SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.
During this facility’s ACF conversion, an extensive cleaning conversion protocol was completed and systems and procedures were reviewed and modified. This process addressed several comprehensive factors, including:
• Cleaning protocol and documentation
• facility analysis of air, personnel, equipment, and process flows
• raw material procedures—from receipt, inspection, sampling, quarantine, and storage to release
• standard operating procedures review against ACF requirements, with changes implemented to cover product sampling, personnel and product flows, and cleaning
• personnel training records review and pertinent training updates before ACF conversion
• risk analysis performed on all equipment and components used in ACF areas
• ACF status and manufacturing information collected on all raw materials
• contamination remediation plan instituted for any system breech, including provisions for equipment decontamination, cleaning procedures, personnel and process flows, timelines and business continuity planning.