Validation of Sterilizing Grade Filters - ASQ Long Island Section
Validation of Sterilizing Grade Filters - ASQ Long Island Section
Validation of Sterilizing Grade Filters - ASQ Long Island Section
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Bacterial Challenge TestMicrobiological challenge tests using one lot <strong>of</strong> low Bubble Point(close to manufacturer’s minimum specification) membranes shouldbe used. *Example:Minimum Bubble Point Value:Release criteria <strong>of</strong> filter vendor:Low BP Range:46 psi50 psi46 – 50.6 psi* At or near filter manufacturers minimum integrity test value (10%),1999 PDA / FDA Joint conference, PDA Newsletter December 199916
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