Clean rooms for the pharmaceutical industry comply with specific requirements in terms of contamination control. In fact, several productive processes in the pharmaceutical industry need to be completed in aseptic environments, which are characterized by strict control needs in terms of environmental parameters.
Pharmaceutical clean rooms are designed to mantain a “controlled level of contamination” of the air through cutting-edge air purification systems. These systems have to guarantee a level of contamination almost equal to zero and specific instruments are needed to measure these levels.
From a legislative point of view, each pharmaceutical clean room is designed and produced in compliance with Good Manufacture Practice established by GMP-EEC in the European Community and by GMP-FDA in the United States. GMP (Good Manufacture Practice) identify and list the requirements of the environments in which drugs are produced (e.g. threshold values of microbiological and particle concentration), as well as indications for the staff and characteristics of the environments.