These manufacturing processes are based on our ultra-modern zoning concept. Each zone has been meticulously designed and constructed to prevent bio-contamination. Each zone is equipped with material airlocks. State-of-the-art pass-through washing equipment has its automatic loading side in one zone and its automatic unloading side in another zone of even higher cleanliness. The process flow, gowning protocols, personnel and material flow, as well as cutting-edge automation processes all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry. To not only guarantee a trouble-free environment but also a high surveillance of the process itself, we use a sophisticated, independent monitoring system. It helps us monitor every critical element of the FirstLine™ manufacturing process, from particle measurement to air temperature and moisture levels.
All of those factors are continuously monitored by an independent monitoring system. Our validated camera inspection system scans the entire surface of all serum and lyo stoppers for the presence of visual defects while checking, at the same time, for dimensional correctness and consistency. Each individual closure also passes through an integrated metal detection system. Therefore, our new cleanroom incorporates the latest generation in camera inspection techniques, guaranteeing all items are camera inspected in a closed environment immediately prior to packaging, thus preventing any possible bio-contamination.