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

Sterisart® NF gamma Septum ? 16469. System with Adapter for Prefilled Syringes
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Sterisart® NF gamma Septum ? 16469. System with Adapter for Prefilled Syringes - 1

Sterisart® NF gamma Septum – 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. As a manufacturer of such products, you 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 microorganisms present are concentrated on the membrane filter surfaces in the sample containers, then nutrient media are added to these containers and the containers are incubated under the conditions specified. The Sterisart® NF system with the order number 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 | washing solution that is suctioned through a dual-needle metal spike. The liquid mixed in this manner is pumped in equal volumes into the two Sterisart® containers and filtered. Then the culture media described by the pharmacopeias are pumped into these containers, and the containers are subsequently incubated for two weeks, then evaluated. The new Sterisart® systems with a partitioned (i.e. septated) connector allow sterile sampling during incubation and guarantee a sterile barrier between the interior and exterior of the container during further incubation. The Sterisart® NF 16469 type is available as special isolator version with the model suffix “gamma Septum,“ which is indicated by the last letters of the order number: GSD. Sterisart® NF systems can also be used with other manufacturers’ pumps which have been specially designed for disposable closed sterility testing systems. This requires one of two adapters to ensure the correct seating of Sartorius NF units in the pumps of other manufacturers – adapter order number 16412V (for older pumps) or 1ZE---0014 (for the latest pump versions). However, you will not need these adapters if you are using Sterisart® Universal pumps 16419 and 16420. Recently designed by Sartorius Stedim Biotech, these versatile and flexible pumps offer considerable benefits, and are ideal for use in clean rooms and clean benches as well as in isolators when installed in the working surface. gamma irradiation

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

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 Order number Sterisart NF gamma System with adapter Septum prefilled syringes for (gamma sterilized, double-packed, optimal for use in isolators) Sterisart® Universal pump Basic version: Peristaltic...

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