4/27/2023 0 Comments Helium usesFigure 1 shows the life cycle of a Pall Allegro SUS with the Pall manufacturing steps in the upper region and the SUS deployment steps at the end-user site in the lower region of the figure. The helium integrity test or integrity test for single-use systemsoccurs at the Pall site during the manufacturing of Allegro SUS. The HIT method provides the highest level of control of integrity for SUS incorporated into the most critical steps of drug substance or drug product bulk storage. Additionally, Pall can perform the helium integrity test (using Pall HIT technology) upon request for Allegro single-use (SU) assemblies. 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. This risk-based approach is recommended in the Bio-Process Systems Alliance (BPSA) guide on ‘ Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance’. A proper riskassessment should be performed to define the most appropriate risk mitigation strategy. To develop a suitable strategy for the assurance of the integrity of SUS, in addition to the SUS application-specific requirements, all the steps in the life cycle of the SUS should be considered, from its design and manufacture at the supplier to its disposal by the end-user. With SUS, the responsibility is shared between the supplier and the end-user. That is different compared to conventional reusable stainless-steel systems, where the end-user is responsible for their life cycle, from design to maintenance, including validation, routine operation tests, etc. The test can be requested for Allegro biocontainer systems, Allegro mixer biocontainer systems, and single-use filling sets.Īs single-use systems are delivered as ready-to-use systems, the SUS supplier has an increased responsibility in the design, manufacture, and validation of SUS. The size of detectable defects is correlated to microbial ingress. The helium integrity test (using Pall HIT™ technology) or single-use system leak testprovides the highest level of control that the single-use system leaving the factory is 100% integral. This strategy includes the manufacturing process and the supply chain. A suitable strategy to assure the integrity of the single-use system during the life cycle is essential. Nevertheless, patient safety, as well as protection of operator and facility must be secured. Single-use technologies have gained strong market acceptance in both clinical and manufacturing operations. Supplier high sensitivity integrity test for single-use systems used in critical applications for enhanced patient safety
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