Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
1. Membrane Filtration Sterility Testing
Membrane filtration sterility testing method is the method of choice for the filterable pharmaceutical products. According to the USP <71> in this sterility testing method products are filtered through 0.45 or 0.2-micron membrane filter. The filters are then rinsed with appropriate USP fluid to remove the inhibitors and then transferred into fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). Both media are incubated for 14 days and checked everyday for the presence of microbial growth. USP<71> Sterility testing suggest the use of fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM) because of their ability to promote the growth of anaerobic and aerobic microorganisms respectively.
2. Direct Transfer Sterility Testing
Direct Transfer sterility testing method is the method of choice for the medical devices and non-filterable pharmaceutical products, which includes solid dosage form, powders, ointments and creams. In this sterility testing method test articles are directly transferred into fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). Both media are incubated for 14 days and checked everyday for the presence of microbial growth.
3. Fluid Path Sterility Testing
This sterility testing method is method of choice for products that have hollow tubes, such as transfusion and infusion assemblies, where immersion is impractical and where the fluid pathway is labeled as sterile. In this sterility testing method products are flushed with fluid D and then eluate is membrane filtered and then transferred into fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). Both media are incubated for 14 days and checked everyday for the presence of microbial growth.
4. Membrane Filtration by Steritest
Steritest is the closed system membrane filtration sterility testing method for maximizing safety and convenience.
5. Rapid Sterility Testing
Gibraltar’s Milliflex® Rapid System for rapid sterility testing and rapid bioburden testing is based on the adenosine triphosphate (ATP) bioluminescence. By using the rapid sterility testing system results are obtained within 5 days.
Official Sterility Testing Sources used by Gibraltar Labs:
USP <71> Sterility Testing
As per AAMI/ANSI/ISO Guidelines.
According to the USP <71> Sterility testing the validation of the sterility testing also known as Bacteriostasis and Fungistasis Testing (B&F) must be conducted. This test is necessary to demonstrate that the product is free of inhibiting factors eliminating the occurrence of false negative results for sterility testing. Six simulated sterility testing samples are inoculated with less than 100 Colony Forming Units (CFU) of six specified microorganisms (3 in SCDM and 3 in FTM).The samples are observed for evidence of microbial growth daily and media turbidity must be observed within 5 days.
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Rapid Sterility Testing By: Derek Prince In June of 1936 the United States Pharmacopeia (USP) implemented the sterility test to better ensure the sterility of parenteral drug products. The test utilized one type of media and applied only to sterile liquids. Since then slight modifications have been made to include a broader range of product […]