By Markku Mäkinen, Senior Design Manager, Elomatic
Identifying the most practical approach to achieve Good Manufacturing Practice (GMP) cleanrooms and cleanroom HVAC in the pharmaceutical industry does not require an “out of the box” or innovative approach. It rests, rather, on the comprehension of and adherence to a set of basic rules that have been penned by several GMP regulatory authorities. Rules are nevertheless open to subjective interpretation and herein lie some potential pitfalls. The International Society for Pharmaceutical Engineering (ISPE) provides invaluable and much needed guidance in this regard.