Description
THIS IS A COMMERICIAL NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. Title : PBF Water for Injection/Pure Steam/Distribution Systems Preventive Maintenance and Service Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR) INTRODUCTION The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya. Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development. The Pilot Bioproduction Facility (PBF) conducts research, development, production, and testing of vaccines and other biological products. Production is performed following and products are tested in compliance with current Good Manufacturing Practices (cGMP). Production is pilot-scale: 500 – 20,000 doses per finished lot of product. Products are released for use in Phase I - IIb clinical studies under Investigational New Drug applications (INDs). Vaccines being produced include, but are not limited to, those for prophylaxis against shigellosis, meningitis, malaria, and dengue fever. Conventional as well as recombinant and other genetically engineered vaccines are undergoing development and production at WRAIR. Other types of biological products (i.e. therapeutics) are capable of being produced as well under the right circumstances. A multiple effect distillation unit has been installed that vaporizes Reverse Osmosis/Deionized CAP II water. WFI is condensed from the PS output of up to three multiple effect distillation columns, which is then sent to a WFI storage tank. The contents of the storage tank is then circulated by the WFI distribution pumping system. This system includes a cooled circulation section of piping and a heated circulation section. Upon return to the storage tank, all water is reheated and injected back into the WFI tank. A fraction of the PS generated by the columns is not condensed and is instead sent to the pure steam distribution system. This system supplies autoclaves, fermenters, various other equipment, and manual use points within the PBF with pure steam for sterilization. SCOPE: The contractor will perform Quarterly, Bi Annual, Annual Maintenance, Five Year Overhaul, Preventive Maintenance, Emergency Maintenance, and Periodic/Volumetric Maintenance for the WFI/PS Systems. PERFORMANCE REQUIREMENTS: Specific Tasks / Requirements Quarterly: Review of Unit Operation (Includes Daily/Monthly checks) (Deliverable 2) • Perform Operational Safety checklist. • Check that the calibration status of all instruments are within the expected range of operation. Recalibrate instruments as necessary. • Check the distillate NORMAL / DUMP switch for operation. Observe the valves changing position. • Check the entire unit for leaks. • Blow down steam and condensate strainers. • Check and adjust blowdown flow. • Calibrate sanitary pump effluent discharge flow. Biannual (every six months) (Deliverable 3): • Perform TOC/conductivity analyzer calibration. • Replace sanitary pump seals, as needed. Annual: Replacement of Product Contact Elastomers (Includes Quarterly and Biannual Items) During Maintenance Shutdown (Deliverable 4) • Perform all routine quarterly PM items listed above (section 6.1.1). • Perform loop calibration of all sensors (TOC, conductivity, pressure, flow) and variable frequency drives. • Perform calibration of all gauges. • Replace filters, including 0.2 micron vent filters. • Chemically clean the units, tank, and distribution piping. • Replace feed water pump seals, if required. • Check steam traps and strainers, rebuild if required. • Check all electrical connections on the skids. • Check and descale cooling water side of condenser as required. Rigging is required. • Check and descale heat exchangers. Rigging is required. • Replace gaskets on each effect evaporator, as needed. • Replace condenser gaskets. • Perform hydrostatic test of condenser and all effects, if required. • Perform hydrostatic test of distribution loop heat exchangers. • Change PLC batteries. • Replace product contact piping gaskets, orifice gaskets, and valve diaphragms in the WFI/PS, Distribution System, and use points. • Upon completion of the annual maintenance work perform de-rouging, passivation, cleaning, rinsing, and re-sanitization of the WFI/PS tank, distribution piping systems, heat exchangers and field use points, as needed, to return the system to USP Chapter generation specifications. Five Year Overhaul: Replacement of all System Elastomers (Includes Annual Items) (Deliverable 5) • Perform all annual PM items. • Re-gasket the entire units (WFI/PS and Distribution Systems). • Rebuild all diaphragm valves. • Repack degasser, as necessary. The vendor shall supply all rigging, materials, supplies, and like-for-like piece/parts for the WFI/PS, and Distribution systems. Calibration per ISO requirements of all components of the system that include but are not limited to TOC, conductivity, time, pressure, temperature, and flow with recorded as-found and as-left values. An overall safety assessment report is to be included during annual maintenance. Emergency Services: The contractor shall provide up to two emergency service visits per contract year per system (WFI/PS/Distribution – 3 systems) with a response time not to exceed 24 hours including evaluation of failure mode, repair and/or replacement (or as soon as possible) for any piece or part of the WFI/PS systems. Technicians: All technicians performing work must be trained service technicians with training records. Training records must be stored and maintained by the service vendor and provided to the PBF upon request. All technicians must sign in and out of the PBF daily in the visitor logbook. All technicians will conform to lock out-tag out safety procedures common within industry for water, high temperature, weight bearing, and electrical systems. Technicians will be required to conform to PBF cleanroom gowning requirements, as needed, during any activity. Additional Services: The contractor shall provide additional emergency services as required with a response time not to exceed 24 hours. Compliance: The contractor shall abide by current Good Manufacturing Practice (GMP) and Good Documentation Practices (GDP). Management Reports and Plans Maintenance Reports (Deliverable 1): A written report for each service performed to repair/calibrate/maintain the WFI/PS systems shall be delivered within 30 days of each activity. All reports must follow good documentation practices, be legible, and include the full name and signature of personnel performing any work. Calibration, safety, or piece/part failure must be documented. Quality Control Plan (Deliverable 7). The contractor shall provide a draft Quality Control Plan (QCP) no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction. It is anticipated that a Request for Quote (RFQ) W81XWH20Q0007 will be electronically available on or about March 1, 2020. The RFQ may be accessed through beta.SAM.gov. All responsible sources may submit quote.