Effective Compressed Gas Contamination Monitoring: Particles and Microbials
Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components.
Absence of viable and non-viable contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. Moreover, compressed gases can be viewed as critical utilities in pharmaceutical Industry when either in direct product contact or directly entered into the clean room environment.