Sterility testing determines the absence/presence of viable microorganisms on product intended to be sterile, via current USP Immersion Sterility test methodology. Biological indicator sterility testing is performed to determine the absence/presence of viable spores on a biological indicator after it has been used during the sterilization run. These tests are important as they ensure that your product is sterile and safe to be used.
USP Sterility Test per USP 71
AAMI Sterility Test per ISO 11137 and 11737
Bateriostasis and Fungistasis Test
IPCD Biological Indicator Sterility Test per ISO 11138
EPCD Biological Indicator Sterility Test per ISO 11138
BI Enumeration Test
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Experience you can trust
Millstone Testing Services offers comprehensive regulatory testing services backed by more than 90 years of combined experience in the medical device and pharmaceutical sectors.