Pre-sterilized single-use assemblies containing redundant filter are commonly used for final filtration and filling operations where maintaining sterility is critical to assuring drug safety for patients. A novel single-use redundant filtration (SURF) assembly with Millipak<sup>®</sup> Final Fill (MPFF) filters as primary and redundant filters is designed to minimize the product losses at the final filtration stage. Multipurpose valve port of the MPFF filter enables aseptic connections for venting, sampling and connecting air-line for the purpose of integrity testing. As a result, the assembly contain less parts and connections, and has significantly lower hold-up volume compared to the traditional assemblies. Additionally, a method was devised to perform the integrity test of both primary and redundant filters using the valve port eliminating the need for filter(s) or bag(s) downstream of the redundant product filter traditionally installed for collecting test liquids and venting test gases. This method and accompanying results will be presented in detail to illustrate benefits of the novel assembly.

Single-use redundant filtration (SURF) assembly and novel method of integrity testing

ACS Fall 2021

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