With the revised EU GMP Annex 1 now in force, pressure on QA teams and compliance leaders has intensified…
Scaling CCI Testing Without Sacrificing Throughput
In fast-paced pharmaceutical manufacturing, testing container closure integrity (CCI) is essential for product safety, regulatory compliance, and brand reputation…
Legacy Sterilisers Keep Failing Leak Tests? Here’s What You Can Do About It
If your sterilisation cycles keep getting interrupted by failed leak tests, you’re not alone, and you’re not imagining it…
How to Design a Flexible Leak Testing Process for Rapid Device Innovation
Innovation in medical device development is moving faster than ever. As timelines shorten and product iterations accelerate, quality processes must keep pace, especially when it comes to leak testing. Whether you’re launching a next-gen drug package or refining an existing assembly,…
Non-Destructive Leak Testing for Medical Devices: Myths, Methods, and Must-Haves
For manufacturers of sterile medical devices, leak testing plays a critical role in maintaining patient safety, meeting regulatory requirements, and delivering consistent product quality. But despite its importance, leak testing is often misunderstood, misapplied, or underestimated, especially when it comes to…
Vacuum Decay vs. Helium Leak Testing: Which Is Best for Your Pharma Packaging?
When it comes to packaging for pharmaceuticals and sterile injectables, leak testing is not optional. Whether you are producing parenteral vials, syringes, plasma bags or blister packs, a compromised seal can put patients at risk and result in product recalls, failed…