Building An Effective Contamination Control Strategy For Sterile Filtration

Contamination control strategy (CCS) is not a new initiative. However, the current expectation is that CCS becomes a single point of reference that helps define critical control points through data-informed risk assessment, and ultimately to demonstrate a state of process control. In addition, CCS is expected to be a living document, with periodic reviews that drive continuous improvement to further reduce the risk of contamination based on increasing process knowledge.

Final sterile filtration plays a critical role in aseptic manufacturing. It is important that end-users understand factors to consider when executing a CCS for sterile filtration and the types of risk assessments that should be conducted.

Here, we describe factors to consider for final sterile filtration throughout product development, including filter selection, integrity testing, and filter validation. In addition, we discuss considerations for performing pre-use post-sterilization integrity testing (PUPSIT).