USP Sterility Testing
 In the U.S., legal requirements for USP sterility testing of pharmaceutical products and medical devices are set in the United States Pharmacopeia, USP Section <71>. These requirements make up regulators’ official first action method.
Microtest follows USP sterility testing guidelines to determine if a given sample lot is sterile or not sterile. Various other regulatory agencies — including the U.S. FDA, the ISO, and AAMI — recognize the USP method as, in effect, the highest standard.
One USP method tests for aerobic bacteria, another for anaerobic bacteria. Microtest can perform the appropriate test for new products, or for those incorporating a change in design or packaging. USP testing for sterility aims to provide reliable quality control data to support later sterilization validation testing such as bacteriostasis/fungistasis or membrane filtration tests.
Our experts work with your product development or quality assurance groups to develop a methodology that suits your product while meeting appropriate regulatory requirements.
Our equipment and facilities are also second to none. For instance, with products such as large catheters, full-immersion testing may demand a quantity of media beyond the capabilities of other laboratories. But Microtest can easily accommodate media containers of up to 2 liters for each sample — more, with regulatory approval.
Or if your medical product contains tubing with small internal diameters, Microtest can aseptically cut it into small sections for thorough testing. If your product is too thick or hard to section, we can arrange product flush testing.
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