CONTAINER CLOSURE INTEGRITY
VACUUM DECAY LEAK DETECTION
Nondestructive Vacuum decay leak detection technology is a robust and reliable solution for ensuring Container Closure Integrity (CCI) for critical parenteral applications.
The principle behind vacuum decay leak testing make it one of the most simple and effective package integrity tests. A vacuum decay leak tester connects to a test chamber that is specifically designed to contain the package to be tested. The test is performed by placing a package into the test chamber, drawing vacuum on the test chamber and monitoring it for any changes in the vacuum level. If a package is defective, air or vapor will leak from the package into the test chamber causing a change in pressure. Non-leaking packages do not leak any air into the chamber, holding the chamber vacuum level constant. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.
Vacuum decay leak detection technology is flexible – systems can be designed to quickly and reliably evaluate rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Another benefit of the technology platform is that it scales from lab to manufacturing, ensuring product quality throughout the product lifecycle.
Applying Vacuum Decay Leak Detection
Vacuum decay leak detection technology is flexible – systems can be designed to quickly and reliably evaluate rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Another benefit of the technology platform is that it scales from lab to manufacturing, ensuring product quality throughout the product lifecycle.
The standard vacuum decay leak detection test method (ASTM F2338) has long been recognized by the FDA as a consensus standard for package integrity testing. The test method is also listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI – USP <1207>. With a thorough method development and validation program, quantitative acceptance criteria can be established for pass | fail determinations.
ASTM F 2338-09 (2013)
“Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method”
ZebraSci’s experienced engineers are well versed in vacuum decay leak detection and other highly sensitive CCI methods. We can guide you to the best approach for your product/package combination from parental applications to sterile barrier materials.
Contact ZebraSci today to learn more about applications for Vacuum Decay and our other solutions for Container Closure Integrity (CCI).