Sterisart® NF ? 16478. Adapter for Medical Devices with Luer Lock Connector


Catalog excerpts

Sterisart® NF ? 16478. Adapter for Medical Devices with Luer Lock Connector - 1

Sterisart® NF – 16478 Adapter for Medical Devices with Luer Lock Connector Specifications Pore size of the Sartochem® membrane filter 0.45 µm, tested with Serratia marcescens Sterility Testing Filter area 15.7 cm2 in each Sterisart® container Flow rate (for water) ml/min at 1 bar 500 (approx. 15 psi) Pore size of the 0.2 µm PTFE, validated air filters to HIMA for acc. the retention of B. diminuta Sample container 120 ml capacity (graduation marks at 50, 75 and 100 ml) Max. operating pressure International pharmacopeias require the complete sterility of pharmaceutical products that are injected into the blood stream or that otherwise enter the body below the skin surface. Manufacturers of such products are required to supply proof of the sterility of the final product batch. The preferred method for sterility testing is the membrane filter method - any micro­ rganism present is o concentrated on the membrane filter surfaces in the sample containers. In the final step nutrient media are added to these containers and the containers are incubated under the conditions specified. The Sterisart® NF system 16478 is equipped with a dual-needle metal spike with a vent filter that is connected to the Sterisart® NF system via a single hose and a Y-distributor. A second shorter hose is attached to the other end of the Y-distributor fitted with a female luer lock connector. Using this connector, it is possible to draw samples from collapsible medical devices like bags fitted with luer lock male connectors. The dual-needle metal spike with vent filter is used to transfer rinsing solutions and | or nutrient media from closed vials. The Sterisart® NF type 16478 is available in a special isolator version with the model suffix “gamma“, which is indicated by the last letters of the order number: GBD. Ideally the systems are used in combination with the Sterisart® Universal pumps 16419 oder 16420. These can be used in clean rooms and clean benches or can be installed in isolators. Sterisart® NF systems can also be used with other manufacturers’ pumps which have been specially designed for disposable closed sterility testing systems. This requires an adapters to ensure the c ­ orrect position of Sartorius NF units in the pumps of other manufacturers: 16412V (for older pumps) or 1ZG---0014 (for the l ­atest pump versions). Gamma irradiation

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Sterisart® NF ? 16478. Adapter for Medical Devices with Luer Lock Connector - 2

Chemical compatibility of the components (24 hour contact at 20 °C) Sartochem® Tubing membrane Sterisart® container Aqueous solutions Aliphatic hydrocarbons Salt solutions Weak acids compatible limited compatibility Weak bases limited compatible compatibility limited compatibility Aromatic hydrocarbons not compatible limited compatibility Halogenated hydrocarbons Order number Ordering information Name Sterisart® Description NF gamma Adapter for medical devices with luer lock male connectors (individually gamma sterilized, double-packed, optimal for use in isolators) Sterisart® Universal...

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