Regulatory Compliance and Advanced Solutions for Aseptic Environmental Monitoring
Stay ahead of evolving cGMP requirements with expert guidance on aseptic environmental monitoring and the advanced technologies that simplify compliance.
Current Good Manufacturing Practices (cGMP) strictly mandate the continuous monitoring of viable and non-viable particulates in aseptic environments, independent of production size. Achieving and maintaining compliance—particularly in the areas of facility qualification and routine environmental monitoring—must be driven by a comprehensive, preparatory risk analysis.
This session reviews the latest global regulatory requirements, offering key insights into compliance strategies. We then demonstrate advanced technological solutions for continuous particle monitoring and cleanroom mapping, detailing how these integrated systems can enhance data integrity and support a validated, risk-based Environmental Monitoring Program (EMP).
Speakers
Christian Glosse
Associate Product Line Manager
Christian Glosse specializes in GMP services for cleanroom environments, with over 15 years of experience supporting pharmaceutical and biotechnology manufacturers. He holds a degree in Mechatronics Engineering and is a Certified Product Line Manager with advanced training in GMP compliance. Christian focuses on contamination control strategies involving compressed gases, smoke visualization studies, and ISO 14644 cleanroom classification. His background spans field service, GMP consulting, and technical sales across Switzerland and Austria. Christian plays a key role in aligning environmental monitoring solutions with evolving regulatory requirements. At Particle Measuring Systems, he contributes to the development of GMP service offerings that help life sciences companies maintain data integrity, process reliability, and regulatory compliance.
