Container Closure Integrity Testing
When it comes to products like syringes, vials, and biologic containers, maintaining sterility is essential to patient safety. Container Closure Integrity Testing (CCIT) ensures your packaging stands as a reliable barrier against contaminants, microorganisms, and other threats. Through rigorous CCI testing, we validate that your container closure systems effectively protect product quality and safety.
What Is Container Closure Integrity Testing?
Ensuring the Sterility & Safety of Your Pharmaceuticals
Maintaining the sterility of pharmaceutical and biopharmaceutical products is paramount to ensuring their safety, efficacy, and potency. Container Closure Integrity Testing (CCIT) validates that your container closure systems act as an effective barrier against contamination, leakage, and other potential risks during storage, shipping, and handling. Through a combination of visual inspection, leak testing, and headspace analysis, CCIT ensures your packaging meets the highest standards of sterility, safety, and reliability.
At Purple Diamond, we offer both deterministic and probabilistic testing in our ISO-certified lab, ensuring comprehensive validation tailored to your needs.
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Vacuum Decay Method
ASTM F2338 is the Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method. This container closure integrity testing method involves drawing a vacuum on a package within a test chamber and monitoring the vacuum level for decay. It can be used to test nonporous flexible packages, rigid and semi-rigid packaging. Leaks down to 1µm can be detected in packs containing water based liquids, while leaks down to 50 µm can be detected in trays or cups that are non-lidded.
Electrical Conductivity & Capacitance (HVLD)
High-voltage leak detection is based upon the principle of electrical conductivity and resistance. A high voltage and high frequency charge is applied across the packaged product sample. The probe sends the current through the sample. The detection probe measures voltage received as a function of traveling through the container. This nondestructive method works for vials, syringes, and cartridges.
Blue Dye Ingress
During blue dye ingress testing, the packaging is submerged into a blue dye solution and subjected to various pressure cycles. If dye penetrates into the sample, this indicates vulnerability in the container closure integrity. This test method is classified as a “probabilistic” method.
Helium Leak Testing
ASTM F2391
ASTM F2391 is the Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas. This quantifiable test method uses a helium leak detector, also known as a Mass Spectrometer Leak Detector (MSLD), equipped with custom designed fixtures for the container or vial that is to be evaluated. The container closure system is calibrated against a NIST-traceable standard to set up parameters. Various types of containers such as vials, syringe systems, cartridges, and blister packs can be evaluated.
Headspace Gas Analysis (HGA)
This quantitative and nondestructive analysis of a container’s headspace provides a measure of the oxygen, carbon dioxide, water vapor, or internal pressure in rigid or non-rigid package headspace. This test method is used primarily with liquid filled paternal drug glass vials or syringes.
Bubble Emission
Bubble emission testing is a test method used to detect leaks in flexible and rigid packaging. By submerging the package in water, we can analyze whether any air or gas escapes through possible leaks, as indicated by the presence of bubbles. Leaks as small as .001in in diameter can be detected.
Discover Expert CCIT Solutions
Ensure sterility, safety, and compliance with container closure integrity testing from our expert team at Purple Diamond.
Why Purple Diamond?
Purple Diamond is your trusted partner in ensuring the sterility and safety of your pharmaceutical and biopharmaceutical products. Our ISO-certified laboratory combines state-of-the-art technology with unparalleled expertise to deliver comprehensive Container Closure Integrity Testing. Whether you’re focused on regulatory compliance or protecting patient safety, our team at Purple Diamond provides accurate, efficient, and thorough validation to help your products exceed industry standards.
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Whether you’re looking for a team of experts to engineer your new packaging product for optimal sustainability, or seeking a team who can ensure your products stay safe and secure during transport, Purple Diamond can help.
