Evaluating Container Closure Integrity using Vacuum Decay Technology
Drug quality and efficacy are greatly influenced by the way they are packaged. For the duration of the product’s shelf life, sterile items and moisture/oxygen-sensitive medications need effective barrier protection from biological contamination, water and oxygen ingress. Otherwise, negative outcomes might happen. The main sources of contamination — humidity, oxygen, or microbiological ingress — can affect the stability of the medicine throughout the course of the product’s life cycle. High sensitivity container closure integrity tests are necessary to prevent the risks of stability failure of extremely moisture sensitive pharmaceuticals or the risk of biological infiltration of sterile medications.
USP 1207> describes CCIT technologies and categorizes them as deterministic or probabilistic. The USP Chapter 2 “Package integrity evaluation — sterile products” was updated in 2016, calling into question the use of traditional methods such as dye testing or microbial challenge testing. Traditional methods are described as having probabilistic outcomes with some uncertainty in the results, making such methods difficult to quantitatively validate for the detection of critical leaks.
When combined with a risk-based strategy, deterministic CCIT methodologies based on non-destructive analytical tests can produce science-based CCI data that allows for well-informed decisions for a CCIT strategy in commercial manufacturing. Vacuum Decay technology, Airborne Ultrasound technology, and High Voltage Leak Detection (HVLD) technology are a few examples of deterministic CCI test methods. We shall go into detail on Vacuum Decay technology in this blog.
CCI Testing using Vacuum Decay Technology
A non-destructive method for testing the container closure integrity, Vacuum Decay focuses on package integrity and leak path discovery. In essence, the test procedure is simple and questions container integrity in light of key physical characteristics. The technique has proven to be a non-destructive alternative to the water bath leak test. Because there is no product wasted during a leak test, it saves money significantly and generates a return on investment in under six months for many products.
Vacuum Decay has been verified as the most practical and sensitive vacuum-based leak test method. A reliable and accurate quantitative result and a pass/fail determination are produced by the test measurement. A wide range of packaging formats, such as filled and sealed rigid, semi-rigid, and flexible packaging made of non-porous or porous materials, can be accommodated by Vacuum Decay technology. The FDA recognizes the standard Vacuum Decay leak test technique (ASTM F2338), which was created utilizing VeriPac instruments, as a consensus standard for container closure integrity testing (CCIT). The test method is recognized in the United States Pharmacopeia Chapter on CCI and listed in ISO 11607 (USP Chapter 1207).
How does Vacuum Decay Technology Work?
This test involves placing packages in an evacuation test chamber with an external vacuum source. The vacuum levels are continuously monitored in order to detect any deviations from a pre-determined targeted vacuum level. A defect in the package will allow air to escape into the test chamber. Packages with no defects, on the other hand, maintain a constant chamber vacuum level. Over the years, Vacuum Decay technology has proven to be one of the most practical and sensitive vacuum-based leak detection solutions.
Benefits of Vacuum Decay technology:
- Non-destructive, non-subjective, no sample preparation.
2. Capable of detecting defects down to 0.05 ccm.
3. Accurate, reliable, repeatable results.
4. Supports sustainable packaging and zero waste initiatives.
5. FDA recognized standard for package integrity testing.
6. ASTM test method F2338.
