RFI Preventive Maint Water Inject Pure Steam Dist System.pdf

REQUEST FOR INFORMATION (RFI)

Subject: Preventive Maintenance and Service for the water for Injection/Pure Steam Generation and Distribution Systems located at the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland 20910.

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY – THIS RFI IS ISSUED SOLELY FOR

INFORMATION AND PLANNING PURPOSES. THIS IS NOT A REQUEST FOR PROPOSALS

(RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A RFI. NEITHER

UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN

RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS

ANNOUNCEMENT. THIS NOTICE DOES NOT CONSTITUTE A COMMITMENT BY THE

UNITED STATES GOVERNMENT TO CONTRACT FOR ANY SUPPLY OR SERVICE

WHATSOEVER. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT

IS VOLUNTARY; THE UNITED STATES GOVERNMENT WILL NOT PAY FOR INFORMATION

REQUESTED NOR WILL IT COMPENSATE ANY RESPONDENT FOR ANY COST INCURRED IN

DEVELOPING INFORMATION PROVIDED TO THE UNITED STATES GOVERNMENT. NOT

RESPONDING TO THIS RFI DOES NOT PRECLUDE PARTICIPATION IN ANY FUTURE RFP OR

RFQ, IF ANY IS ISSUED.

1.0 DISCLAIMER: This RFI is issued solely for market research information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

2.0 SUBJECT: The PBF is conducting market research to assess the commercial availability of Preventive Maintenance and Service for the water for Injection/Pure Steam Generation and Distribution Systems.

3.0 DESCRIPTION: This is a non-personal services contract to provide water for injection/pure steam generation and distribution systems maintenance. This shall include providing all necessary personnel, equipment, supplies, transportation, tools, materials, supervision, and other items necessary to perform services as described in the Performance Work Statement (PWS) and associated contract documents, except for those items specified in Part 3 Government Property and Services. The contractor shall perform preventative maintenance (quarterly, semiannual, and annual), calibration, five-year overhaul, and emergency service, including all materials and supplies required to complete maintenance and repairs, for the continued operation of water for injection/pure steam generation and distribution systems (manufacturer: MECO) installed and used within the WRAIR, PBF to supply process water to autoclaves, fermenters, various other equipment, and manual use points as well as pure steam for sterilization in support of CGMP.

3.1 General Requirements: The contractor shall perform preventative maintenance (quarterly, semiannual, and annual), calibration, five-year overhaul, and emergency services. This includes all materials and supplies required to complete maintenance and repairs, for the continued operation of water for injection/pure steam generation and distribution systems (manufacturer: MECO) installed and used within the WRAIR, PBF to supply process water to autoclaves, fermenters, various other equipment, and manual use points as well as pure steam for sterilization in support of CGMP. The contractor shall keep the water and steam systems in complete working order at all times.

3.1.1 Procedural Requirements: All contractor technicians shall sign in and out of the PBF visitor logbook and conform to lockout/tagout safety procedures common within industry for water, high temperature, weight bearing, and electrical systems. Contractors shall be required to conform to PBF cleanroom gowning requirements, as needed, during any activity.

3.1.2 Documentation Requirements: All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with standard industry practices (e.g., FDA GMP GDP), ensuring electronically produced documents which reflect logical flow of material, tables of contents, indexes, and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

3.1.3 On-Site Repair Requirements:

a. The contractor shall respond within 24 hours (seven days a week).

b. The Government and the contractor will exchange hazard communication information before the commencement of any repair.

c. When required, the contractor will comply with the OSHA lockout/tagout standards while performing maintenance on Medical Devices/Medical Device Systems (MD/MDS).

d. The contractor shall communicate to the COR any major deficiencies or issues encountered during a service visit prior to leaving the facility.

e. Upon completion of services by the contractor, a service report shall be provided to the

COR. The service report shall provide detailed information regarding the cause of the MD/MDS malfunction and corrective action taken. It will include, at a minimum, the time required to complete the work, and a list of parts replaced with part numbers for each part prior to leaving the facility.

f. In the event all information is not available to the contractor when services are performed, the initial service report/invoice shall include all available information to close work order prior to leaving the facility. The contractor shall provide the balance of the required information no later than 15 days after services are completed.

g. The contractor's service representative (technician) will be factory trained and have a minimum of two years of experience working on the contracted MD/MDS.

h. The contractor must furnish all software updates/patches issued by the MD/MDS manufacturer.

i. The contractor shall have access to all necessary diagnostic software (if applicable). The contractor shall use only OEM new or OEM refurbished repair parts.

3.2 Routine Service: Tasks occurring on a scheduled basis consist of the following:

3.2.1 Maintenance Schedule: Develop a detailed annual maintenance schedule.

3.2.2 Scheduled Preventative Maintenance: A written report for each service performed to repair/calibrate/maintain the water for injection/pure steam generation and distribution systems shall be delivered within 15 days of completion of maintenance. All reports must follow GDP, be legible, and include the full name and signature of personnel performing any work. Additionally, any calibration, safety, or piece/part failure must be documented.

3.2.2.1 Quarterly Maintenance: The following preventative maintenance shall be performed every three months:

a. Review of unit operation logbooks.

b. Perform operational safety checklist.

c. Check that the calibration status of all instruments is within the expected range of operation. Recalibrate instruments as necessary.

d. Check the distillate dispense to tank or drain functionality, including interlocks.

e. Check the entire unit for leaks.

f. Blow down steam and condensate strainers.

g. Check and adjust blowdown flow.

h. Calibrate distribution (sanitary) pumps effluent discharge flow.

i. Check distillate flow sequence for normal operation.

3.2.2.2 Semiannual Maintenance: The following preventative maintenance shall be performed every six months:

a. Perform all routine quarterly items listed above (paragraph 3.2.2.1).

b. Perform Total Organic Carbon (TOC)/conductivity analyzer calibration.

c. Replace distribution (sanitary) pump seals, as needed.

3.2.2.3 Annual Maintenance: The following preventative maintenance shall be performed every 12 months:

a. Perform all routine quarterly and semiannual preventative maintenance activities listed above (paragraphs 3.2.2.1 and 3.2.2.2).

b. Replace product contact elastomers.

c. Perform loop calibration of all sensors (TOC, conductivity, pressure, flow) and variable frequency drives.

d. Perform calibration of all gauges.

e. Replace filters, including 0.2 micron vent filters.

f. Chemically clean the units, tank, and distribution piping.

g. Replace feed water pump seals, if required.

h. Check steam traps and strainers, rebuild if required.

i. Check all electrical connections on the skids.

j. Check and descale cooling water side of condenser as required. Rigging is required.

k. Check and descale heat exchangers. Rigging is required.

l. Replace gaskets on each effect evaporator, as needed.

m. Replace condenser gaskets.

n. Perform hydrostatic test of condenser and all effects, if required.

o. Perform hydrostatic test of distribution loop heat exchangers.

p. Change Programmable Logic Controller (PLC) batteries.

q. Replace product contact piping gaskets, orifice gaskets, and valve diaphragms in the water for injection/pure steam, distribution system, and use points.

r. Upon completion of the annual maintenance work perform de-rouging, passivation, cleaning, rinsing, and re-sanitization of the water for injection/pure steam tank, distribution piping systems, heat exchangers and field use points, as needed, to return the system to United States Pharmacopeia (USP) Chapter <1231> generation specifications.

3.2.3 Calibration: Perform calibration of all components of the system to include the TOC, conductivity, time, pressure, temperature, and flow with recorded as-found and as-left values consistent with International Organization for Standardization (ISO) 17025 requirements. For all contracts that require calibration of systems, the contractor shall complete DD Form 2163 (Verification/Certification Sticker) in accordance with the instructions provided in AR 40-61.

Additionally, a continuation sheet shall be attached to the DD Form 2163 indicating the manufacturer, model, SN, and date of calibration expiration of all items of Test, Measurement, and Diagnostic Equipment (TMDE) used to perform the calibration.

3.2.4 Five-Year Overhaul: This activity shall only occur in option period 4 (if exercised) and includes the following:

a. Perform all quarterly, semiannual, and annual preventative maintenance items.

b. Replace all system elastomers.

c. Re-gasket entire water for injection/pure steam distribution systems

d. Rebuild all valves.

e. Repack degasser, as necessary.

3.3 Non-routine Service: The contractor shall maintain the water for injection/pure steam generation and distribution systems in an operational state outside of scheduled preventative maintenance periods.

3.3.1. Emergency Services: The contractor shall provide emergency services 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 water for injection/pure steam generation and distribution systems. Due to the unpredictable nature of emergency service, emergency maintenance shall be invoiced as ODCs under a cost type CLIN to include all labor, materials, and supplies required to complete the necessary repairs.

3.3.2. 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.

3.3.3. 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.

3.3.4. 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.

3.1.8. Additional Services: The contractor shall provide additional emergency services as required with a response time not to exceed 24 hours.

3.1.9. Compliance: The contractor shall abide by current Good Manufacturing Practice (GMP) and Good Documentation Practices (GDP).

4.0 RESPONSE INSTRUCTIONS: Potential respondents shall describe in a Capability Statement their experience and how they would propose to successfully performing the services, assuming that all services provided by respondent would be accomplished in accordance with all applicable U.S. laws, regulations, policies, and procedures.

5.0 CONTACT INFORMATION: All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted to Ashley Atkins via email to ashley.n.atkins.civ@health.mil no later than 11:00 a.m. Eastern Time on Wednesday, 29 January 2025.