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Sterile Filtration Process Control: Meeting Regulatory Expectations

Sterile filtration is a pivotal process step in pharmaceutical manufacturing to ensure the sterility of injectable drug products. It eliminates microorganisms and particulates while safeguarding the integrity of a final product. Effectively managing and monitoring the sterile filtration process requires meticulous attention to manufacturing controls and encompasses key parameters such as flow rate, temperature, use time, and pressure. Pressure emerges as a critical factor, necessitating oversight to validate the efficacy of a filtration system and uphold the stringent standards of regulatory bodies such as the US Food and Drug Administration (FDA) and the European Commission.