Sterisart® NF ? 16469. System with Adapter for Prefilled Syringes - 2 Pages

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Sterisart® NF ? 16469. System with Adapter for Prefilled Syringes

Catalog excerpts

Sterisart® NF – 16469 System with Adapter for Prefilled Syringes 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) 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 last step nutrient media are added to these containers and the containers are incubated under the conditions specified. The Sterisart® NF system 16469 has been specifically designed for the sterility testing of liquids in prefilled syringes of various sizes (versions with and without needle). In addition, the system allows the exterior of needles attached to syringes to be sterility tested. The special retainer on the double tubing system is used as an adapter for attaching prefilled syringes. The contents of these syringes are drained into the Sterisart® system and simultaneously mixed with rinsing solution that is drawn through a dual-needle metal spike. The liquid mixed in this manner is pumped in equal volumes into the two S ­ terisart® containers and filtered. In the final step the culture media described by the pharmacopeias are pumped into these containers. The containers are subsequently incubated for two weeks, then evaluated. The Sterisart® NF 16469 types are available as special isolator versions. The version with the suffix “gamma Septum“(or GSD) has a partitioned (i.e. septated) connector which allows sterile sampling during incubation avoiding a risk of contamination. 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 s ­ terility testing systems. This requires an adapter to ensure the correct position 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 Sterisart® Order number NF gamma System with adapter for prefilled syringes (gamma sterilized, double-packed, optimal for use in isolators) Sterisart® NF gamma Septum System...

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