USP 71
Sterility Test is carried out on products which are claimed to be sterile. Sterility test confirms that the product is free of viable microorganisms.
Accugen labs follow USP 71 (United States Pharsmacopeia,Chapter 71) methodology for Sterility testing. Test is conducted to ensure that the batch of the product is sterile or has been sterilized, meaning free of viable microorganisms. This crucial form of quality control is widely used in the medical device , pharmaceutical preparations, biological parenterals for human use, tissue materials and other materials that claim to be sterile or free of viable microorganisms.
Accugen labs provide Sterility testing which is compliant with United States Pharmacopeia (USP) , European pharmacopeia ( EP) and Japanese Pharmacopeia (JP) regulations.
One time Suitability test or bacteriostasis/ fungistasis test must be carried out on a formulation to validate the sterility test results. Suitability test is ordered prior to or at the time the sterility test is ordered.
Whether, the preservatives are added or not added in a formulation, the product’s other ingredients may have microbial growth inhibiting properties. Therefore, all products must undergo a one time suitability testing.
Sterility testing is conducted by different methods depending upon the nature of test material.
Sterility Testing by Membrane filtration method:
The test material is filtered thru membrane filters and then inoculated into two types of growth media supporting growth of aerobic, anaerobic bacteria and fungi.Samples are then incubated for 14 days.
Sterility Testing by Direct Inoculation :
The test material is directly inoculated into two types of growth media supporting growth of aerobic, anaerobic bacteria and fungi. Samples are then incubated for 14 days.
The test determines the sterility of only the sample(s) tested, therefore sample sizes must be evaluated carefully as per the USP guidelines to guarantee that they are representative of the entire batch of product.
Turn Around Time
USP 71 Sterility Test: 14-16 days
Testing takes 14 days to complete before results are recorded and the final report is sent out.
USP 71 Suitability Test:
Varies-More than or equal to 15 days can take depending upon the type of active agent used in a formulation.