Request for Information regarding Commercially Available Steam Sterilizers The Army is seeking information regarding commercially available off-the-shelf (COTS) ruggedized steam sterilizers. The Army is researching information for a new gravity steam sterilizer system with water recovery feature that uses no more than three gall ons of water per day with a chamber size of not less than 2.7 cubic feet for use in the combat support hospital. Desired sterilizer system will be used in austere field environments, so it is essential that it be rugged, lightweight, easy to use and mainta in, and consume minimal power. The current sterilizer is no longer procurable. These items are necessary in the central materiel sterilization section of the combat support hospital to support sterilization of surgical instruments, linen packs, and other items as required for operation of the hospital. USAMMA is seeking pricing info to accompany the Request for Information (RFI). Essential Characteristics: (KPP=Key Performance Parameter) 1. When operated in accordance with the manufacturers instructions, the sterilizer shall demonstrate the ability to accomplish a complete kill according to AAMI standards for biological kill confirmation and the recommendations of the most recent US Pharm acopoeia. (KPP) A. Operate the sterilizer in accordance with the manufacturers instructions so that the test media in the chamber are exposed to a temperature of 270-272 degrees F for a period of 3 minutes and then exhaust the sterilizing chamber by means of a fast exha ust. B. Shall be able to remove the test media from the chamber in a manner that will preclude contamination. 2. Safety standards: A. Conform to appropriate sections of American Society of Mechanical Engineers (ASME) boiler and pressure code (KPP) B. Have FDA approval (KPP) C. Conform to electrical components requirements of the National Electrical Code (NEC) (KPP) D. Noise level not to exceed 85 decibels IAW Army Regulation 40-5 E. Incorporate safety features for protection of operating and service personnel F. Have time, temperature, and pressure indicators with warning lights and audible signals to alert operator of performance outside established parameters. (KPP) 3. Appropriate pressure gauges for the chamber and jacket shall be installed in the front of the sterilizer. Gauges shall be of a design and construction to render them breakage resistant under projected conditions of rough handling and field service. Crys tals (covers) may be of a suitable plastic. (KPP) 4. Shall have a safety valve meeting ASME standards. Safety valve shall be set for the design pressure (33 PSIG). (KPP) 5. Shall have an indicating thermometer installed that is convenient for observation by the operator. (KPP) 6. Steam generator shall have a water level gauge. (KPP) 7. All materials used for body, support structure, piping, and fittings shall be suitable non-corrosive metals or alloys. Wherever components of dissimilar materials are assembled or in contact, they shall be compatible. (KPP) 8. The sterilizer shall operate safely at steam pressures up to 33 PSIG and shall provide for operation at two temperature ranges at the option of the operator: 250 degrees F and 270 degrees F (to provide flash sterilization). (KPP) 9. The steam generator shall be of sufficient capacity for at least two complete sterilization cycles (including drying time) with one filling of water. The steam generator shall include a water recovery system that requires the addition of less than three gallons of water per day. (KPP) Please include the following items with your submission: 1) Consumable and associated components listings 2) Repair Parts listings 3) Manufacturer product information/instructions 4) 510K (FDA Approval) 5) Product pictures 6) Pricing Information This notice is a Request for Information only. The Army may at a future date evaluate the products via the information received as a result of this RFI in side-by-side testing for possible future contracts. Informational submissions should be made via e-mail or fax to Christopher Gloyd, Contract Specialist, at the following: Fax- (301) 619-2195 or E-Mail-
[email protected] No telephone calls will be accepted. Response due date and time is 1200 PM EST on 2 November 2006.