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The Aseptic Core: Container-Closure Integrity | IVT

Container-closure integrity is a critical property of a pharmaceutical product. This attribute is especially important for sterile products. The US Food and Drug Administration guidance has categorized container-closure risks for common pharmaceutical products including degree of concern associated with route of administration (highest-low) and likelihood of packaging component-dosage form interaction (high-low). Sterile product container closure systems are described for most common sterile products including ampoules, sterile vials, and other systems. Multiple integrity test methods including...

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