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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.
Supplier: Sartorius 16466GSD
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
| 4 oz. | |
| Sterility testing of pharmaceutical products, optimal for use in isolators | |
| 122°F | |
| 15.7 cm | |
| 0.45 μm | |
| LVPs | |
| Septum |
| 120 mL | |
| Closed glass bottles with septum | |
| 50°C | |
| Sterisart NF gamma with long dual-needle metal spike, sterile-vented and with partitioned connector for sterile sampling from Sterisart containers during incubation | |
| 3 bar at 20°C | |
| Liquids | |
| Gamma irradiation |