Basic requirements for clean rooms in pharmaceutical production
Cleanroom requirements for aseptic pharmaceutical and terminally sterilized pharmaceuticals differ. The filling / filling process (critical process) in the production of non-terminally sterilized pharmaceuticals requires a clean area “A” surrounded by a clean area of class “B” to minimize the risk of contamination of the finished product with particles and microorganisms.
For pharmaceutical products that undergo terminal sterilization, the “Rules for the organization of production and quality control of medicines” establish less stringent requirements. In particular, filling with terminally sterilized products can be carried out in a class C production environment, however, if there is an increased risk of contamination (if the filling operations are slow or the packages have a wide neck, or they need to be kept open for more than a few seconds before sealing), the filling is so the same should be carried out in a clean area of class A (but with an environment of at least class C).
What is the purpose of certification of clean rooms in the pharmaceutical industry?
In 2009, сommittee of Ukraine for Regulatory Policy and Entrepreneurship (State Committee for Entrepreneurship) approved Licensing Conditions for the implementation of economic activities for the production of medicines, wholesale, retail sale of medicines (Licensing Conditions). The production of medicines and pharmaceutical substances must be carried out in clean rooms with proven qualifications. In the production of medicines, the concept of “sterility” is of particular importance, meaning “the absence of living microorganisms”. Technological operations in the production of drugs, both terminally sterilized and produced under aseptic conditions must be carried out in clean rooms or clean areas to ensure sterility in pharmaceutical production.