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 ...

All sterile drug manufacturer is required to check and demonstrate their manufacturing systems capable of maintaining container and closure barrier integrity throughout the product life cycle. As such ...

The US Food and Drug Administration released a final guidance on protocol for testing sterile products. Rockville, MD (Feb. 25)-The US Food and Drug Administration released a final guidance on a ...

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the ...

(MENAFN- PR Newswire) "Nikka Densok has a long and well-documented history in the development and use of high voltage electrical currents being used for drug container and package system integrity ...