High-tech sterility test unit launched

International laboratory and process technology provider Sartorius AG has developed the Sterisart NF, a sterility testing product with a completely closed system based on the membrane filtration method.

Aimed at the pharmaceutical market, the test unit will enable pharma manufacturers to provide proof that each batch of the final drug product is sterile, as is required from intravenous and subcutaneous drugs by the pertinent international pharmacopoeias.

In sterility testing, reliability is key, and the closed system provided by the Sterisart unit ensures that major risks for secondary contamination and false-positive results are excluded, according to Sartorius. Different adaptors allow for the testing of a large range of pharmaceutical containers and product types.

Sterisart NF units can be order with a special peristaltic pump for isolators and clean benches (LAF hoods), that transports the sample to be tested through various adapters into Sterisart filtration containers.

After filtration and rinsing, the containers are filled with culture media and incubated, then visually inspected for sterility.