Helene Pora, Vice President of Single-Use Technologies
Going with the Flow: Ensuring the Integrity of Single-use Systems
Single-use technologies for formulation and filling have revolutionized the clean manufacturing of small molecule and biologic pharmaceuticals, cutting costs and making production lines simpler, safer and more cost effective. However, these single-use systems can be damaged during storage, installation or use. To protect the end users, and give them confidence in the system, manufacturers need a simple, robust and reliable point-of-use test, confirming that there are no leaks before and/or after use.
There are a number of key user needs for a point-of-use leak test:
- It needs to be simple to fit and must maintain the sterility of the system
- It should be fast, so that it doesn’t hold up the manufacturing process
- It should have a small footprint, so that it does not affect the layout of the production line
- It should be flexible, in order to be able to test all configurations of systems
- It should be validated and comply with CFR21 part 11 for audit purposes
Pall’s Palltronic Flowstar LGR test instrument, specifically designed for use in the vaccines, biotech, and pharmaceutical markets, meets all these criteria. It allows true point-of-use leak testing of single-use systems up to 200 L, including testing the integrity of the filters within the system, in only around 15 minutes. It is small and easy to use, and can be connected into the single-use systems via Stäubli fittings without breaching the sterility, and without the risk of additional handling.
The flexibility of the Palltronic Flowstar LGR test instrument means that it can test single-use systems with and without biocontainers, using air or nitrogen (for oxygen-sensitive applications). Their different test pressure increases its sensitivity, with high-pressure tests for simple tubing sets, and low pressure for 3D and 2D biocontainer systems. Finally, the test instrument is fully validated and CFR 21 part 11 compliant with a full audit trail. It allows end users to test endless configurations of single-use systems and filters, with a single test device.