The integrity of medical device packaging and pharmaceutical Container Closure Integrity (CCI) is vital to ensure patient safety. It is also now the essential part of the packaging process driven by guidelines detailed in United States Pharmacopeia (USP) General Chapter 1207 and multiple standards e.g. ISO 8871-5 Annex D for vials, ISO 11040-4 Annex H for prefilled glass syringes and part 6 for prefilled plastic syringes.
CCI by definition is the degree of package protection demanded by the product. Through a range of tests in our independent laboratories, we can help clients determine the integrity and strength of their sterile packaging.
Find out more about the importance of Container Closure Integrity Testing (CCIT) by downloading the article below, and see how Smithers can test to appropriate standards, ensuring the integrity and performance characteristics of your pre-filled syringes and other medical devices.
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