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A row of transparent plastic syringes with grey caps, aligned on a white surface in a well-lit room, ready for lab testing and headspace analysis.

CCI Test Method Validation for Prefilled Syringes

Regulators are paying closer attention to the proper design of robust container closure integrity (CCI) methods and their validation.

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This case study describes the method that was developed and validated for detection of CCI defects at the plunger seal of a pre-filled syringe using an FMS Headspace Gas Analyzer and a CCI Test Vessel.