Sterilizing-grade Filter Validation
Complimentary
Learning Level: Advanced
Time: 0900 - 1000 EST
Session Length: 1 hour
The solution or liquid products intended for parenteral administration, which cannot be terminally sterilised in its final container, are sterilised by filtration through a sterile sterilising grade filter, with a nominal pore size of a maximum of 0.22 µm, that has been appropriately validated to obtain a sterile filtrate and subsequently aseptically filled into a previously sterilised container.
Various filter configurations and processes can be used to control the bioburden and nonviable particulate levels presented to the final, sterilizing-grade filter.
- One configuration is a multifilter arrangement that consists of two sterilizing-grade filters (or a bioburden reduction filter followed by a sterilizing-grade filter) connected in series (USP〈1229.4〉)
- Another configuration appropriate for prefiltration bioburden control uses two filtration steps separated in time: the liquid is sterile-filtered into a sterilized tank, where it is then held before a final, sterilizing filtration (USP〈1229.4〉)
In each of these scenarios, the bioburden and particulate levels presented to the final, sterilizing-grade filter are low and are controlled by prefiltration.
- When the process results in a consistently low and controlled prefiltration bioburden, use of a single sterilizing-grade filter is appropriate. (USP〈1229.4〉)
Irrespective of the strategy employed, validation studies should demonstrate the capability to consistently achieve the requisite levels of prefiltration bioburden and particulate level reduction and control. (USP〈1229.4〉)
According to the CGMP guidelines, the sterile filtration of liquids should be validated in accordance with relevant Pharmacopeia requirements. During filter validation, wherever possible, the product to be filtered should be used for bacterial retention testing of the sterilising grade filter.
As part of this webinar let us explore the approach on validation of sterilising-grade filter based on the global regulatory references such as ASTM, EMA, ISPE, PDA, PIC/S, USP, USFDA and WHO etc.
Learning Objectives
- Minimum requirements of a sterilising grade filter
- Filter configurations
- Upstream vs downstream
- Redundant (serial) filtration systems
- Filter manufacturing process in general
- The scale and the validation approaches
- Extractables & Leachables
- Bacterial retention challenge by using B.diminuta (ATCC 19146, >1×107 cfu/cm2), bioburden isolate and indigenous bioburden
- Responsibilities of filter users and manufacturers
- Integrity testing: Water wet and Product wet bubble point (WBP, PBP)
