Related Experiment Videos
Validation of sterilizing grade filtration.
1Sartorius Corp., Edgewood, NY 11717, USA. maik.jornitz@sartorius.com
Developments in Biologicals
|November 19, 2003
Summary
Sterilizing grade filter validation now requires rigorous Bacterial Challenge testing with drug products, moving beyond past methods. Comprehensive filter qualification includes viability, extractable, adsorption, and compatibility studies for biopharmaceutical applications.
Area of Science:
- Biopharmaceutical Manufacturing
- Filtration Technology
- Quality Control
Background:
- Past validation of 0.2-micron sterilizing grade filters is under scrutiny by the FDA.
- Bacterial Challenge tests previously conducted are now viewed as filter qualification, not full validation.
Purpose of the Study:
- To outline comprehensive filter validation requirements for the biopharmaceutical industry.
- To emphasize the necessity of updated validation protocols for sterilizing grade filters.
Main Methods:
- Performing thorough Bacterial Challenge testing using the actual drug product under process conditions.
- Incorporating viability testing to establish appropriate Bacterial Challenge test methodologies.
- Considering additional evaluations such as extractable studies, adsorption, and chemical compatibility tests.
Main Results:
- Filter validation necessitates a more in-depth approach than previously implemented.
- The updated approach ensures greater assurance of filter efficacy and product safety.
Conclusions:
- Comprehensive filter validation is critical for biopharmaceutical liquid filtration.
- PDA Technical Report #26 provides essential guidelines for robust filter validation and filtration considerations.