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Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>). Container closure systems should maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life. Container

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UNITED STATES

AMRI

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Helium Leak Detection (HeLD)

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AMRI uses helium mass spectrometry to measure the package and seal integrity of nonporous packaging such as vials, syringes and cartridges.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Helium Leak Detection (HeLD)

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