Essentials of Sterilizing Grade Filter Validation
Venue: Online Event
|Event Date/Time: Jun 14, 2010||End Date/Time: Jun 14, 2010|
Why Should You Attend:
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 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.
Learning Objectives :
- Learn what are essential requirements of sterilizing filter process validation.
- Learn the details of individual process validation activities.
- Learn how to differentiate between the absolute essential and useful process validation steps.
- The difference between qualification and process validation.
- Multiple guidance documents will be discussed in regard to sterilizing grade filtration.
- In essence they will learn how important process validation of sterilizing filters is and what steps are required to perform such validation.
Areas Covered in the seminar :
- Filter Qualification.
- Process Validation:
- Viability test.
- Bacteria Challenge test
- Chemical compatibility
- Adsorption analysis
- Extractables analysis
- Particulates Product-wet integrity testing
- Other evaluations
- Questions & Answers.
Who will benefit :
The following individuals or disciplines will benefit from attending this Webinar:
- 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