Closed Filtration Pump for Sterility Testing

Minimum Technical Requirements: 

The Contractor shall provide a closed filtration pump for sterility testing that shall meet or exceed the following requirements:

•      The instrument shall consist of a peristaltic pump compatible with canister devices such as a canister that filter is comprised of mixed ester cellulose membrane-universal canister used for ampoules, IV bags, small volume parentals, powders in ampoules, large volume etc.; canisters with low absorption Durapore membrane and specific drain design for antibiotics and products that have antimicrobial agents; canisters that have low absorption Durapore membrane specific drain design and polyamide canister polymer for products dissolved in solvents or those that are difficult to filter for large volume paranterals, IV bags , ampoules etc..

•      The pump shall have a table integrated design to be compatible for an isolator horizontal

       worksurface (oval cutout).

•      A bottle holder mounted on the left side of the pump.to hold the products you are filtering

•      A drain tray mounted on the right side of the pump to hold the canisters being used.

•      A power cord/cable.

•      A flat seal.

•      The pump head must be capable of automatic opening and closing.

•      The pump housing should be made of stainless steel.

•      The pump housing and components to be resistant to vaporized hydrogen peroxide gas.

•      The peristaltic pump must have a speed of at least 235 rpm.

•      Shall be equipped with a keypad and rotary dial for selecting instrument settings.

•      Shall be equipped with a timer function capable of timing up to 900 minutes.

•      Shall be equipped with a pressure control system.

•      Shall be equipped with a color LCD user interface screen.

•      Shall have the ability to store at least 240 filtration protocols.

Trade and Service Specifications

1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.
2. FOB Point destination to include inside delivery.