“Brand Name or Equal” Millipore-Sigma Steritest Symbio Laminar Flow Hood (LFH) pump

The U.S. Food and Drug Administration (FDA) is seeking information from potential vendors for a “Brand Name or Equal” Millipore-Sigma Steritest Symbio Laminar Flow Hood (LFH) pump. The pump will be used in a laminar air flow hood for sterility testing of pharmaceutical dosage forms. The FDA is looking for a pump that meets the minimum technical requirements specified in the document, which include compatibility with Steritest membrane filtration canister devices, a compact design, and adjustable speed control. • The pump must be a closed-filtration sterility pump. • The pump must be compatible with Millipore-Sigma Steritest Symbio ISL Pump. • The pump must have a compact design to be used in a 6-foot biosafety cabinet or a laminar flow hood. • The pump must be equipped with an integrated pressure monitoring system. • The pump must have a user interface capable of configuring instrument settings and displaying operating status. Interested vendors should submit a capability statement that includes company information, past performance information, and technical information demonstrating that the offered product meets the minimum technical requirements.