Sterisart® system, for pre-filled syringes
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.: 16469--------GBD
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
Laboratory Working AreaIsolator
Harmonized Tariff Schedule8421.29.0000
Electrical / Battery itemNo
FittingsAdapter prefilled syringes
Filtration Area15.7 cm²
Capacity of the Sampling Containers120 mL (graduation marks at 50, 75 and 100 mL)
DesignUniversal Luer adapter and long dual-needle spike, sterile vented
Operating Pressure20 °C: 3 bar
Pore Size0.45 µm
Pore Size Air Filter0.2 µm PTFE, validated acc. to HIMA for the retention of Brev. diminuta
Package TypeIndividually Packed
Sample TypePre-filled syringes
Sterilization MethodGamma irradiation
Sterisart® universal pump for sample and media transfer into the Sterisart® NF systems for sterility tests. The peristaltic pump can be used in clean rooms, integrated into clean benches, or installed countersunk in the working surface of isolators. Sterisart® universal pump is available as an upgraded version with display and user software. The sterility test system features a compact design with a space-saving footprint - a great benefit for most clean room benchtops and isolators.
Use the Sterisart® Universal Pump for sample and media transfer into Sterisart® NF systems for sterility tests. The peristaltic pump can be used in clean rooms, integrated into clean benches or installed in the working surface of isolators and RABS. The sterility test system features a compact design with a space-saving footprint - a great benefit for most clean room benchtops and isolators.
Top Features of the Sterisart® Universal Pump:
- Pioneering closed pump chassis design
- Integrated barcode scanner
- Effortlessly detachable components to facilitate easy cleaning
- Robust & durable: Rugged stainless-steel body that is compatible with all commonly used sterilants and fully VHP resistant
- Open-design: compatible with other filtration devices on the market
Popular Applications for the Sterisart® Universal Pump:
- Sterility testing of sterile pharmaceuticals and medical devices
- Sterility testing of cell culture media
Minisart® Air with chemically inert hydrophobic PTFE is suitable for venting as well as filtration of gases and oils with a pH of 3 - 12. Type 16596HNK with a pore size of 0.2 µm can be used for sterile filtration. It has an outlet with needle. Version HNK is individually packed and sterilized by ethylene oxide (EO).