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NEW SOW- pharmacy clean room suite continuation of current lease agreement The Salem VA Medical Center, Salem Virginia requires rental of a regulatory compliant clean room solution for the purposes of... NEW SOW- pharmacy clean room suite continuation of current lease agreement The Salem VA Medical Center, Salem Virginia requires rental of a regulatory compliant clean room solution for the purposes of compounding and storing hazardous and/or non-hazardous drugs. The requirement of this turn-key project solicitation is to maintain an adaptable clean room within existing pharmacy space with minimal service and construction disruption to existing operations and meeting all regulatory performance standards around sterile compounding standards. The clean room solution will allow for functionality and clinical capabilities from a compounding perspective. The clean room unit must be self-contained and self-supporting and includes walls, ceiling, flooring, lighting, and filtering equipment (FFU s). The clean room solution must meet all performance standards of USP 797 2008 edition, USP 800 compliance and be able to be easily and with minimum down-time, reconfigured to revised USP requirements when new publications occur. The clean room solution must contain a control panel to provide a real time continuous monitoring system with monitoring capabilites of temperature, humidity, air pressure, particle count, and must include appropriate audible alarms for when parameters go outside of USP 797 and 800 performance requirements and has the capabilities to be accessed/monitored remotely. The clean room solution must include automatic adjustments with regards to pressure relationships and temperature to comply with all regulatory requirements for this type of space.  The clean room solution provider must include a hands-free stainless steel sink in the garbing room. The clean room solution provider will engineer cleanroom to include balance of the airflow with regards to pressure relationships and temperature to comply with all regulatory requirements for this type of space by utilizing FFU s and HEPA s. Cost of rental will include delivery and installation and modification to maintain compliance with most current USP 797 and USP 800 requirements. Prior to installation, clean room provider will conduct an on-site evaluation and analysis and collaborate with the Medical Center s Facility Management Service and other GC s on utility requirements outside of clean room provider scope (mechanical, electrical, and plumbing) and configurations. Cost of rental will include quarterly service calls to evaluate performance of the room against USP standards, change any necessary parts, and any service required on room at the time of the service call. The clean room will include Interlocking doors between adjacent rooms ( ANTE ROOM to STERILE IV ROOM, ANTE ROOM to CHEMO IV ROOM, and preventing both the IV ROOM and CHEMO ROOM to be open to the ANTE ROOM simultaneously). All pass thru doors are to be interlocking, so that when one side is open the other door cannot be opened. II. Clean room provider must include the following specification and components: Wall Panels consisting of combination of glass and aluminum and easily cleanable surfaces Ceilings Low side wall air exhaust Medical Grade Sheet Vinyl Flooring with integral cove and base ( too meet USP standards an cleaning policies) Medical Grade Stainless Steel Sink, with integrated eyewash Stainless Steel Pass Through technology with interlocking mechanisms between positive pressure IV room and ante room Stainless Steel Vented Pass Through technology with interlocking mechanisms between negative pressure IV room and negative pressure storage Filter Fan units with provided HEPA filters for each, number and configuration will be provided in shop drawings. LED light fixtures and light switches for clean room Swing Automatic door operators with touch-less activation plates to comply with USP standards Real time Monitoring system with visual displays for pressure differential, temperature, humidity and particle count. Clean room installation team provides and coordinates all penetrations to clean room walls Clean room includes ongoing service/maintenance of entire program either via rental agreement or service agreement. Line of Demarcation in anteroom separating designated clean and dirty area. A garbing room prior to the ante room. Minimum 5 feet by 10 feet space. Which will be unclassified space. Continuous monitoring system maintained on latest software version and is updated as new versions are released or replaced if existing monitoring system is retired or no longer used by vendor. Continuous monitoring system which monitors temperature, humidity, pressure and particle counts for IV room, Chemo room, Ante room, Garbing room shall have easy exportation of data, preferably networked on Salem Clinical Wireless network. A minimum of 10 electrical outlets in the IV Room, 8 outlets in the Chemo rooms and 4 outlets in the ante room, with sufficient load capacity to power necessary equipment. A minimum of 4 network connection in the IV room, 4 in the chemo room and 4 in the ante room for computer network access. Ongoing maintenance contract to address all room service, maintenance and urgent service requests. This service contract will have regularly scheduled quarterly maintenance as well as urgent need assistance for room repair, additions or changes for USP 797 and USP 800 compliance, rebalancing of airflow and troubleshooting to maintain room operation.