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Sterisart® NF

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.:  16475--------GSD

Price:  $480.00

Availability:  In Stock *

*Detailed delivery date provided during check-out

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

Brochure

Sterisart® NF — Meet our family for sterility testing – reliable, economical, compatible
en 336.1 kB
宣传手册:微生物质量控制产品精简目录
zh 2.4 MB
Sterisart® BD Media and Fluids — One-Stop Shopping for Sterility Testing
en 1.5 MB
宣传手册:无菌检测产品
zh 4.2 MB
Sterisart® NF — Unsere Familie für den Sterilitätstest – sicher, wirtschaftlich, kompatibel
de 392.6 kB

User Manual

Sterisart® NF alpha 16466-ACD, 16467-ACD — Sterisart® NF gamma 16466-GBD, 16467-GBD
en 2.3 MB
Sterisart® NF gamma 16469-GBD
en 3.3 MB
Sterisart® NF gamma Septum 16466-GSD, 16467-GSD
en 2.2 MB
Sterisart® NF gamma Septum 16469-GSD
en 3.2 MB
Sterisart® NF gamma Septum16476
en 3.6 MB
Sterisart® NF alpha 16468-ACD, Sterisart® NF gamma 16468-GBD
en 2.7 MB
Sterisart® NF gamma 16470-GBD
en 1.8 MB
Sterisart® NF gamma 16477 GBD
en 2.2 MB
Sterisart® NF gamma16478-GBD
en 1.9 MB
Sterisart® NF gamma 16475-GBD
en 3.4 MB
Sterisart® NF gamma Septum 16475-GSD
en 3.0 MB
Sterisart® NF gamma 16476
en 3.3 MB

Product properties

  • Sample Form
    Easily Dissolved Powders
  • Design
    Two dual-needle spikes of different length, one is sterile vented, with septum
  • Sample Container Type
    Small Volume Glass Bottles <30 ml
  • Sampling Option
    Yes
  • Working Area
    Isolator
  • Filtration Area
    15.7 cm²
  • Pore Size
    0.45 µm
  • Sterility
    Sterile
  • Pack Size
    10
  • Package Type
    Individually Packed

Technical attributes

  • Animal Components
    No
  • Electrical / Battery item
    No
  • Sterilization Method
    Gamma irradiation
  • Fittings
    Dual Needle
  • Operating Pressure
    20 °C: 3 bar
  • Capacity of the Sampling Containers
    120 mL (graduation marks at 50, 75 and 100 mL)
  • Application
    Sterility Testing
  • Market
    Pharma/Biotech
  • Sample Type
    • Lyophylisate
    • Soluble powders
    • Liquid antibiotics
  • Permissible Operating Temperature
    < 50° C