These new sterility testing systems reduce filter manipulation and in turn eliminates the risk of secondary contamination and false positive results
Sartorius announces the launch of Sterisart NF (new family) for testing sterility of pharmaceutical products.
These new sterility testing systems reduce filter manipulation and in turn eliminates the risk of secondary contamination and false positive results.
Within the 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.
The international pharmacopoeias' preferred method of sterility testing is using membrane filters, as seen in the Sterisart NF range.
Any microorganisms present in a sample are concentrated on the Sartochem membrane filter surface in the sample containers, then nutrient media is added and the containers are incubated under the conditions specified.
The Sterisart NF units are easy to use with pre-installed tube clamps, clearly marked graduations, and product and lot number identification for easy traceability.
100% conformity to stringent international regulations (USP, EP, JP) is adhered to at all times, says Sartorius.
The Sterisart NF16466 is equipped with a dual-needled metal spike, which has been specially designed for closed sample containers.
The spike can be used for piercing stoppers and various types of other closures and can also be briefly flamed, thus minimising the risk of contamination.
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 slim needle enables samples to be drawn-up even from exceptionally small ampoules with narrow openings.
All Sterility NF family members can 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.