As pharmaceutical products leave the laboratory for distribution, they may be exposed to certain conditions that put their integrity at risk. Product quality deterioration and economic losses may be caused due to extreme temperatures or shocks during transportation. Pharmaceutical package inspection is vital to identify and control materials that may alter the protective capacities of packaging. Container Closure Integrity Testing of pharmaceuticals is performed with the purpose of guaranteeing the safety of the products during its distribution and storage lifecycle until delivery to the patient. CCIT helps in determining the integrity and stability of packaging or container until the point of delivery.
CCI testing using Vacuum decay technology
To guarantee integrity and consistency of packages, the ability to precisely detect leaks and defects is necessary. Although destructive Container Closure Integrity Testing (CCIT) methods like water bath, dye tests, peel and burst tests can detect leaks, they are time-consuming, unreliable and produce subjective test results. Additionally, they generate significant product loss and wastage. Over the years industry has seen an increasing demand for non-destructive package integrity testing methods. One such method is Vacuum Decay technology.
Vacuum Decay is a test method that has been proven over decades as the most practical and sensitive vacuum-based leak test method. It is a simple test method that challenges container integrity based on fundamental physical properties. Vacuum Decay technology creates reliable and accurate quantitative results with a pass or fail determination and has been established as a non-destructive deterministic alternative method to the blue dye test. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207)
How does Vacuum Decay Technology work?
Under this method, the leak testers are first connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a return on investment in under six months for many products.
Key Benefits of Vacuum Decay technology
- Non-destructive and non-invasive
- No sample preparation
- ASTM approved test method
- FDA Recognized Consensus Standard
- Allows for increased sampling
- Quantitative results
- Rapid test time
- Eliminates cost and waste of destructive testing
- Test results can be easily validated
- SPC laboratory testing or online applications
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