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Sterisart® NF

Sterisart® NF

Sterisart® NF

Product catalog summary
Introduction
The document outlines the Sterisart® NF system, designed for sterility testing of pharmaceutical products. It emphasizes the importance of sterility for products injected into the bloodstream or entering the body below the skin surface, as required by international pharmacopoeias.

Sterisart® NF System Features
The Sterisart® NF system is equipped with a dual-needle metal spike for closed sample containers, minimizing contamination risk. Metal needles are durable and can be flamed for sterilization. The system is adaptable for open containers like ampoules and plastic bags, with special versions available for isolators.

System Design and Compatibility
The Sterisart® NF system maintains a closed design throughout the testing process, preventing secondary contamination. It is compatible with various pumps and requires specific adapters for different pump models. The system is suitable for routine or sporadic sterility testing in the pharmaceutical industry.

Membrane and Chemical Compatibility
The system uses Sartochem® regenerated cellulose membranes, known for low adsorption and chemical compatibility. The document provides a compatibility chart for various chemicals, indicating which components are compatible, limited, or not compatible.

Specifications
- Membrane filter pore size: 0.45 μm
- Filter area: 15.7 cm² per container
- Air filter pore size: 0.2 μm PTFE
- Sample container capacity: 120 ml
- Max operating pressure: 3 bar at 20°C
- Max operating temperature: 50°C
- Sterilization: Gamma irradiation

Ordering Information
The document lists various Sterisart® systems and accessories, including order numbers for different configurations and applications, such as systems for closed and open containers, pre-filled syringes, and containers with luer connectors.

Conclusion
The Sterisart® NF system offers a reliable and versatile solution for sterility testing, with features that enhance safety and compatibility across different testing environments.
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Catalog excerpts

Sterisart® NF-1

Sterility Testing Made Easy and Reliable

 Open the catalog to page 1
Sterisart® NF-2

Sterisart® NF – Versatile and Highly Compatible 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 the sterility of final product batch. Both gamma versions feature a gas-tight packaging that reliably retains gas, such as H2O2, used for routine sterilization inside isolators. This feature simplifies validation of Sterisart systems, helping prevent false negative results that might be caused...

 Open the catalog to page 2
Sterisart® NF-3

Chemical Compatibility of the Components Specifications Pore size of the membrane filter Filter area 15.7 cm2 in each Sterisart® container Pore size of the air filters 0.2 μm PTFE, validated acc. to HIMA for the retention of B. diminuta Sample container capacity Gamma irradiation Specifications subject to change without notice. (24-hour contact at 20°C) Sartochem® Tubing membrane Sterisart® containers Aqueous solutions Aliphatic hydrocarbons Salt solutions Weak acids Weak bases Aromatic hydrocarbons Halogenated hydrocarbons C = compatible, LC = limited compatibility, N = not compa

 Open the catalog to page 3
Sterisart® NF-4

Ordering Information Sterisart® NF sterility testing solutions Order number Sterisart system for liquids in closed, large volume containers such as bottles Sterisart system, with septum, for liquids in closed, large volume containers such as bottles Sterisart CA for liquids in closed, large volume containers such as bottles Sterisart system for liquids in open containers such as ampoules Sterisart system, with septum, for liquids in open containers such as ampoules Sterisart CA for liquids in open containers such as ampoules Sterisart system for liquids in closed, small volume containers such...

 Open the catalog to page 4

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.