P2S Magazine Issue 1 - Page 11

Cleanrooms: Manufacturing Delicate Products Safely P2S has delivered cleanroom designs for clients like Applied Medical Resources, Northrop Grumman, Hewlett- Packard and 3M Pharmaceuticals. We’ve worked on new construction, facility expansions and renovations, and our designers are experienced in industrial processes and requirements. Cleanrooms come in different shapes, sizes and functions. There are warehouse-sized cleanrooms for microprocessor manufacturing and smaller facilities for pharmaceuticals. What they all share are low levels of airborne particles achieved by filtering air coming from the outside and constant recirculation of inside air through filters. The nine ISO classes for cleanrooms refer to ISO 14644-with, Class 9 allowing the greatest number of airborne particles and Class 1 the least. Cleanrooms also come in the modular variety, which means that they can be disassembled and moved as necessary. HVAC design is critical to cleanrooms because just like labs, they need to constantly recirculate air and control the humidity within. In laboratory settings, cleanroom like facilities are found within clinical labs that manufacture medicines for trial. The quality of trial drugs is important and the FDA sets standards and requires that facilities that manufacture drugs adhere to current good manufacturing practices (cGMP). cGMP ensure that manufacturing operations are properly controlled so that products, and the safety of those ingesting them, are not compromised. 11