Keeping it in the family

Published: 11-May-2004


Sartorius has launched its Sterisart‚ NF (New Family) sterility testing systems. Within the Sartorius Sterisart‚ NF range there are sterility testing systems for closed sample containers, and for use with open containers, such as ampoules or collapsible plastic bags. International pharmacopoeias require the complete sterility of pharmaceutical products that are injected into the bloodstream or that otherwise enter the body below the skin surface. Manufacturers are required to supply proof of the sterility of final product batches. The preferred method of sterility testing is using membrane filters: any micro-organisms present are concentrated on the membrane filter surface in the sample containers, nutrient media is added to the containers and they are incubated under the conditions specified. The Sterisart NF16466 is equipped with a dual-needled metal spike, which has been specially designed for closed sample containers. The two needles allow the spike to be briefly flamed, thus minimising the risk of contamination. Unlike plastic needles, metal needles do not snap off when tilted under pressure. The second adapter type, the Sterisart NF16467, is used with open containers that do not require venting when samples for sterility testing are removed. The thickness and length of the individual needle enables samples to be drawn-up even from exceptionally small ampoules with narrow openings. Piercing of bags is minimised due to the needle length but the needle can be flamed to reduce sample contamination. Both Sterisart NF family members are available as a special isolator gamma version. A gastight bag retains gas, such as H2O2 used for routine sterilisation inside isolators. This feature simplifies validation of sterility test systems, helping to prevent false negative results that might be caused by H2O2 seeping into the inside of sterility test units. All Sterility‚ NF family members can be used in existing sterility testing pumps with the use of adaptors. However, the Sterisart‚ NF Universal pump is available for use in cleanrooms, clean benches or isolators when installed into the working surface. Tel: +44 (0)1372 737159 Or enter 111 on enquiry card

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