Post by ten23 health
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š In sterile manufacturing, how do you prove that microbiological quality is ensured and sterility is maintained after the filling process is complete? The answer lies in Container Closure Integrity (CCI). As the pharmaceutical industry continues to implement the requirements of EU GMP Annex 1, container closure integrity (thankfully) has become an increasingly important element of contamination control strategies for sterile drug products. After all, even the most advanced aseptic manufacturing process can be compromised if the container closure system fails to maintain its protective barrier throughout storage, transportation, and use. Annex 1 places a strong emphasis on: š¹ contamination control strategies (CCS) š¹ lifecycle-based risk management š¹ science- and risk-based validation approaches š¹ and the verification of container closure integrity for sterile products CCI has to be approached holistically and conceptionally. From component selection, component fit analysis to a final product control strategy. Using sufficiently sensitive CCI methods with adequate negative and positive controls, sufficient sample size and preferably deterministic tests, as completed by probabilistic methods where required. At ten23 health, we support customers with an integrated approach to sterile drug product development and manufacturing, including: š¹ CCI strategy development š¹ container closure system qualification š¹ container closure integrity testing (CCIT) š¹ primary packaging selection and qualification š¹ sterile manufacturing and process validation Because in sterile manufacturing, product quality is not determined by a single process step. It is built through the interaction of formulation, packaging, manufacturing, testing, and quality systems. And ultimately, every element contributes to protecting what matters most: the patient. Find out more on our manufacturing services here: https://lnkd.in/euEvZivK #ten23health #Annex1 #ContainerClosureIntegrity #CCIT #SterileManufacturing #AsepticProcessing #Biologics #Pharma #DrugDevelopment #PatientSafety
