C--Pharmacy Compounding AreaDesign, Construction Period Services andProject Cost Estimate

Furnish all design, construction period services and provide an estimate for the construction contract detailed below. This procurement is 100% set-aside for Small Emerging Business in accordance with the Small Business Demonstration Program (FAR 19.10). NAICS is 541330 with a size standard of $4.5 million in average annual receipts for the last three fiscal years. Procurement is also restricted to firms licensed in the state of Colorado. Firms desiring consideration should submit their SF330 no later than August 14, 2006. 1. CRITERIA: The VA Medical Center in Grand junction Colorado is interested in reconfiguring a portion of the pharmacy area on the first floor east wing to incorporate a pharmaceutical compounding , sterile preparation room that is in compliance with USP Chapter 797. The architect/engineer shall study the existing conditions of the building envelope and mechanical systems and recommend viable solutions that meet the needs of the pharmacy service and the requirements of the USP 797 criteria. USP <797> is considered to be an official minimum standard for pharmacy sterile compounding and it is therefore enforceable by the Food and Drug Administration (FDA), state boards of pharmacy and other regulatory agencies. As such USP <797> is an enforceable requirement that mandates procedures and processes for sterile drug compounding (mixing) of pharmaceuticals in a clean room environment. USP <797> specifies International Organization for Standardization (ISO) for acceptable clean room airborne particulate concentrations and assessment procedures. NIOSH has jurisdiction over the standards for drugs requiring separate preparation areas for personnel safety. 2. DEFINITIONS: 1. According to ISO, a clean room is defined as "a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g., temperature, humidity, and pressure, are controlled as necessary." Refer to USP<797> pharmaceutical compounding - sterile preparations, pharmacy design briefing document for this definition. 2. Refer to USP 797 pharmacy design briefing document. a copy is available from the facility engineering office for helpful information listed under pharmacy safety for ISO class 5, class 7 and class 8 clean rooms. 3. Air lock: A small room or space ("pass-through" chamber or window) between two rooms of different air pressure, with interlocked doors (one tightly closed at all times) to prevent loss of pressure in the higher pressure room. 3. DISCUSSION: USP 797 issued in January 2004 describes three risk levels defined by the complexity of the compounding process, namely Low, Medium and High risk level compounding, all of which require that work involving the sterile compounding shall take place under International Organization for Standardization (ISO) Class 5 conditions within a buffer area that should be ISO Class 7 with appropriate air conditioning and humidity controls in place in the buffer area environment. These standards are to be exemplified in every category. Class 5 environments require hundreds of air changes of HEPA filtered air, stringent gowning and masking requirements, Anteroom etc. The Class 5 environment is achievable in four ways: Option 1: Provide a Class 5 Clean room. Option 2: Provide a Class 5 critical area (laminar flow hood area) within a Class 7 Clean buffer room (deals with much lower standard of air particulates), in which all sterile compounding work takes place within a laminar airflow work station (LAFW). The LAFW is a biological safety cabinet with HEPA air supplied over the working surface. The anteroom or support area, which is outside the buffer area, should be ISO Class 8. Option 3: Perform all sterile compounding within Primary Air Flow Barriers (PAFBs). PAFBs are glove-box enclosures similar to totally enclosed biological safety cabinets. Option 4: Consider use of a portable clean room.