The level of quality required for medical device packaging is increasingly stringent and controls by sampling with methylene blue often prove insufficient.
Based on this observation, the company ASC Instrument has developed the ASC 7400F, a test machine that allows systematic testing of rigid medical device cases. The ASC 7400F technology allows precise measurement of the leakage level of these cases without compromising their integrity: all packaging tested to comply can be marketed. Leaking tested packages are recovered because their contents are not contaminated by methylene blue.
The ASC 7400F makes it possible to simultaneously test 5 cases and isolate the leaking one. A “process blocking” option prevents any accidental mixing of disputed cases with compliant cases: the leaking part is isolated and then released by an authorized person. The machine edits control reports in PDF format for archiving, and in Excel format for statistical data processing.
ASC Instrument offers an analysis methodology as well as support for quality managers or pharmacists in the implementation of this process.
Find out more: www.ascinstrument.com