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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

  • Guaranteed sterile barrier for aseptic septum sampling
  • Gas-impermeable, color- and bar-coded packaging
  • Adapters for use of the Sterisart® NF System in all pumps

Popular Applications for the Sterisart® NF System

  • Sterility testing of pharmaceutical products and medical devices
  • Aseptic sampling

Item no.:  16467--------GBD

Price (USD):  $505.00

 

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.

Brochure

Sterisart® NF — Meet our family for sterility testing – reliable, economical, compatible
en 375.6 kB
Microbiological QC Solutions: Performance You Deserve, with the Compliance You Expect
en 4.7 MB
Sterisart Sterility Testing Playbook
en 3.8 MB

Datasheet

Sterisart ® Family — Consumables for Sterility Testing
en 1.3 MB

Flyer

Sterisart sterility testing - redefines standards.
en 702.2 kB
Sterisart Sterility Testing Flyer
en 358.1 kB

Validation Guide

Sterisart -Second Supplier Validation Guide
en 944.6 kB

Accessories Information

  • Adapter
    Dual Needle

Dimensions

  • Filtration Area
    15.7 cm²

General Specifications

  • Capacity of the Sampling Containers
    120 mL (graduation marks at 50, 75 and 100 mL)

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

  • Pack Size
    10
Sterisart® Universal Pump, without display

$12,660.00

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.

Sterisart® Universal Pump

$17,900.00

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® Syringe Filter, Polytetrafluorethylene (PTFE), Pore Size 0.2 µm, Ethylene Oxide, Female Luer Lock, Needle (38 × 1.7 mm), Pack Size 50

$270.00

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).