Merck webinar: Environmental monitoring in aseptic manufacturing

27-Nov-2018

Environmental monitoring in aseptic manufacturing – regulatory requirements for culture media and validation, will cover the various GMP guidance, ISO Norms or pharmacopoeia regulatory demands for environmental monitoring culture media used in aseptic areas

An environmental monitoring program provides important information about the hygiene status of critical aseptic processing areas, and the associated clean rooms. Regulatory requirements for environmental monitoring are described in several guidelines including GMP, ISO and various pharmacopoeia. For both air monitoring and surface monitoring the appropriate culture media with the correct formulation is required, and it must be validated for this application.

Our webinar focuses on culture media used in aseptic manufacturing areas and will cover general regulatory requirements for:

Passive and active air monitoring
Surface monitoring
Personnel monitoring

In addition, our expert Dr. Anne-Grit Klees will talk about inactivation of antimicrobial agents like disinfectants or antibiotics, which may inhibit the growth of microorganisms in the media. Finally, she will present validation data of TSA media from a supplier. Key topics covered: