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.

Product Code	Brand	Sample Composition	Includes	Sampling Option	Sterilization Method
10687683	Sartorius 16466--------ACD	Liquids	Sterisart NF alpha with long dual needle metal spike, sterile-vented	No Septum	EtO
11700965	Sartorius 16466--------GSD	Liquids	Sterisart NF gamma with long dual-needle metal spike, sterile-vented and with partitioned connector for sterile sampling from Sterisart containers during incubation	Septum	Gamma irradiation
11790955	Sartorius 16466--------GBD	Liquids	Sterisart NF gamma with long dual-needle metal spike, sterile vented	No Septum	Gamma irradiation
11720965	Sartorius 16467--------GBD	Liquids	Sterisart NF gamma with long needle and protective plate, sterile venting needle	No Septum	Gamma irradiation
11740965	Sartorius 16468--------GBD	Liquids	Sterisart NF gamma with luer or Luer Lock connector, long needle and sterile venting needle	No Septum	Gamma irradiation
11730975	Sartorius 16478--------GBD	Liquids	Sterisart NF gamma with female Luer Lock connector	No Septum	Gamma irradiation
11750965	Sartorius 16469--------GBD	Liquids	Sterisart NF gamma with adapter for prefi lled syringes and dual-needle metal spike, Syringes with and without needlessterile-vented	No Septum	Gamma irradiation
11770965	Sartorius 16470--------GBD	Liquids	Sterisart NF gamma tubing system with two dual-needle metal spikes of different length	No Septum	Gamma irradiation
11720975	Sartorius 16477--------GBD	Liquids	Sterisart NF gamma with long needle (side opening, with solid pointed tip, non-coring), protective plate, sterile venting needle	No Septum	Gamma irradiation
11790965	Sartorius 16475--------GBD	Easily dissolved powders	Sterisart NF gamma with two dual-needle metal spikes of different length, one is sterile-vented	No Septum	Gamma irradiation
11710975	Sartorius 16476--------GBD	Liquids	Sterisart NF gamma with short dual-needle metal spike, sterile-vented	No Septum	Gamma irradiation
11730965	Sartorius 16467--------GSD	Liquids	Long needle and protective plate, sterile venting needle and with partitioned connector for sterile sampling from Sterisart containers during incubation	Septum	Gamma irradiation
15972530	Sartorius 16476--------GSD	Liquids	Sterisart NF gamma Septum with short dual-needle metal spike, sterile vented and with partitioned connector for sterile sampling from containers during incubation	Septum	Gamma irradiation
11760965	Sartorius 16469--------GSD	Liquids	Sterisart NF gamma Septum with adapter for prefi lled syringes and dualneedle metal spike, sterile-vented and with a partitioned connector for sterile sampling from Sterisart containers during incubation	Septum	Gamma irradiation
11700975	Sartorius 16475--------GSD	Easily dissolved powders	Sterisart NF gamma Septum with two dual-needle metal spikes of different length, one is sterile-vented, and with a partitioned connector for sterile sampling from Sterisart® containers during incubation	Septum	Gamma irradiation

Description

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

 

Specifications

• Capacity (English): 4 oz.
• Temperature (English): 122°F
• Filtration Area: 15.7 cm
• Operating Pressure: 3 bar at 20°C

• Capacity (Metric): 120 mL
• Temperature (Metric): 50°C
• Pore Size: 0.45 μm