Sartorius® Sterisart system with septum for prefilled syringes

The Sterisart® NF system is a unique, complete disposable technology based on the membrane filtration method that allows sterility testing for pharmaceutical / medical devices. The user can choose his individual solution from more than 20 different units and decide which adapter/system fits best to the application. The Sterisart® Universal pump delivers the sample into the filtration units. After rinsing, the filtration units are filled with culture medium and used for incubation without any contact with the environment. After 14 days of incubation, a visible result is available (turbidity/no turbidity). The unique Sterisart® Septum version allows easy, aseptic sample collection during incubation, for dilution, for antibiotic (penicillinase) detection or inactivation. The Sterisart NF system is available with different types of adapters, e.g. for powders, medical devices (bags), prefilled syringes, open and closed systems. In addition, depending on the application, the customer can choose which sterilization process is preferred; both ethylene oxide (EO) gassed and gamma irradiated systems are available. Due to their packaging, the latter are specially designed for insertion into cleanrooms and isolators.In addition to the hardware and ready-to-use disposables, Sartorius offers a comprehensive service package with a complete sterility solution consisting of qualification documentation (IQ/OQ) and support, validation service and (preventive) maintenance service for the pump. Unique septum version for aseptic sampling High retention of microorganisms Low adsorption High mechanical stability Sharp metal needle for easy penetration Pre-installed, color-coded clamps Highly visible graduations User-friendly (various convenient adapter types available) Product/batch number identification Wide variety of adapters and more than 20 different gas-impermeable packaging for protection from sterilizing agents