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