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Container Closure Integrity – Contain the Contamination

Container closure integrity failures can lead to significant risks to product quality. Find out PDA's take...

Container closure integrity failures can lead to significant risks to product quality.
Container closure integrity failures can lead to significant risks to product quality.

Industry faces many challenges when utilizing complex packaging systems and describing emerging technologies in the field of package integrity testing. Container closure integrity (CCI) failures can lead to significant risks to product quality. Failure of CCI is a critical risk, as a lack of package integrity can lead to product contamination. Contamination of a sterile product intended for parenteral administration can lead to dire consequences for the patient. Stability testing, method sensitivity and reliability, as well as suitability are some of the factors that need to be taken into account to reduce potential risk of contamination to products.

Best practices suggest that all processes be evaluated for risk to product quality attributes, and by extension, to the patient. The general goals of container closure integrity testing (CCIT) are to mitigate the risk through process validation and quality control. Testing for CCI is intended to provide evidence of the use of appropriately matched components and an adequate closing process. Once a product reaches commercial manufacturing, in-process control of critical production and processing steps are necessary.

Container closure integrity tests in conjunction with the control of the overall manufacturing process ensure a high level of CCI. Regardless of the choice of the integrity test method, the chosen method at the particular stage in the lifecycle of the product should be suitable for the intended use and able to reliably and consistently detect a critical leak that can potentially compromise product sterility. Details within USP <1207> serve as the principal guidance, focusing on the basic understanding of package integrity and some of the industry’s current best practices for CCIT.

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