion Test: Should Anaerobic Cultures Be Included?

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.

Airflow Visualization Studies: The Impact of Annex 1 (2022) on Sterility Assurance

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.