Traditionally, Dye Immersion and Microbial Immersion were the two leading methods for Container Closure Integrity Testing. Both methods are probabilistic and destructive test methods that require a significant number of sample units for validation.
In 2016, the United States Pharmacopeia (USP) released guidance stating that deterministic methods are preferred over probabilistic methods. Deterministic methods are non-destructive and offer reproducible results. There are several different deterministic methods like vacuum decay, airborne ultrasound, high voltage leak detection that can be used for optimal detection of product-package specific applications.
We want to help educate customers like you about Container Closure Integrity Testing (CCIT) and help you find the best-fit solution for your specific application. And with that said, we thought we would respond to some of the questions we get asked frequently about CCIT.
What exactly is Container Closure Integrity Testing and why is it important?
Container Closure Integrity Testing is a method of leak detection to inspect the container and closure for breaches or defects in order to prevent possible contamination. In simple words, Container Closure Integrity testing can be understood as a leak detection test. This type of testing is critical as any defect in the container can cause external particles or contaminants to enter the product, thereby reducing its shelf life.
Let’s use the pharmaceutical industry as an example. Products are expected to be free from microbial contamination and safe to use right from production throughout their shelf-life. The drug’s stability can be adversely affected through contamination in the form of oxygen, humidity or microbiological ingress. In order to prevent such risks, integrity tests with high sensitivity are required. Any defect in the packaging of drugs can have serious consequences, assuring the quality of the packaging is of prime interest for every manufacturer. CCIT will ensure product quality is maintained from the point of manufacture throughout its lifecycle until distribution to the patient.
What containers does this type of testing include?
Container closure systems include primary packaging components and secondary packaging components. Components such as a glass vial or syringe, which come into direct contact with the product, are primary packaging components. On the other hand, components that are crucial to ensure correct package assembly, such as aluminum caps, over stoppers etc. are the secondary packaging components.
What are the types of testing:
Container closure integrity testing can be performed in many different ways. Each method has its own pros and cons. A number of factors have to be considered while selecting appropriate testing methods. These factors include, but are not limited to; the reliability of the test method, material of the primary package and inline versus an offline testing requirement.
1. Probabilistic methods: Here, the testing methods are more traditional, and the accuracy of the result is subjective and uncertain. The probabilistic methods include the following:
• Microbial Challenge by Immersion
• Tracer Liquid Tests (e.g. Dye Ingress)
• Bubble Tests
• Tracer Gas (Sniffer Mode)
2. Deterministic methods: Such methods provide quantitative results with a higher level of accuracy. The chances of errors are also minimal. The deterministic methods include the following:
• Electrical Conductivity and Capacitance Test (HVLD)
• Laser-based Gas Headspace Analysis
• Mass Extraction
• Pressure Decay
• Tracer Gas (vacuum mode)
• Vacuum Decay
How do Deterministic Test Methods differ from Probabilistic leak test methods?
A probabilistic leak test method is the converse of a deterministic leak test method. Probabilistic tests rely on a series of sequential and/or simultaneous events, each associated with random outcomes described by probability distributions. Thus, the findings are associated with uncertainties that necessitate large sample sizes and rigorous test-condition controls to obtain meaningful results. Typically, sample size and test condition rigor are inversely related to leak size and in all cases, results are always qualitative. A qualitative measure of analysis for leak testing is a measurement approach based on a subjective evaluation of some quality, attribute, or characteristic of the test sample. Visual inspection is an example of a qualitative measure of analysis.
To ensure container closure integrity, PTI
has designed and developed seven different inspection sensory technology platforms. Each technology is based on the idea that there cannot be a test method without a validated and reliable test method. The technology solutions provided by PTI are centered on container closure integrity testing and give a deterministic measurement of package performance needed for critical applications.
If you are looking for more information about CCIT or the technology available from PTI – contact us
to speak to one of our experts.