Sterisart ® NF ?16468. Adapter for Medical Devices with Luer or Luer Lock Connector - 2 Pages

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Sterisart ® NF ?16468. Adapter for Medical Devices with Luer or Luer Lock Connector

Catalog excerpts

Sterisart® NF – 16468 Adapter for Medical Devices with Luer or Luer Lock Connector Specifications Pore size of the 0.45 µm, tested with Serratia marcescens Sartochem® membrane filter Sterility Testing Filter area 15.7 cm2 in each Sterisart® container Flow rate (for water) Pore size of the 0.2 µm PTFE, validated air filters to HIMA for the acc. retention of B. diminuta Sample container 120 ml (graduation marks capacity at 50, 75 and 100 ml) Max. operating pressure Max. operating temperature 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 last step nutrient media are added to these containers and the containers are incubated under the conditions specified. The Sterisart® NF system 16468 is equipped with a luer male connector onto which a detachable double female luer lock adapter is fitted. With this system it is possible to draw samples from collapsible medical devices | bags fitted with either luer | luer lock female or luer | luer lock male connectors. After the sample is removed from the collapsible bag, the double luer lock adapter is disconnected and replaced by the supplied 6 cm needle for drawing rinsing solution and culture media out of open containers. In the case of a closed container, it is additionally necessary to pierce the closure of the non-vented container with the supplied venting needle. The Sterisart® NF 16468 type is also available as 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 adapter to ensure the correct positioning of Sartorius NF units in the pumps of other manufacturers: 16412V (for older pumps) or 1ZG---0014 (for the latest pump versions). Sterilization (ethylene oxid gas) ETO or gamma irradiation

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Chemical compatibility of the components (24 hour contact at 20°C) Tubing Sartochem® membrane Sterisart® containers Aqueous solutions Aliphatic hydrocarbons Salt solutions Weak acids compatible compatible limited compatibility Weak bases limited compatible compatibility limited compatibility Aromatic hydrocarbons Esters compatible not compatible limited compatibility Halogenated hydrocarbons Ordering Information Name Order number Adapter for medical devices with luer or luer lock connectors (sterilized with ETO; single-packed) Adapter for medical devices with luer or luer lock connectors...

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