Sterisart® system for soluble lyophilisates in closed containers

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).

Sterisart NF gamma, system for lyophilized or soluble powders in unvented vials

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.

• Unique Septum Version for aspetic sampling
• High retention of microbes
• Low adsorption
• High mechanical stability
• Sharp Metal needle for easy penetration
• Pre-installed color-coded tube clamps
• Easy-to-read graduated marks
• User-friendly (several practical adapters available)
• Product-/lot number identification
• Huge variety of adapters and more than 20 different unit types
• Gas-impermeable packaging for protection against sterilants