Sartorius, 16469--------GSD, Sterisart® system, with septum, 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.

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

Specifications
Applications:
Application: Sterility Testing
Application Area: Sterility testing
Laboratory Working Area: Isolator
Market: Pharma/Biotech

Connections (Physical):
Fittings: Adapter prefilled syringes

Dimensions:
Filter Diameter: ⌀ 50 mm
Filtration Area: 15.7 cm²

Features:
Sampling Option: Yes

General Specifications:
Capacity of the Sampling Containers: 120 mL (graduation marks at 50, 75 and 100 mL)
Culture Media: N/A
Design: Universal Luer adapter and long dual-needle spike, sterile vented, with septum
Membrane Color | Grid Color: white

Materials of Construction:
Filter Material: Regenerated Cellulose (RC)

Operating Conditions:
Operating Pressure: 20 °C: 3 bar

Physicochemical Information:
Pore Size: 0.45 µm
Pore Size Air Filter: 0.2 µm PTFE, validated acc. to HIMA for the retention of Brev. diminuta

Product Information:
Brand: Sterisart®
Container Type: Syringes
Pack Size: 10
Package Type: Individually Packed
Sample Type: Pre-filled syringes
Type: Consumables

Sterility/Purity:
Delivery Condition: Sterile
Sterilization Method: Gamma irradiation