Sterilizing Filter Process Validation - Essential Requirements
Overview:
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.
Since an increasing fluid area 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 and 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.
The webinar will describe filter qualification activities performed by the filter manufacturer and the resulting data. It will also touch on the guidances mentioned and the requirements set within. Followed by a detailed, step by step description of process validation needs and why these steps are of importance.
Why should you attend:
- Participants will learn what are essential requirements of sterilizing filter process validation.
- Participants will learn the details of individual process validation activities
- Participants will learn how to differentiate between the absolute essential and useful process validation steps.
- Participants will also the difference between qualification and process validation.
- Multiple guidance documents will be discussed in regard to sterilizing grade filtration
- In essence You will learn how important process validation of sterilizing filters is and what steps are required to perform such validation.
Areas Covered in the Session:
- 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:
- Validation management
- Quality Unit Vice Presidents, Directors and Managers
- Vice presidents, Directors and Managers of pharmaceutical operations
- Process development Management and Technicians
- Regulatory and Compliance Management
- Consultants