The Food and Drug Administration (FDA) is seeking a “Brand Name or Equal” Millipore-Sigma Steritest Symbio Laminar Flow Hood (LFH) pump to be used in a laminar air flow hood for microbiological testing of pharmaceutical dosage forms. The pump must meet the minimum technical requirements specified in the solicitation, including compatibility with Steritest membrane filtration canister devices and a compact design for use in a 6-foot biosafety cabinet or laminar flow hood. The contract will be for a firm fixed price, and the delivery shall occur within 90 calendar days from the date of award.
• The pump must consist of a peristaltic pump compatible with Steritest membrane filtration canister devices.
• The pump shall have a compact design to be used in a 6-foot biosafety cabinet or a laminar flow hood.
• The pump shall be equipped with a pump head capable of automatic opening and closing during operation.
• The pump housing and components shall be resistant to vaporized hydrogen peroxide gas.
• The peristaltic pump shall have adjustable speed control with a maximum speed of at least 200 rpm.
• The pump shall be equipped with an integrated pressure monitoring system to detect abnormal filtration conditions.
• The pump shall include a pressure regulation or limiting function to protect membrane integrity.
• The pump shall be equipped with a user interface capable of configuring instrument settings and displaying operating status.
• The interface shall include a display screen capable of presenting operating parameters and alerts.
• The pump shall be equipped with a timer function.
• The pump shall have the ability to store at least 50 filtration protocols.
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