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Article | April 30, 1998
Federal 'medicine' for drug errors may be hard to swallow
FDA to ease stability tests for drug packs
The Food & Drug Administration has relied on sterility testing by drug manufacturers to ensure that a drug product will be free of microbial contamination throughout the product's dating period. But the agency has long had concerns about the weaknesses of sterility testing. So now it is proposing to allow manufacturers to use container and closure integrity testing instead. The kinds of tests that are anticipated include physicial or chemical tests such as bubble tests pressure/vacuum decay trace gas permeation/leak tests dye penetration tests seal force or electrical conductivity and capacitance tests. In the microbiological category the tests could include microbial challenge or immersion tests. One of the shortcomings of sterility tests is they detect only viable microorganisms present at the time of the test. And even those microorganisms don't show up unless they are capable of growth in the specified culture media. Container and closure tests can detect contamination that occurred at any time during the product's life. They are less time consuming too. Sterility tests generally take a minimum of seven days.
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