Helium Integrity Testing (HIT™)
As reliance on single-use technologies has grown in the bioprocess industry, so too has concern about integrity. Drug products acrue value at an exponential rate as they move downstream, with batch values reaching into the millions of dollars. Batch failure due to leakage or sterility breach represents an unacceptable financial loss, and so users are increasingly seeking out new ways to ensure the integrity their single-use systems is absolute.
As a key provider of single-use vessels, bags and systems, ATMI has developed a Helium-based integrity testing system to help ensure higher integrity confidence in its single-use bags, vessels and systems.
ATMI is an acknowledged technology leader in the manufacture of single-use bioprocess systems and consumables. Its innovative disposable technologies, best-of-breed polymer films, ultra-clean ISO Class 5 manufacturing conditions and whole-bag integrity testing set a high bar for the single-use industry. Today, ATMI is raising the bar even higher with the introduction of Helium Integrity Testing (HIT™)
ATMI's patent-pending HIT technology, allows each ATMI 2-D Bioprocess Vessel (BPV) to be tested for defects that can compromise sterility but are too small to be detected by conventional pressure-decay methods.
The test protocol involves placing each finished BPV assembly into an enclosed test chamber, evacuating the chamber air to create a vacuum, and then introducing a measured quantity of helium gas into the BPV. The helium-filled BPV is then held for a fixed time while the surrounding vacuum is monitored for leaking helium using a sensitive mass spectometer.
As with ATMI's pressure-decay method, the new HIT™ technology is a "whole-bag" test; the entire finished bag, including tubing and connectors, is tested at the end of the manufacturing process. This approach is much more likely to detect defects than less satisfactory "chamber-only" testing approaches.
Independent third-party laboratories performing bacterial challenge testing on single-use bags have concluded that bacterial ingress can occur through pinholes as small as 15µm, whereas pinholes at or below 10µm present little or no risk or sterility breach.
Conventional whole-bag pressure-decay integrity testing is typically only sensitive enough to detect pinholes down to about 90µm. To gain more sensitivity, it is necessary to limit the testing to only the bag chamber, and to work at pressures and test durations that are ill-suited to in-production release testing. In practice, this limits the usefulness of pressure-decay integrity testing.
In contrast, ATMI HIT™ technology has been validated for reliable detection of pinholes as small as 10µm, even in the contect of an in-process whole-bag product release test. This makes HIT™ the method of choice for testing BPVs destined for the most critical applications such has high-value API, final fill and cell therapy.
More extensive HIT™ validation data can be made available to ATMI customers during quality audits under a confidential disclosure agreement (CDA) - please contact your ATMI representative for details.
ATMI 2-D BPVs up to 50L size are now available as HIT™-tested variants. Standard configurations are available, or custom assemblies can be tailored to end-user requirements. Contact your ATMI representative to discuss your specific needs.
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