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.	Sterilization Method	Sample Composition	Includes	Sampling Option
14-555-828	Sartorius 16466ACD	EtO	Liquids	Long dual-needle spike, sterile vented	No Septum
14-555-830	Sartorius 16466GSD	Gamma Irradiation	Liquids	Long dual-needle spike, sterile vented, septum	Septum
14-555-829	Sartorius 16466GBD	Gamma Irradiation	Liquids	Long dual-needle spike, sterile vented	No Septum
14-555-833	Sartorius 16467GBD	Gamma Irradiation	Liquids	Long needle, by-packed sterile venting needle	No Septum
14-555-832	Sartorius 16467ACD	EtO	Liquids	Long needle, by-packed sterile venting needle	No Septum
14-555-835	Sartorius 16469GBD	Gamma Irradiation	Liquids	Universal Luer adapter, long dual-needle spike, sterile vented	No Septum
14-555-836	Sartorius 16470GBD	Gamma Irradiation	Liquids	Tubing system w/ two dual-needle metal spikes of different length	No Septum
14-555-838	Sartorius 16475GBD	Gamma Irradiation	Easily Dissolved Powders	Two dual-needle spikes of different length, sterile vented	No Septum
14-556-140	Sartorius 16467GSD	Gamma Irradiation	Liquids	Long needle, sterile venting needle, septum	Septum
14-556-142	Sartorius 16468ACD	Gamma Irradiation	Liquids	Female luer lock connector	Septum
14-556-145	Sartorius 16476GSD	Gamma Irradiation	Liquids	Short dual-needle spike, sterile vented, with septum	Septum
14-556-143	Sartorius 16469GSD	Gamma Irradiation	Liquids	Universal Luer adapter, long dual-needle spike, sterile vented, septum	Septum

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.
• For Use With (Application): Sterility Testing
• Temperature (English): 122°F
• Filtration Area: 15.7 cm
• Operating Pressure: 3 bar at 20°C

• Capacity (Metric): 120 mL
• Model: Sterisart Consumable
• Temperature (Metric): 50°C
• Pore Size: 0.45 μm
• Sterility: Sterile