Single-use technologies have gained strong market acceptance in both clinical and manufacturing operations, even in the most critical processing steps involving highly purified sterile drug substances or drug products. To reduce the risk of potential loss of integrity of single-use systems (SUS) and to ensure patient safety, drug manufacturers perform risk assessment and develop strategies for the control and assurance of integrity of SUS in partnership with their suppliers.
For the SUS applications considered as the most critical, drug manufacturers may request an extremely sensitive and non-destructive test at the SUS supplier’s manufacturing site, for Container Closure Integrity (CCI) assurance.
Quality by Design (QbD) principles, junction tests, visual inspection, quality control tests and validated processes are used for all Pall manufacturing procedures to ensure robustness and integrity of manufactured SUS. For SUS applications requiring a very high level of assurance of integrity of their SUS, Pall can perform a helium integrity test upon request for Allegro single-use (SU) assemblies. The HIT platform provides the highest level of control of integrity for SUS incorporated into the most critical steps of drug substance or drug product bulk storage.