Sartorius™ Sterisart™ NF Sterility Testing System

Provides completely closed system sterility testing of pharmaceuticals, open containers, closed containers, pre-filled syringes, powders, and medical devices. Sartorius™ Sterisart™ NF Sterility Testing System is optimal for use with isolators.

Manufacturer: Sartorius™ 16476GSD

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Catalog No. 14-556-145

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    Capacity (English) 4 oz.
    Capacity (Metric) 0.12L
    Capacity 4 oz., 0.12L
    For Use With (Application) Sterility testing of pharmaceutical products, optimal for use in isolators
    For Use With (Equipment) Closed glass vials with septum
    Temperature Range (Metric) 50°C
    Temperature Range (English) 122°F
    Filtration Area 15.7cm
    Includes Sterisart NF gamma Septum with short dual-needle metal spike, sterile vented and with partitioned connector for sterile sampling from containers during incubation
    Pore Size 0.45μm
    Operating Pressure 3 bar at 20°C
    Sample Type SVPs
    Sample Composition Liquids
    Sampling Option Septum
    Sterilization Method Gamma irradiated

    International pharmacopoeias require the complete sterility of pharmaceutical products that are injected into the blood stream or that otherwise enter the body below the skin surface. As a manufacturer of such products, you are required to supply proof of sterility of the final product batch. Sterisart™ NF 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 the main risk of a secondary contamination and false positive results is eliminated. A peristaltic pump transfers the sample into the filtration units, and after rinsing, the filtration units are filled with media and used for incubation of the filters without any contact to the environment.

    • reliable Sartochem ™membrane
    • high retention of microbes
    • low adsorption
    • high mechanical stability
    • pre-installed color-coded tube clamps
    • easy-to-read graduated marks
    • user-friendly (several practical adapters available)
    • product-/lot number identification
    • gas-impermeable packaging for protection against sterilants

  • Description & Specifications

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