Selecting the right media for your aseptic process simulations
In pharmaceutical manufacturing, product safety is vital. Aseptic processing simulations or media fill tests are performed to ensure that your facility produces microbiologically safe parenteral drugs.
In this webinar, our media fill experts will give an overview of what to consider when selecting media for aseptic process simulations, in particular:
- Regulatory requirements in the US and the EU (including the changes to GMP Annex 1)
- User requirement specification (URS) for equipment and instruments
Key Learning Objectives:
- Understand what the regulations say about media fill tests
- Real world examples of problems we can face with media fill tests
- Recognize the key challenges of selecting the right media for media fill tests
- The solutions we provide to overcome those challenges
Speakers
Adèle Gisselmann
Merck
Global Product Manager Environmental Monitoring
Adèle is the Global Product Manager for Environmental Monitoring, after 3 years in Technical Support at Merck (Process Solutions) and a background in the Food and Beverage industry and microbiology.
Tim Cser
Merck
Sr. Technology Specialist
Tim Cser is a Senior Technology Specialist with Merck. Tim graduated in 1997 from Cal Poly, San Luis Obispo with a degree in Microbiology with an emphasis on Industrial Microbiology. Tim started his career with Clorox working on antimicrobial effectiveness studies. He continued his career at Biolog where he gained 7 years of experience with microbial identifications. For the last 14 years he’s worked at Merck in a variety of roles involving Pharmaceutical/Biotech QC Microbiology.
Microbiological testing
- Media fills
Durata:28min
Lingua:English
Sessione 1:tenuto September 29, 2020
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