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| Successfully Navigating Opportunities With On-Body Delivery Systems – Common Questions And Answers | Container Closure Integrity (CCI) is essential to ensure sterile drug products remain safe, effective, and contamination-free throughout their shelf life. USP <1207> recommends evaluating package integrity from development through commercialization by defining the Maximum Allowable Leakage Limit (MALL) and selecting validated, application-specific test methods. The guidance favors quantitative deterministic methods over probabilistic approaches and emphasizes integrating CCI testing, seal quality assessment, stability studies, and lifecycle management to maintain product quality. |
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By Mark F. Witcher, Ph.D. | Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the medical device industry. | |
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| Cultural Audits: What Are They And Why Are They Essential? | Article | Pharma & MedTech Partner Division, B. Braun Medical Inc. | The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table. |
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| Fluoropolymer Tubing Guide | Infographic | IDEX Health & Science, LLC | Explore how temperature thresholds, purity needs, and optical clarity requirements drive fluoropolymer tubing selection for clinical analyzers, immunoassay platforms, and flow cytometry applications. |
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