Sterisart® NF ? 16476. System with Short Dual-Needle Metal Spike - 2 Pages

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Sterisart® NF ? 16476. System with Short Dual-Needle Metal Spike

Catalog excerpts

Sterisart® NF – 16476 System with Short Dual-Needle Metal Spike 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 0.2 µm PTFE, validated the air filters to HIMA for the acc. 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 bloodstream 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. Unlike plastic needles, metal needles do not snap off when tilted under pressure. This benefit together with the large protective plate on the spike not only facilitates to pierce stoppers. The plate construction also helps to prevent injury to fingers by ruling out breakage or slippage. The preferred method for sterility testing is the membrane filter method – any microorganism present is 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 type 16476 is available as special isolator version with the model suffix “gamma,“ which is indicated by the last letters of the order number: GBD. The Sterisart® NF system 16476 has been specifically designed for sterility testing of closed, unvented sample containers. The only 2.4 cm long double-metal needle considerably reduces the dead volume, which necessarily remains in the sample container during sample taking. The resulting sample is pumped in equal volumes into the two Sterisart® containers and filtered. In the last step the culture media described by the pharmacopeias are pumped into these containers. The containers are subsequently incubated for two weeks, then evaluated. 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). 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 System with short double-needle metal spike for closed (unvented) sample containers (gamma sterilized, double-packed, optimal for use in isolators) Sterisart® NF...

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