Sterility Testing

Lab Division

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.

Sterisart® NF Sterisart® NF consumables are single-use units that constitute closed systems for performing sterility tests on open or closed containers, pre-filled syringes, powder, medical devices, etc.: A peristaltic pump attached by a needle or spike to these units transfers the sample in equal volumes into the filtration units, which are filled after rinsing with the respective culture medium and used for incubation of the filters, without any contact with the surrounding environment.

The Sterisart® Universal Pump The Sterisart® Universal Pump enables contamination-free, safe transfer of samples and media into the Sterisart® NF system. This peristaltic pump can be used in clean rooms, integrated into clean benches or installed countersunk in isolators. The Sterisart® Universal Pump is also available as an extended version with a display and user software. Thanks to its compact, low-profile design with a space-saving footprint, the pump takes up very little space on crowded benchtops – a great benefit.