Important requirements when validating sterilizing grade filters

Speaker

Instructor: Maik Jornitz
Product ID: 701110

Location
  • Duration: 60 Min
This sterilizing grade filter validation training will provide valuable assistance in validating sterilizing grade liquid filters within the pharmaceutical and biotech processes.
RECORDED TRAINING
Last Recorded Date: Dec-2010

 

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Why Should You Attend:

Sterilizing grade membrane filters are used in many applications within the biopharmaceutical industry, most critically though as a point-of-use filter before the filling process. These filters require appropriate process validation to verify the filter performs as specified, for example retaining microbial contaminants and/or avoiding release of leachables or particulates.

In this webinar multiple validation process steps will be described and discussed in regard to methodology and criticality. These validation processes include, viability, product bacteria challenge testing, extractable/leachables testing, unspecific adsorption, particle release, chemical compatibility and product wet integrity testing.

Areas Covered in the Seminar:

  • What is filter qualification, what is filter validation.
  • Regulatory requiremnents validating sterilzing grade filters.
  • Various validation requirements and processes.
  • Practical experiences with filter validation.
  • Documents required.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their sterilizing grade liquid filters within the pharmaceutical and biotech processes. The employees who will benefit include:

  • End-users of sterilizing grade filters
  • Validation manager or specialists
  • Regulatory manager or support
  • Quality assurance manager
  • Regulatory agency personnel
  • Consultants

Instructor Profile:

Maik Jornitz, is Group Vice President Marketing at the Sartorius Stedim Biotech Inc.. With over 20 years of experience, Mr. Jornitz supports the biopharmaceutical industry on a world-wide basis, in validation, integrity testing, membrane filtration of air and liquids. As Chair-Elect of PDA, Jornitz has been part of multiple PDA task forces, committee member and chair. He is also member of ISPE, DIA, ASTM and ALSAC. Jornitz is the author and co-author of close to 80 professional papers, 8 books and 6 book chapters. As faculty member of PDA TRI he trains industry members and regulators on a frequent basis. He holds several filter related patents and is the founder of Bioprocess Resources LLC.

Mr. Jornitz received his Diploma in Bioengineering at the College for Advanced Technology in Hamburg, Germany and accomplished his PED at the IMD Business School, Lausanne, Switzerland.

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