Membrane filtration is the pharmacopeia method of choice for sterility testing. Viscous products, such as creams and ointments, can be difficult to filter and are normally diluted in a sterile solvent, such as Isopropyl Myristate (IPM). Testing such products may be problematic if specific testing procedures are not implemented and appropriate devices are not used. The ‟Green Base” Steritest® NEO device is the perfect choice for testing solvents, creams, ointments, and veterinary injectables due to its solvent-resistant and IPM-resistant nylon canister, Durapore® (PVDF) membrane, reinforced base structure and canister connection.
Figure 1.Isoproply myristate and Steritest® NEO canister.
The new Steritest® NEO device is upgraded with new improvements such as colored clamps, graduations for accurate volume measurement, optimized identification, and traceability with the new peel-off label. The test system offers an optimized and fully compliant testing process, when used with the Steritest® Symbio pump, specific accessories and high-quality culture media and rinsing fluids.
Figure 2.Schematic diagram of sterility testing using Steritest® NEO devices.
The following procedure is an example of a test method that will serve as a base during method development. It should be validated afterward following the instructions mentioned in pharmacopeia before use in routine.
According to pharmacopeias, method suitability must be demonstrated. Inoculate the last fluid rinse with not more than 100 CFU using microorganisms recommended in the pharmacopeias. Environmental isolates can also be tested. When the filtration is complete, add media (SCDB and FTM) to the canisters and incubate for the proper time and temperature, following pharmacopeia recommendations. Then growth is observed in the canisters, then the pharmacopeia acceptance criteria are met.
Note: In case of direct inoculation of microorganisms into IPM, the addition of 9% of NaCl peptone buffer ensures recovery rate above 50%.
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Our team of expert engineers will assist you in implementing method development and validation within your QC microbiology lab. Additionally, you will be provided with basic and advanced technical training on sterility testing, on-site or remotely.
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