Rapid sterility testing system (Milliflex Rapid 2.0)

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), requires the purchase of rapid microbial limit detection equipment capable of confirming bioburden contamination using membrane filtration with ATP detection. This system will enhance CDER’s current capabilities to test the microbial quality of purified bulk drug substances and final formulated drug products, and support research into the robustness of rapid/alternative microbial detection methods utilized by industry.

OPQR currently operates a second-generation Milliflex Oasis filtration pump (model MMSYSTMM2), which requires compatible filter funnels and microbial culture accessories. Therefore, the requested Milliflex Rapid System 2.0 (Millipore Sigma) must include an autospray station and detection tower that are fully compatible with the existing pump and filter membranes.