Sterilizing Filters in The Pharmaceutical Industry: Selection, Testing, And Validation

Event Information
Product Format
Prerecorded Event
Lori Herz, Ph.D.
60 Minutes
Product Description

Sterilizing Filters’ Efficacy: Learn the Use, Selection, Testing, and Validation

Sterilizing filters are essential elements in the manufacture of sterile drug products, and in cell culture and fermentation processes. Since these filters are used to ensure that products are free of microbial contamination, they play a vital role in the delivery of safe, quality medicines for patients.

Focus on both the technical and compliance aspects of the use, selection, testing, and validation of sterilizing filters with our expert Lori Herz. Our expert will begin with an overview of how filters work and what types of filtration media are typically used in the industry.

Next, models pertaining to pore size, filtration rates and clogging, and scale-up approaches will be presented, including specific examples of how to size filters and determine the maximum volumetric throughput (Vmax). The focus will then shift to bacterial retention challenge tests, which are the most critical component of filter validation, because they ensure sterility at process conditions. Then, filter integrity testing, which is another aspect of filter validation and an important step during routine manufacture, will be discussed.

The final topic in the conference will be extractables testing, which is needed to ensure a high quality pharmaceutical product. Everything becomes easy when explained with the help of powerpoint slides of presentation, practical examples of how to size and test filters and references for additional information on topics presented.

Here are few topics covered in the session:

  • How filters work
    • Retention mechanisms
  • Models of flow in filtration
    • Pore size, flow rates and clogging, and scale-up approaches
    • Filter sizing, Vmax
  • Filter validation – bacterial retention studies
    • Model for bacterial retention
  • Filter integrity testing
  • Extractables studies
  • Regulations and guidelines

Who should attend?

  • Process development scientists and engineers
  • Manufacturing engineer
  • Production supervisors and managers
  • Quality assurance and quality control leaders

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About Our Speaker

Lori Herz - Pharma Training Expert

Lori Herz, Ph.D. is currently a Professor of Practice of Chemical Engineering at Lehigh University. She is the Associate Director of the Bioengineering Program at Lehigh, where she teaches the Metabolic Engineering and Biotechnology Laboratory courses. Additionally, she is affiliated with the Integrated Product Development program, for which she advises student teams working on their capstone design projects.

Prior to joining Lehigh, Dr. Herz worked at Bristol-Myers Squibb...   More Info
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