Essentials of Sterilizing Grade Filter Validation

Why Should You Attend:

Sterilizing filtration, utilizing membrane filter often of 0.2 micron rating, are critical in aseptic processing. Since biologic drug products are on the rise, which cannot be heat sterilized, aseptic processing and the use of sterilizing grade filters are gaining importance. Filter manufacturers are able to supply filter qualification data, but these results are established under specific lab conditions. To be able to determine the filters performance in the application settings, appropriate process validation (a regulatory requirement) needs to be performed by the end-user of the filter.

This webinar will describe filter qualification activities performed by the filter manufacturer and the resulting data. It will also touch on the guidances mentioned, such as the FDA Aseptic Processing Guidance of 2004, EC cGMP Annex 1 and the PDA’s Technical Report #26, 2008, and the requirements set within. The presenter will follow this with a detailed, step by step description of process validation needs and why these steps are of importance.

Learning Objectives:

Webinar participants will learn about

• The essential requirements of process validation of sterilizing grade filters.
• The details of individual process validation activities.
• The “must have's” of process validation of filters.
• The difference between qualification and process validation.
• Multiple guidance documents in regard to sterilizing grade filtration, the value of the guidances and the interpretation of it.

Areas Covered in the Seminar:

• Introduction.
• Filter Qualification.
• Guidances.
• Process Validation:
  • Viability test.
  • Bacteria Challenge test
  • Chemical compatibility
  • Adsorption analysis
  • Extractables analysis
  • Particulates Product-wet integrity testing
  • Other evaluations
• Conclusion.
• Questions & Answers.

Who will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:

• Validation management
• Quality assurance and control
• Pharmaceutical and biopharmaceutical processing and manufacturing
• Process development
• Regulatory and Compliance Management
• Consultants

Manufacturers of sterile filters will benefit from this training too.

Instructor Profile:

Mr. Jornitz, has over 25 years of experience and supports the biopharmaceutical industry on a world-wide basis, in particular in process and facility design, single-use technologies, membrane filtration of air and liquids. As Immediate Past Chair of PDA, Jornitz has been part of multiple PDA task forces (TR #26, #40, #41 and#45), committee member (Awards, Journal Editorial, Strategic Planning, Chapter) and committee chair (PDA Annual 2008, Strategic Planning). He is also member of ISPE, DIA and ASTM. Jornitz is the author and co-author of over 100 scientific papers. Additionally he is author and co-author of 9 books, for example Filtration and Purification in the Biopharmaceutical Industry, and 12 book chapters on aseptic process, single-use technologies and regulatory requirements. As faculty member of PDA TRI and Compliance Online, he trains industry members and regulators on a frequent basis. He holds over 30 patents related to single-use equipment, integrity testing and filter housing designs and is the founder of Bioprocess Resources LLC. Mr. Jornitz received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished his PED at the IMD Business School, Lausanne, Switzerland.

Topic Background:

Sterilizing filtration, utilizing membrane filter often of 0.2 micron rating, are critical in aseptic processing. As soon as heat sterilization cannot be used or bioburden requires to be reduced before heat sterilization, sterilizing grade filters are installed to remove the microbial burden.

To be able to determine the filters performance in the application settings, appropriate process validation requires to be performed by the end-user of the filter. Process validation takes the fluid to be filtered into consideration and the process parameters, used during filtration. Process validation is not only a regulatory requirement, but creates assurance that the filter used is of right choice and performs as expected. Regulatory guidance documents, like the FDA Aseptic Processing Guidance of 2004 and EC cGMP Annex 1 describe filter validation requirements, the most thorough though being PDA’s Technical Report #26, 2008.

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