Cleanliness is a critical factor in the pharmaceutical industry as well as related sectors such as biotechnology, medical devices, hospitals, and diagnostic centers. This applies to both warehouse clean rooms and at the loading dock. In fact, the global clean room market for these industries is now more than $3 billion (USD) with expectations to grow 5.1% through 2025. The pharma industry accounts for nearly half of that $3 billion.
Every clean room has a controlled level of contamination determine by the number of particles per cubic meter at a specified particle size. Regulatory standards differ by application, but the pharma industry clean rooms are generally in the range of ISO 5, 6, 7 or 8. In addition, Current Good Manufacturing Practices (CGMPs) start deep in the facility with individual rooms being pressurized in a strategic manner. As each room is pressurized, particulates are forced out into the hallways and ultimately out to the non-white areas like the loading dock where the U.S. Food and Drug Administration (FDA)* enforces its own set of standards and requirements.
Contamination control on the loading dock requires all dock levelers, doors and curtain walls to have tight seals. The industry also demands easy wash down capabilities for critical control points, such as the door openings and fabric walls. In addition, the aesthetic at the loading dock has to match the state-of-the-art pharmaceutical equipment of the rest of the facility.
At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology and the latest trends in the industry.
Learn more by downloading the "Essential Guide to: Clean Rooms and Clean Areas."European Medicines Agency (EMA)