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.

Catalog Number	Mfr. No.	Sample Composition	Includes	Sampling Option	Sterilization Method
14-555-828	Sartorius 16466ACD	Liquids	Sterisart NF alpha with long dual needle metal spike, sterile-vented	No Septum	EtO
14-555-830	Sartorius 16466GSD	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
14-555-829	Sartorius 16466GBD	Liquids	Sterisart NF gamma with long dual-needle metal spike, sterile vented	No Septum	Gamma irradiation
14-555-833	Sartorius 16467GBD	Liquids	Sterisart NF gamma with long needle and protective plate, sterile venting needle	No Septum	Gamma irradiation
14-555-832	Sartorius 16467ACD	Liquids	Sterisart NF alpha with long needle and protective plate, sterile venting needle	No Septum	EtO
14-555-841	Sartorius 16478GBD	Liquids	Sterisart NF gamma with female Luer Lock connector	No Septum	Gamma irradiated
14-555-835	Sartorius 16469GBD	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
14-555-836	Sartorius 16470GBD	Liquids	Sterisart NF gamma tubing system with two dual-needle metal spikes of different length	No Septum	Gamma irradiation
14-555-838	Sartorius 16475GBD	Easily dissolved powders	Sterisart NF gamma with two dual-needle metal spikes of different length, one is sterile-vented	No Septum	Gamma irradiation
14-555-839	Sartorius 16476GBD	Liquids	Sterisart NF gamma with short dual-needle metal spike, sterile-vented	No Septum	Gamma irradiation
14-556-140	Sartorius 16467GSD	Liquids	Long needle and protective plate, sterile venting needle and with partitioned connector for sterile sampling from Sterisart containers during incubation	Septum	Gamma irradiation
14-556-142	Sartorius 16468ACD	Liquids	Sterisart NF alpha with luer or Luer Lock connectors, long needle and sterile venting needle	Septum	Gamma irradiation
14-556-145	Sartorius 16476GSD	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
14-556-143	Sartorius 16469GSD	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

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