Sterile filtration of drug products is one of the common methods of (cold) sterilisation considered in biopharmaceutical industries worldwide for heat sensitive formulations. It is a critical step in ensuring product sterility and drug safety for patients.
Filter qualification and filtration process validations are essential in order to meet safety and regulatory requirements for sterile drugs. Due to the rising demand for biological products, the importance of new filtration systems is increasing, from large apparatus to small single-use filters. Further, the current difficulties in the global supply chain are triggering new opportunities for membranes and filter cartridges from local manufacturers. As a consequence, the need for process-specific up-to-date procedures to properly qualify new filters is becoming more and more critical.
The guidelines currently available, such as PDA TR 26 “Sterilizing Filtration of Liquids”, establish high-level requirements and do not specify test protocols, which are left to the manufacturers’ and testing laboratories’ knowledge and experience. Worst-case conditions with respect to product characteristics and process parameters need to be assessed for each filter validation test. The experimental design should be evaluated and justified on a case-by-case basis, depending on the type of filter membrane, product features, and process conditions. Failing can lead to costly delays in getting your product to market.
Successful filter validation requires a partner with experience in properly evaluating and documenting each element of filter validation.
