Sterisart® NF gamma Septum ? 16475. System for Lyophilized or Soluble Powders in Unvented Vials - 2 Pages

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Sterisart® NF gamma Septum ? 16475. System for Lyophilized or Soluble Powders in Unvented Vials

Catalog excerpts

Sterisart® NF gamma Septum – 16475 System for Lyophilized or Soluble Powders in Unvented Vials 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 the 0.2 µm PTFE, validated air filters to HIMA for acc. the retention of B. diminuta. Sample container 120 ml capacity (graduation marks at 50, 75 and 100 ml) Max. operating pressure System for lyophilized or soluble powders in unvented vials (e.g., antibiotics) 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 order number 16475 has been specifically designed for sterility testing easy-to-dissolve powders (e.g., lyophilized antibiotics in powder form). The dual-needle metal spike with a vent filter is used to remove dilution solution from closed vials, and is connected along with a short metal dual-needle spike to a single tube. The shorter dual-needle metal spike, which is additionally connected by the double tubing system to the Sterisart® containers, is used to fill dilution solution and, in conjunction with this, to dissolve the powder in the sample container (e.g., lyophilized antibiotic powder). The dissolved powder is pumped through this double-needle spike into the two Sterisart® containers and filtered. 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 16475 type is available as a 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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Chemical Compatibility of the Components (24-hour contact at 20°C) Sartochem® Tubing membrane Sterisart® container Aqueous solutions Aliphatic hydrocarbons Salt solutions Weak acids Compatible Limited compatibility Weak bases Limited Compatible compatibility Limited compatibility Aromatic hydrocarbons Not compatible Limited compatibility Halogenated hydrocarbons Order number NF gamma System for lyophilized or soluble Septum powders in unvented vials (gamma sterilized, double-packed, optimal for use in isolators) Sterisart® Universal pump Basic version: Peristaltic pump for use with sample...

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