Sartorius Sterisart™ NF Sterility Testing System

Product Code. 10687683

Brand: Sartorius 16466ACD

Description

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.

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

Spezifikation

• Capacity (English): 4 oz.
• Capacity (Metric): 120 mL
• For Use With (Application): Sterility Testing
• For Use With (Equipment): Closed Glass Bottles with Septum
• Model: Sterisart Consumable
• Temperature (English): 122°F
• Temperature (Metric): 50°C
• Filtration Area: 15.7 cm
• Includes: Long dual-needle spike, sterile vented
• Pore Size: 0.45 μm
• Operating Pressure: 3 bar at 20°C
• Sample Type: LVPs
• Sample Composition: Liquids
• Sampling Option: No Septum
• Sterilization Method: EtO
• Sterility: Sterile