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.

Presenter

Dr. Frank Panofen

PhD, Life Science Division, Product Line Manager Microbials, Particle Measuring Systems

Dr. Panofen has a Diploma in Chemistry from the University of Bielefeld and a PhD in molecular and cell biology from the University of Osnabrück. He has expansive experience in the field of applied pharmaceutical microbiology and serves as the Sterility Assurance/Microbiology Product Line Manager at Particle Measuring Systems. Frank has been an invited speaker at international conferences including ECA and PDA, with a strong regulatory background in pharmaceuticals. He is a certified Microbiological Laboratory Manager from ECA.

Presenter

Daniele Pandolfi

Life Science Division, Global Product Line Manager, Aerosol, Particle Measuring Systems

Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization in 2015.