Effective Compressed Gas Environmental Monitoring: Particles and Microbials

Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Environmental monitoring of particles and microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components.

Absence of particle and microbial (VNV) 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.

This on-demand webinar covers regulatory guidelines as well as providing practical solutions for compressed gas environmental monitoring.

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Ready to start monitoring your compressed gases? Particle Measuring Systems has a variety of solutions for both particle and microbial monitoringLearn more here. 

MM with CG Kit
Dr. Frank Panofen
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

Sr. Daniele Pandolfi

Gerente Global de Linha de Produtos, Software/Sistemas/Serviços, Particle Measuring Systems, Inc.

Daniele Pandolfi é o Gerente Global de Linha de Produtos de Software/Sistemas/Serviços da Particle Monitoring Systems, Inc. Com mais de 11 anos de experiência em contador de partículas e controle de contaminação em salas limpas, ele se concentra em construir e manter relacionamentos fortes com os clientes. Ele ajudou muitos usuários de salas limpas a resolver seus problemas de cGMP.