Always on the Safe Side with Sterisart
21 September 2006
Sterility testing is a key step in the pharmaceutical release process. Sterisart® gives the user an economical and reliable tool for testing sterility.
Pharmaceutical products that are injected intravenously or enter the body by other subcutaneous routes must be sterile as required by the pertinent international pharmacopoeias.
Before releasing the product, the manufacturer must therefore supply proof that each batch of the final product is sterile. Membrane filtration is the preferred method for sterility testing as it concentrates microorganisms on the membrane surface. For this purpose, Sartorius developed Sterisart® NF, a completely closed system based on the membrane filtration method for reliable and convenient sterility testing.
Closed Unit
Sterisart® NF sterility test units eliminate the need for handling membrane filters, while maintaining a closed system throughout the entire sterility test. This reliably ensures that major risks for secondary contamination and false-positive results are excluded.
Virtually all pharmaceutical containers and product types can be tested thanks to the use of different adapters. Moreover, Sterisart® Gamma units are supplied in a new innovative packaging, which has been validated against all disinfectants commonly used in isolators (e.g. H2O2).
This makes handling the units in the isolator much easier and safer. An intelligent addition to the Sterisart® NF product line has been developed: a special peristaltic pump for isolators and clean benches (LAF hoods), which transports the sample to be tested through the various adapters into Sterisart® filtration containers. After filtration of the sample and rinsing, the filtration containers are filled with culture media, incubated according to the standard requirements and then visually inspected for sterility.
