Sartorius launches sterility testing systems
New Family (NF) range of sterility testing systems for
pharmaceuticals.
The Sterisart NF range includes testing systems for closed-sample vessels 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 blood stream 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 microorganisms present are concentrated on the membrane filter surface in the sample containers, then nutrient media is added to these containers, and the containers are incubated under the conditions specified.
The Sterisart NF16466 is equipped with a dual-needled metal spike 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. Also on the spike is a protective plate that makes it easy to pierce stoppers and helps prevent injury to fingers by ruling out breakage or slippage. The length of the dual-needle allows the same spike to be used for various types of closures, according to Sartorius.
The second adapter type, the Sterisart NF16467, is designed for use 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, according to the firm. Piercing of bags is minimised due to the needle length but also the needle can be flamed to reduce sample contamination.
Both the products 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.
They can also be used in existing sterility testing pumps with the use of adaptors although the Sterisart NF Universal pump is available for use in clean rooms, clean benches or isolators when installed into the working surface.
