SpecificationsOrdering Info RequestPDFs


Sterility Testing Systems
Sterisart® NF

International pharmacopoeias require the complete sterility of pharmaceutical products that are injected into the blood stream or that otherwise enter the body below the skin surface. As a manufacturer of such products, you are required to supply proof of sterility of the final product batch.
Sterisart® NF is a completely closed system for the sterility testing of pharmaceutical products. It is based on the membrane filter method, however it eliminates the procedure of manipulating the filters. By this the main risk of a secondary contamination and false positive results is eliminated.
A peristaltic pump transfers the sample into the filtration units, and after rinsing, the filtration units are filled with media and used for incubation of the filters without any contact to the environment.

  • Reliable Sartochem® membrane :
    High retention of microbes
    Low adsorption
    High mechanical stability
  • Easy to use :
    Pre-installed color-coded tube clamps
    Easy-to-read graduated marks
    User-friendly, several practical adapters available
    Product-/lot number identification
  • Secure:
    Gas-impermeable packaging for protection against sterilants

Specifications

Pore size of the Sartochem® membrane filter

0.45 µm, tested with Serratia marcescens

Filtration area

15.7 cm² in each Sterisart® container

Flow rate (for water)

500 ml/min at 1 bar (approx. 15 psi)

Pore size of the air filters

0.2 µm PTFE, validated acc. to HIMA for the retention of Brev. diminuta

Sample container capacity

120 ml (graduation marks at 50, 75 and 100 ml)

Operating pressure

max. 3 bar (approx. 44 psi) at 20°C

Operating temperature

max. 50°C

Sterilization

ETO (ethylene oxide gas) or gamma irradiation

Ordering Info

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Disposable Sterisart® NF alpha , sterile, single packaged, sterilized by ETO, pack of 10

Order Number

Description

16466--------ACD

Sterisart® NF alpha, dual-needle metal spike for closed containers

16467--------ACD

Sterisart® NF alpha, 6 cm metal needle for open containers

16468--------ACD

Sterisart® NF alpha, system for medical devices with luer or luer lock connectors

Disposable Sterisart® NF gamma , sterile, double packaged, optimal for use in isolators, sterilized by gamma irradiation, pack of 10

Order Number

Description

16466--------GBD

Sterisart® NF gamma, dual-needle metal spike for closed containers

16467--------GBD

Sterisart® NF gamma, 6 cm metal needle for open containers

16468--------GBD

Sterisart® NF gamma, system for medical devices with luer or luer lock connectors

16469--------GBD

Sterisart® NF gamma, system with adapter for pre-filled syringes

16470--------GBD

Sterisart® NF gamma (single sterile packaged), system for difficult-to-dissolve powders in closed vials

16475--------GBD

Sterisart® NF gamma, system for Iyophilized or soluble powders in closed vials

16476--------GBD

Sterisart® NF gamma, system with short dual-needle metal spike for closed containers

16477--------GBD

Sterisart® NF gamma, system for liquids in closed plastic containers

16478--------GBD

Sterisart® NF gamma, system for liquids in containers and bags with Luer male outlets

16596--------HNK

Venting needle for ampoules, collapsible bags and vials, gamma sterilized (pack of 50)

Further units on request 16464ACD, 16464GBD