text.skipToContent text.skipToNavigation

Sterisart® System with short Dual-Needle and Septum

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.

Order Number:  16476--------GSD

Availability:  On Request

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 — Unsere Familie für den Sterilitätstest – sicher, wirtschaftlich, kompatibel
de 392.6 kB
Sterisart® NF — Meet our family for sterility testing – reliable, economical, compatible
en 336.1 kB
Sterisart® BD Media and Fluids — One-Stop Shopping for Sterility Testing
en 1.5 MB

User Manual

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

Product properties

  • Filtration area
    15.7 cm²
  • Pore size
    0.45 µm
  • Working Area
    Isolator
  • Sampling Option
    Yes
  • Design
    Short dual-needle spike, sterile vented, with septum
  • Sample Container Type
    Small Volume Glass Bottles <30 ml
  • Sterility
    Sterile
  • Sample Form
    Liquids
  • Pack size
    10
  • Package Type
    Individually Packed

Technical attributes

  • Electrical / battery item
    false
  • Permissible operating temperature
    < 50° C
  • Operating Pressure
    20 °C=== 3 bar
  • Application
    Sterility Testing
  • Market
    Pharma/Biotech
  • Sample Type
    SVPs
  • Fittings
    Short dual-needle
  • Capacity of the sampling containers
    120 mL (graduation marks at 50, 75 and 100 mL)
  • Sterilization Method
    Gamma irradiation