There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary. A broad issue for single-use filter users ...
At different stages of the drug lifecycle, the minimum provision for parenteral products is a safety barrier against potential contaminants. This protection is guaranteed by selected container closure ...
The revised USP Chapter Sterile Product Packaging-Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic ...
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