Sartorius, 16467--------GSD, Sterisart® System for Liquids in Open Containers

The Sterisart® NF System is a completely closed system for the sterility testing of pharmaceutical products. It is based on the membrane filter method but eliminates the procedure of manipulating the filters. As a result, risk of secondary contamination (and false-positive results) is eliminated.
Top Features of the Sterisart® NF System

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 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).
Dual-Needle Metal Spike for easy and safe piercing
Our specially designed sampling needle, with its protective shield ensures safe and easy handling, even when working with cumbersome isolator gloves. Although primarily designed for open sample containers, the accessory venting needle ensures safe interaction with closed sample containers.
Safe, User-Friendly Operation
Intuitive handling has never been easier with the Sterisart® NF System’s color-coded tube clamps, preinstalled to make your work straightforward. Color- and bar-coding keeps items organized, while the gas-impermeable packaging feature means units are free from contaminants. Raised sterile venting with safety clearance prevents accidental clogging and minimizes secondary contamination. The outlet plugs are directly housed in a niche in the primary packaging and the extra-large, grip optimized filter plugs are pre-tethered to the vent filters for easy use with isolator gloves.
Aseptic sampling and supplementation
The septum port of the Sterisart® canisters have been purpose-built to aseptically draw samples for rapid sterility testing, intermediate testing, sub-culturing, and for supplementation with antibiotic inactivators. The port ensures a sterile barrier, while minimizing the risk of puncture injuries. Our meticulously controlled quality testing ensures the system is fully compliant with USP 71, Ph. Eur. 2.6.1 and JP 4.06.

Specifications
Accessories Information:
Adapter: Dual Needle

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

Dimensions:
Filter Diameter: N/A
Filtration Area: 15.7 cm²

Features:
Device/Instrument Compatibility: Sterisart® Universal Pump; Sterisart® Universal Pump, without display
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: Long needle, included sterile venting needle, 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: Open containers such as ampules or open bags
Pack Size: 10
Package Type: Individually Packed
Sample Type: LVPs; SVPs
Type: Consumables

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