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.
Item no.: 16476--------GBD
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Sterisart NF gamma, system with short dual-needle metal spike for 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).
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
DesignShort dual-needle spike, sterile vented
Sample Container TypeSmall Volume Glass Bottles <30 ml
Filtration Area15.7 cm²
Pore Size0.45 µm
Package TypeIndividually Packed
Electrical / Battery itemNo
Sterilization MethodGamma irradiation
Operating Pressure20 °C: 3 bar
Capacity of the Sampling Containers120 mL (graduation marks at 50, 75 and 100 mL)
Permissible Operating Temperature< 50° C