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Media Selection Made Easy

Webinar

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 Gisselmann is global product manager for environmental monitoring at Merck. She has three years of experience in technical support for process solutions at Merck, and a background in the food and beverage industries and in microbiology.

Tim Cser

Merck

Senior 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 seven years of experience with microbial identifications. For the plast 14 years he has worked at Merck in a variety of roles involving pharmaceutical/biotech QC microbiology. Tim has written a chapter in the PDA Environmental Monitoring book in addition to speaking and training at the PDA in Brazil.

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Merck

Research. Development. Production.

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