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The ability of container closure systems to maintain a sterile barrier against potential contaminants that could lower the quality of the finished product can be understood as container closure integrity. External contaminants may enter the product through even the smallest leak or breach of the sterile barrier, impairing its capacity to perform as expected. Despite being popular leak testing techniques, dye ingress and microbial ingress have been shown to produce results that are often inaccurate and subjective. Deterministic test methodologies that can be controlled, calibrated, and provide a firm determination of CCI have therefore been encouraged by regulatory bodies.

Vacuum Decay is a non-destructive container closure integrity testing (CCIT) method for detecting leak paths and package integrity. The test method is simple in principle and challenges container integrity based on fundamental physical properties. This test provides a quantitative result that is accurate, repeatable, reproducible, and reliable with a pass/fail determination.

Our line of non-destructive VeriPac package testing equipment is backed by the tradition of excellence and performance reliability that PTI brings. The FDA acknowledges the standard Vacuum Decay leak test method (ASTM F2338), which was created using PTI's VeriPac instruments, as a consensus standard for testing container closure integrity (CCI). The test method is referenced in the United States Pharmacopeia Chapter on CCI and listed in ISO 11607 (USP Chapter 1207). The test is conducted by drawing vacuum on a package inside of a test chamber, and the vacuum level is checked for any decay that might signify a leak. The technique has established itself as a non-destructive substitute for the water bath leak test. By avoiding product waste for a leak test, it offers significant savings and, for many products, achieves return on investment in less than six months.

Industry Applications:

1. Pharmaceutical Industry

Pharmaceutical manufacturers prioritize quality control and package integrity because defects in pharmaceutical product manufacturing can directly affect drug quality. Even minor defects in the packaging or container may allow outside elements or contaminants to enter the drug. A manufacturer prioritizes implementing the proper container closure system because it affects both the product and the patient. CCI testing is a non-destructive package inspection technology for detecting leaks and avoiding potential contamination. The regulatory bodies take CCI's negligence very seriously. The guidelines support deterministic, dependable test methods for measuring industry-wide quality standards.

2. Food and Nutrition Industry

Packaging is crucial to today's food and nutrition industry. Packaging serves a variety of purposes, including product safety, brand awareness, product promotion, product protection and product delivery. Food and nutrition products are packaged so that they stay fresh for the entire shelf life. However, the challenges associated with packaging food and nutrition products have increased due to frequent innovations in packaging formats and the move towards sustainable packaging materials.

In order to ensure that the products are free from any type of contamination or defect, manufacturers are encouraged to perform appropriate package integrity tests. Various Container Closure Integrity Testing techniques are now available on the market to guarantee the quality and sterility of packages for the duration of their shelf life or until they are delivered to the consumer. Vacuum Decay technology and Airborne Ultrasound technology, among other methods, are very useful in food and nutrition package inspection.

Benefits of Vacuum Decay Technology

• Non-destructive, non-invasive, no sample preparation
• Accurate, reliable, repeatable results
• Supports sustainable packaging and zero waste initiatives
• FDA recognized standard for package integrity testing
• ASTM test method F2338