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


Catalog excerpts

Sterisart® NF ? 16475. System for Lyophilized or Soluble Powders in Unvented Vials - 1

Sterisart® NF – 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. Manufacturers of such products are required to supply proof of the sterility of the final product batch. 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 filled into these containers. The containers are subsequently incubated for two weeks, then evaluated. 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 16475 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. The Sterisart® NF system 16475 has been s ­ pecifically 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 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). 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 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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Sterisart® NF ? 16475. System for Lyophilized or Soluble Powders in Unvented Vials - 2

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 Ordering information Name Sterisart® Description NF gamma System for lyophilized or soluble powders in unvented vials (gamma sterilized, double-packed, optimal for use in isolators) Order number Sterisart® NF gamma Septum System...

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