Many products used in the laboratory need to be certified as sterile. Numerous applications and lab techniques require that the labware used be free of contaminating microbes. Only products that receive a strict and controlled schedule of sterility testing can meet these high demands. In conjunction with or in place of the AAMI Methods, the United States Pharmacopeia is used. USP is considered an industry standard when it comes to sterility testing guidelines.
At MO BIO Laboratories we follow the most current version of the USP guidelines for our USP sterility tests. We offer both the Membrane Filtration Method and the Direct Transfer Method of sterility testing. If requested, we can work with you to pick the most appropriate method for your particular product and, based on batch size, how much of your product should be tested.
This method can be used, in some cases, for solid products but is most often used for liquid products. All steps of this procedure are performed aseptically in a Class 100 Laminar Flow Hood.
The product samples are agitated for at least 15 seconds then filtered through a filter membrane. This membrane is then transferred to a bottle of Tryptic Soy Broth media and a bottle of Fluid Thioglycollate media then incubated for 14 days. At day 3, day 7 and day 14 the filter and media are observed for growth. A passing USP sterility test shows no growth in either media over the entire incubation period.
This method is used primarily for solid products. All steps of this procedure are performed aseptically in a Class 100 Laminar Flow Hood.
The product samples are aseptically transferred directly into the appropriate amount of Tryptic Soy Broth media and Fluid Thioglycollate media. The samples and media are then incubated for 14 days. At day 3, day 7 and day 14 the filter and media are observed for growth. A passing USP sterility test shows no growth in either media over the entire incubation period.
Upon completion of each sterility test performed, a report and Certificate of Analysis are issued and mailed to the specified contact. This report outlines the items tested, the test method used, along with other specifics of the testing process.
To begin testing your products using the USP Sterility Test, a sample of the product must be received by our Services Department to evaluate how best to test your particular product for this type of testing.
To begin the testing process, Click Here.
You and your company decide upon a testing schedule that best fits the needs of your particular product. MO BIO Laboratories, Inc. can work with you to design a testing schedule that accomplishes this goal. Click here for more information.
Download an Excel file to submit your samples for testing by MO BIO.