Sterisart® NF ? 16477 System for Liquids in Plastic Containers - 2 Pages

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Sterisart® NF ? 16477 System for Liquids in Plastic Containers

Catalog excerpts

Sterisart® NF – 16477 System for Liquids in Plastic Containers Specifications Pore size of the Sartochem® membrane filter 0.45µm, tested with Serratia marcescens 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. 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 c ­ onditions specified. The Sterisart® NF system 16477 has been s ­ pecifically designed for sterility testing of liquids in plastic containers. The unvented, non-coring needle with solid pointed tip and side opening minimizes clogging by particles when piercing the plastic container. The s ­ ample is pumped in equal volumes into the two Sterisart® containers and filtered. In the final step the culture media described by the pharmacopeias are pumped into these containers. The containers are subsequently incu­ ated for two weeks and then evaluated. b The enclosed venting needle guarantees venting of the container during sample transfer or the rinsing procedure as well as during media transfer. The Sterisart® NF type 16477 is 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 or 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 for liquids in Sterisart® NF gamma plastic containers (individually gamma sterilized, double-packed, optimal for use in isolators) Sterisart® Universal...

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