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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--------GBD

Price:  $455.00

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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).

Sterisart NF gamma, system for lyophilized or soluble powders in unvented vials

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

宣传手册:无菌检测产品
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宣传手册:微生物质量控制产品精简目录
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Applications

  • Application
    Sterility Testing
  • Laboratory Working Area
    Isolator
  • Market
    Pharma/Biotech

Compliance Information

  • Animal Components
    No
  • Electrical / Battery item
    No

Connections (Physical)

  • Fittings
    Dual Needle

Dimensions

  • Filtration Area
    15.7 cm²

Features

  • Sampling Option
    No

Operating Conditions

  • Operating Pressure
    20 °C: 3 bar
  • Permissible Operating Temperature
    < 50° C

Physicochemical Information

  • Pore Size
    0.45 µm
  • Sample Form
    Easily Dissolved Powders

Product Information

  • Pack Size
    10
  • Package Type
    Individually Packed
  • Sample Container Type
    Small Volume Glass Bottles <30 ml
  • Sample Type
    • Lyophylisate
    • Soluble powders
    • Liquid antibiotics

Specifications

  • Capacity of the Sampling Containers
    120 mL (graduation marks at 50, 75 and 100 mL)
  • Design
    Two dual-needle spikes of different length, one is sterile vented

Sterility

  • Delivery Condition
    Sterile

Usage Protocols

  • Sterilization Method
    Gamma irradiation
Sterisart® Universal Pump, without display
Sterisart® Universal Pump, without display

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.

Item no.:   16419

$11,335.00

Sterisart® Universal Pump, with display
Sterisart® Universal Pump, with display

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.

Item no.:   16420

$16,030.00

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

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).

Item no.:   16596--------HNK

$230.00