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Package integrity testing is critical for CGM devices as any breach in packaging could compromise sterility, potentially leading to infections or product degradation. Packaging for CGMs typically includes materials like Tyvek® Poly or Foil pouches, and defects such as cold seals, channel leaks, or occlusions can occur during manufacturing or sterilization. Traditional visual inspections often fail to detect microleaks, which are capable of allowing harmful microorganisms or gases to penetrate the packaging.

 

This is where Vacuum Decay technology can be applied. Vacuum Decay technology is an FDA-recognized leak detection technique that can be used for CCI testing of high-risk package applications. The non-destructive nature of this process provides a greater understanding of the packages and reduces waste. Vacuum Decay technology is capable of sensitively testing leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials and is proven to provide repeatable, reliable and quantitative test results.

PTI’s VeriPac Vacuum Decay technology is an ASTM-approved, FDA-recognized test method with proven capabilities to provide reliable, reproducible, repeatable, and accurate quantitative results. It is a non-destructive container closure integrity test (CCIT) test capable of detecting leaks in a single-digit micron range while accommodating multiple packaging types including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Considered as a practical alternative to destructive testing methods like water bath or dye ingress, Vacuum Decay technology eliminates subjectivity, reduces waste and cost and is proven to provide a short-term return on investment. The VeriPac test systems detect critical packaging failures reliably and reveal valuable information on the packaging process.

In the medical device industry, where patient safety is paramount, ensuring the integrity of packaging is crucial. For CGMs, which are vital for diabetes management, any compromise in packaging could lead to severe health consequences. Vacuum Decay Technology provides an effective, non-destructive method for detecting leaks and maintaining the integrity of CGM packaging, thereby ensuring product safety and sterility. As this technology continues to evolve, it stands to play an even greater role in enhancing the reliability and safety of medical devices worldwide.