Sterility tests are performed in accordance with the regulatory requirements defined by USP <71>, EP 2.6.1 or JP 4.06.
Sterisart® canisters are a closed system for sterility testing based on the membrane filtration method that mitigate the risk of secondary contamination. However, sample extraction is a prerequisite, when the growth media is rendered turbid by microbial growth, following the prescribed 14 days of incubation, to identify the microorganisms.
In this report, multiple sampling was performed through the Sterisart® canister septum – over 100 times – without compromising the sterility of the system.
Download the Application Note here.
