Industrial perspective on validation of tangential flow filtration in biopharmaceutical applications. Technical Report No. 15. Parenteral Drug Association. Biotechnology Task Force on Purification and Scale-up.

Abstract

Validation of tangential flow filtration is required to ensure the process delivers a product of consistent quality, safety, and efficacy. A thorough and sound validation program not only satisfies regulatory requirements, but also provides a valuable source of information which facilitates development of future processes, training of production personnel, and trouble shooting for the validated process. Validation of TFF shares many common elements with validation of other traditional operations and equipment. Existing personnel and procedures should be readily adapted to execute the TFF validation protocols. IQ's and OQ's will most likely follow familiar formats. In performance qualification, key areas needing attention include: assessment of compatibles, testing of parameters affecting membrane retention and selectivity, cleaning, sanitization, and membrane lifetime. Finally, the hallmark of a sound validation program is the quality of its scientific approach and its congruence with the definition of validation contained in the 1987 guidelines (6).