What is CCIT
Container Closure Integrity Testing (CCIT) is a legal requirement to validate container closure systems. CCIT consists of a non-destructive mandatory container inspection system to ensure the packaging provides a barrier against potential contaminants.
“CCIT is necessary to ensure the sterility and stability of pharmaceutical and aseptic products”, says Gunther Coenen, co-founder of eyetec. “To ensure their safety and effectiveness, it’s imperative that these products remain free from microbial contamination commencing during the manufacturing process, and continuing across the distribution chain, incorporating the products shelf-life and all the way up to medical administration”.
In short, the purpose of CCIT is to discover and hence eliminate defects in containers and closure systems. Because the sterility cannot be guaranteed if the containers are thoroughly sealed against external interference.
The importance of CCIT
“The safety and effectiveness of sterile products depends on the integrity of the sealing system”, explains Coenen. “To avoid fatal consequences of micro-particles or microbial organisms entering a patient’s bloodstream, aseptic products and their packaging require strict testing procedures before they can be released on the market and administered to patients. Assuring the quality of the packaging is of prime interest for every manufacturer”. Given this importance, CCIT has also become a legally required stage of the production and validation process of pharmaceutical and aseptic products both in Europe (European Pharmacopoeia) and the United States (United States Pharmacopoeia - USP and the Food and Drug Administration - FDA).
Container Closure Integrity Testing is a method of leak detection using a non-destructive packaging inspection system to prevent possible contamination. Aseptic products are formulated in various forms ranging from liquids to gases, solids, and frozen formulations. The copious variety and ever-expanding formulations necessitate numerous types of containers such as bottles, tubes, blisters, ampoules, cartridges, and syringes in various materials such as glass, metal, and plastic. The multitude of containers, seals, and content types, call for unique testing methods. There are various methods that can be used for Container Closure Integrity Testing. eyetec uses High Voltage Leak Detection(HVLD), Vacuum Decay Leak Test and Pressure Decay Leak Test.
“Despite the variety of substances and indeed the differing containers required to protect the contents, they all have one thing in common, and that remains the effectiveness and robustness of the closure system. This fundament must be guaranteed under all circumstances to ensure the contents remain free from contamination”, says Coenen.
eyetec as trusted partner for CCIT
Due to the combined expertise in compliance and the technical aspects of pharmaceutical manufacturing built on more than twenty years’ experience in GMP manufacturing, eyetec is a trusted partner for healthcare industries. eyetec is acutely familiar with the exact tests that need to be performed and how to best advise and guide their customers to ensure compliance of parenteral pharmaceutical products.
eyetec is a leading international expert in the field of CCIT and visual inspection (VI). They have their own in-house team of vision engineers and are one of only three companies worldwide authorized to provide certified micrometer Leak Test Samples (LTS) to test CCIT equipment. In addition to consultancy and support services, eyetec also provides Leak Test Samples for companies that perform their own CCIT. eyetec produces LTS with different pinhole sizes depending on the types of primary packaging materials that the customer requires. Discover more about our Leak Test Samples here.