Sterility testing in accordance with the International Pharmacopoeia

Friday, 11.09.2020. - 13:15

The International Pharmacopeia requires that each batch of products sold as sterile articles must be tested and certified for sterility prior to their sale and distribution. Therefore, sterility testing is part of the validation process as well as of routine release testing. For these dedicated tests, trained personnel, a regulated environment and high-quality materials that provide adequate and reliable sterility test data are absolutely essential. The comprehensive Sterisart® solution for sterility testing, which consists of hardware and single-use components as well as training and other related services, exactly meets all these requirements.

Pharmaceutical products are routinely manufactured under strict GMP guidelines. Despite these strict codes, as a fail-safe prior to batch release, all pharmaceutical products undergo stringent sterility testing to identify the potential presence of viable microorganisms. It is crucial that pathogenic microbes, such as bacteria, viruses and fungi, are detected in contaminated products before patients come in contact with them. There have been rare instances where compromised drugs have been released to the market with devastating consequences, for the patients and also the pharmaceutical companies.

Sterility testing in accordance with (USP <71>, EP 2.6.1)

Sterility tests are performed in accordance with the regulatory requirements defined by the International Pharmacopoeia (USP <71>, EP 2.6.1, JP 4:06). Sterility testing can be performed either by direct inoculation | transfer, or membrane filtration, which is the method of choice. Products are tested for sterility by direct inoculation only when the properties of the product do not permit membrane filtration. The membrane filtration approach typically relies on a closed filtration unit containing a membrane with a pore size not greater than 0.45 μm and that has reliably demonstrated the retention of microorganisms. Other components of the system include a suitable pressure supply (such as a peristaltic pump) that drives the sample across the membrane filter, an appropriate membrane rinsing solution, and growth | culture media. This closed setup is conventionally cleanroom compliant to eliminate any contamination risks and consequent false positives. Once sample filtration is complete, the closed system is incubated, typically for 14 days, and screened for turbidity as an indicator of microbial contamination.

Reliable membrane filtration method

As a reliable tool for sterility testing, we recommend our Sterisart® units - closed systems for sterility testing of pharmaceutical products based on membrane filtration. This closed system eliminates the need for physical manipulation of membrane filters and thus reduces the risk of secondary contamination and false positive results.

Ensure aseptic transfer of liquids with
Sterisart® Septum technology. Your
sample remains safely protected against contamination due to the septum’s sterile barrier, while also minimizing the risk of puncture injuries during sample injection due to the simple piercing mechanism.

Our Sterisart® peristaltic pump can be used in clean rooms, integrated into clean benches, or installed countersunk in the working surface of isolators. The pump is available as an upgraded version with display and user software.