Be prepared for Annex I: Continuous Microbial Air Monitoring in Clean Room Environments Application Note
Environmental monitoring is an important part of quality assurance for the production environments of sterile pharmaceutical products.
EU GMP guidance calls for an air sample volume no less than 1 m³ to be taken per sample location, but for an 8 hour work shift, this volume is too low to reliably judge the air quality of the manufacturing environment. One approach to improving product safety is the implementation of a continuous air monitoring system covering the complete production process.
In this study, we qualify gelatin membranes manufactured by Sartorius Stedim Biotech GmbH for continuous air monitoring in industrial pharmaceutical production environments throughout an 8 h work shift.