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.
New Sterisart® Family
The Sterisart® NF System is a completely closed system for the sterility testing of pharmaceutical products. It is based on the membrane filter method, however it eliminates the procedure of manipulating the filters. By this means the main risk of a secondary contamination and false positive results is eliminated. The Sterisart® NF System is a completely disposable technology based on the membrane filtration method, for the sterility testing of pharmaceutical products. By providing more than 20 different types of units, technicians can selectively choose which adapter or system best fits their application. The Sterisart® Universal Pump transfers the sample into the filtration units. After rinsing, the filtration units are then filled with culture media and used for incubation of the filters without any contact to the environment. After 14 days of incubation, a visible result is available (turbidity | no turbidity).The unique Sterisart® Septum version makes aseptic sampling easy, during or after incubation which is required for dilution or rapid detection, or for the supplement of additives for inactivation of antibiotics (penicillinase).
The Sterisart® NF System is available with different types of adapters i.e. for powders, medical devices (bags), pre-filled-syringes open and closed systems. Depending on the application, Ethyleneoxide (EO) and Gamma irradiated Systems are available. The latter have been specially developed to enable the transfer into clean rooms and Isolators thanks to their packaging.
Besides the hardware and the ready to use disposables, Sartorius offers a full service concept for the complete Sterility Solution, consisting of Qualification documents (IQ/OQ) and support, Validation Service and (preventive) maintenance service for the pump.
Sterisart® Universal Pump
The Sterisart® Universal Pump is available in two versions: as basic version 16419 and as an upgraded version 16420 with display and user software.The pump can be used in clean rooms, integrated into clean benches, or installed countersunk in the working surface of isolators. Its low, compact design has a space-saving footprint – a great benefit for most clean room benchtops and isolators.