This application note breaks down the latest Annex 1 updates on cleanroom classification, qualification, and environmental monitoring. Learn what’s changed, what’s expected, and how to stay compliant in sterile manufacturing environments.
👉 Download the full guide to align your processes with Annex 1 Rev 12.
Modern manufacturing frequently requires clean environments that are designed, constructed, and sustained to enable the highest yields possible while also hitting predictable throughput targets. This commonly involves achieving a specified cleanroom classification to establish the level of cleanroom performance, and subsequent sustaining efforts that are efficient and nimble. Having the right particle detection equipment for this application is necessary to accomplish these tasks.
Mass-produced pharmaceuticals have come far since the industrial manufacturing of synthetic drugs at the end of the 19th century with rapid advancement in technology, process control, and sterility requirements. Yet even as improvements to Pharma develop, recalls still occur with regularity and their significant impact on both the manufacturer and consumer are why worldwide regulation of the industry is so enforced. Environmental monitoring (EM) is one facet of the greater picture of current good manufacturing practices (cGMPs) that has been standardized for the safety of human health.
Answers to questions asked during the webinar “Considerations and Steps for Building a Contamination Control Strategy”. Many questions were asked about contamination monitoring requirements in cleanrooms and sampling placement pertaining to process design.