Alfa Chemistry can help you complete your sterile filter verification. Our verification services ensure a reliable production process that meets legal requirements. This provides a complete picture of the filters used in your process to make the best decisions in terms of budget, time frame, and regulatory acceptance.
Alfa Chemistry Bacteria Challenge Test
Due to our scalability, we use the same materials and formats to ensure complete process relevance, and adapt to the favorable test product volume in the sterile filter verification study:
- Particle release test
- Adsorption Research
- Go to filter verification
- Extractables and leachables verification service
- Chemical compatibility test
- Product-specific integrity testing
- Bacterial challenge test (BCT), viability test (VT) and selection of test bacteria
Learn how to benefit from Alfa Chemistry’s method of verifying sterile grade filters:
- Taking into account product restrictions and process restrictions, select the correct test filter and method
- Best-in-class simulation of actual process conditions
- Years of experience can meet various needs
Microbiological and Physicochemical Research of Filters
All regulatory agencies around the world require bacterial challenge tests. The pre-conducted survivability test determines whether the test liquid affects the survivability of the test organism. Based on this, the experts of Alfa Chemistry choose the best method for your product solution. The bacteria challenge test is conducted under customer conditions to determine the ability to retain the lowest concentration of 107 bacteria per square centimeter of effective filtration area.
Chemical Compatibility Test
Alfa Chemistry uses the worst-case process parameters to test the chemical compatibility of used filter materials with your product formulations. We use our expertise to identify potentially harmful effects and advise on changes (if necessary).
Product-Specific Integrity Testing
Alfa Chemistry supports integrity testing by standardly using your product as a wetting fluid. Product-specific integrity test specifications are determined based on measured values recommended by regulatory agencies.
Particle Release Testing
At Alfa Chemistry, we quantify the particles that may be released from the filter you use as a product liquid under the most unfavorable process conditions.
The combination of product ingredients and filter membranes will adversely affect product efficacy. In order to determine the key factors affecting the bonding process, such as temperature or pH, we use appropriate and sensitive analytical testing methods.
Basic Principles of Verification
Alfa Chemistry's Sterile Filter Validation complies with the following 3 basic principles:
- Organized and documented common sense
Systematically adopt theoretical methods for verification
- Plan according to science and risk-based regulations
The plan includes verification experiments, analysis and recording of verification data
- Act according to plan
Process verification must be completed by personnel with the necessary training and experience