During recent years more single-use systems are employed for production of sterile medicinal products and in up- and down-stream of biotechnological production processes. single-use systems can be individual components or assemblies of bags, filters, tubes, aseptic connectors, valves or sensors and are supplied sterile or non-sterile. Compared to re-useable equipment, with the use of single-use systems the number and complexity of manual interventions is reduced, no cleaning validation is required, and with intrinsic aseptic connectors the risks related to aseptic connections is mitigated. However, single-use systems are critical components for the medicinal product’s quality and therefore require profound qualification of the single-use systems manufacturers.
Single-use systems manufacturers have usually established quality management systems according to ISO 9001:2015 or ISO 13485:2016. Since 2021, blue inspection has performed several audits of different types of single-use systems manufacturers. Our auditors are familiar with the medicinal product manufacturer’s requirements with regard to function, integrity, extractables, leachables, particles, endotoxins, bioburden resp. sterility and reliability of supply and perform risk-based audits according to your requirements. For sterile single-use systems the audits cover also the validation of the sterilization process and qualification of the sterilization service supplier by the single-use systems manufacturer.
