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Tag: container closure GMP

Container Closure Integrity Evaluation During Stability Testing

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Container Closure Integrity Evaluation During Stability Testing Evaluating Container Closure Integrity in Stability Studies: Best Practices and Regulatory Expectations Container Closure Integrity (CCI) is a critical component of pharmaceutical stability testing, particularly for sterile and sensitive products. Without a robust container-closure system, the product is vulnerable to environmental contaminants such as moisture, oxygen, and microbes—undermining…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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