Glass particles, small pieces of metal and other foreign objects in the lyo product with exclusive X-ray; strobes and hairs, fibres, cracks, product splashing and contamination in the container as well as defective crimp and flip off caps with sophisticated high-performance optics: the detection reliability of the HEUFT spotter II PHS during the full vial inspection has been tried and tested in practice! But HEUFT wants more – and has again extended the range of functions of the modular linear system: it will be showcased at DUPHAT Stand 4D01 with a newly integrated laser technology for Container Closure Integrity Testing which even goes a step further than the camera-based 360° closure inspection and identifies leaking primary packaging material with an O2 content in the headspace which is too high without contact.
Headspace analysis for container closure integrity testing
Because too much oxygen could cause oxidation and impair the effectiveness of the preparation inside. And this is exactly where the new Headspace Analysis (HSA) module offers protection – it volumetrically determines the O2 content and removes vials where this is not correct just as accurately as contaminated, soiled or defective ones.
The fully equipped compact system in a container-friendly and resource-efficient straight-through arrangement manages practically without any change parts. It is suitable for use in clean room class B and has a protected online connection for, among other things, real-time transmission, the preparation and complete archiving of batch and production data and Knapp test logs as well as audit trail documentation. The HEUFT spotter II PHS fulfils fundamental FDA, GMP, GAMP5 and 21 CFR Part 11 requirements reliably – and now provides even more functionality for full drug safety with the newly integrated HSA module.