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Study protocol for CCI (Container Closure Integrity) of vial 0.7ml High voltage discharge method

This study mainly refers to the requirements of USP <1207>, Technical Requirements for Consistency Evaluation of Quality and Efficacy of Generic Drugs for Chemical Injections, Technical Guidelines for Sealing Research of Chemical Injection Packaging System (Trial), and according to the nature of packaging materials and drugs themselves, an online high-voltage discharge leak detection method is proposed for sealing testing of tested samples. The equipment works for high voltage discharge leak detection made by Shandong HAWKEYE Machenical Technology Co., LTD.

 

The research report of high voltage discharge contains 3 sections: principle of detection method , equipment and sample information; method development of high voltage discharge leak detection ; verification to detection method .

 

 

The first section of the detection method principle, equipment and sample information: the method and equipment used were introduced in principle, and the samples and packaging involved in the research process were introduced.

section 2 and section 3 Test Method Development and validation: Methods are developed and validated prior to testing the product.

 

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