26-000983 revised Statement of Work (Services) - Trasis AllinOne rebuilding.docx

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Attached to
Rebuilding of TRASIS ALL-IN-ONE and Subsequent Maintenance Agreement
Solicitation number
PCA-NIMH-02360
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About this file

This is a Statement of Work (SOW) for the rebuilding and maintenance of a TRASIS ALL-IN-ONE radiochemical synthesis system at the National Institute of Mental Health (NIMH). The government acquired a used unit from the National Cancer Institute (Frederick, MD) that has not been serviced in three years and requires comprehensive restoration to safe and functional operating condition for use in hot cell 7 at NIMH's Bethesda facility.

The scope of work encompasses a complete rebuild and three-year preventive maintenance service package including: vacuum and pressure system restoration (lines, valves, check valves, regulators, pumps, and sensors); HPLC pump head rebuild with replacement of pistons, check valves, gaskets, seals, lines, filters, and bottles; inspection, testing, adjustment, and qualification of five syringe actuators and thirty rotary actuators; system installation with software and missing hardware components; pre-maintenance inspection and cleaning verification; calibration and qualification of vacuum, pressure, and radiation detectors; UV detector verification; HPLC system testing (leak, pressure, flow, priming, degassing); heater and safety thermoswitch verification; and two days of on-site training covering system operation, user maintenance, troubleshooting, and qualification results review. All replaced parts are covered under a one-year warranty. The contractor must provide travel costs, coordinate directly with government scientists in hot cell 7, and deliver installation documentation including IQ and OQ reports. The government is responsible for supplying required materials, chemicals, tubing, fittings, and utility gases. Electronic boards, computer hardware, software updates, external utilities, contamination, misuse, and radiation damage are excluded from coverage unless separately approved.

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Text version

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Rebuilding of TRASIS ALL-IN-ONE Statement of Need and Purpose:

The AllinOne must be restored to the functioning states by repairing/replacing/recalibrating many componenents (actuators and sensors) in order to be used for radiochemical synthesis in hot cell 7.

Background Information and Objective:

NIMH was awarded a used TRASIS AllInone by NCI (Frederick, MD) and the box has not been serviced by anyone for three years. A NIMH chemist, placed AllinOne in Von Gahlen hot cell 7 in room 351. He was able to operate rotary actuators and syringe pumps. However, according to the service engineers, Kaveh, there are many components in the system needs to be recalibarated and repaired to safely and effectively use the AllinOne. Miuse of the sensitive equipment results in severe damage to the valuable instrument.. There are HPLC injectors, UV detector, two Knauer HPLC pumps needs to be repaired and preventative maintenance service should be performed to operate the equipment properly.

The objective of this rebuilding service is to restore the AllinOne to the usable state where all actuators, and syringe pumps, and UV and radiation detector operate within manufacturer’s specification.

Period of Performance:

Not applicable

SCOPE OF WORK

General Requirements:

The rebuild includes the vacuum and pressure systems, including internal vacuum and pressure lines, valves, check valves, regulators, vacuum pump, vacuum sensor, pressure sensor, and related fittings.

For the HPLC system, the service includes the HPLC pump head rebuild, including pistons, check valves, gaskets/seals, HPLC lines, eluent lines, eluent filters, eluent bottles, HPLC waste lines, priming components, and waste bottles.

All 5 syringe actuators and 30 rotary actuators are inspected, tested, adjusted, and qualified. They are not fully rebuilt unless a specific defective component is found and approved for replacement.

Electronic cards/boards are not included for proactive replacement or rebuild unless a specific electronic fault is identified and separately approved.

Based on the current condition of the unit, we understand that several components required for proper installation are missing. These required installation-package components will be provided as part of this scope.

This quotation is for a 3-year preventive maintenance/rebuild service, installation, qualification, and training. It is not a separate extended service contract unless otherwise specified. However, all parts replaced during this service are covered under a one-year warranty.

Caution: Components that are inspected but not replaced are not covered as replacement parts. Electronic boards/cards, computer hardware, software/security updates, site utilities, external gas supply, contamination, misuse, radiation damage, and customer-maintained consumables are excluded unless specifically included in the quotation or separately approved.

Specific Requirements:

The quotation includes two days of training. The training will cover general system operation, routine user maintenance, basic troubleshooting, review of the serviced and installed components, and review of the qualification results.

The 3-year maintenance and installation service includes:

· System installation includes software and missing hardware installation.

· Providing the required missing installation-package components currently needed for installation

· Pre-maintenance inspection

· System cleaning verification

· Database backup

· CPU settings backup

· Statistics/aging data extraction

· CPU and power supply checks

· Fuses and batteries, as applicable

· Five Syringe actuator inspection and qualification

· Thirty Rotary actuator inspection, cleaning, and qualification

· Replacement of vacuum and pressure internal lines

· Replacement/service of check valves and related fittings

· Vacuum pump replacement/service

· Vacuum and pressure sensor calibration/qualification

· Regulator verification/calibration

· HPLC pump head rebuild kit installation, including pistons, check valves, gaskets, and seals

· Replacement of HPLC lines, eluent lines, filters, eluent bottles, waste lines, and waste bottles

· HPLC leak, pressure, flow, priming, and degassing tests

· Heater qualification, cooling test, and safety thermoswitch verification

· UV detector operational verification

· Radioactivity detector response verification, if activity is available

· Final maintenance, installation, and qualification report

LEVEL OF EFFORT:

Not Applicable

GOVERNMENT RESPONSIBILITIES

The government scientist should provide the required material for installation. For example, chemicals, tubing, fittings, and utility gas with adequate quality must be provided to the installing engineer in hot cell 7. The government scientist must learn how to operate the machine and how to write the programming scripts. Government scientists will lean also how to properly maintain the AllinOne.

DELIVERY OR DELIVERABLES

REPORTING REQUIREMENTS

The installation documents such and IQ and OQ shall be provided to the government scientists.

OTHER CONSIDERATIONS

Travel:

Must be included as part of the pricing.

Key Personnel:

Information System Security Plan:

N/A. The controlling PC will communicate to the hardware devices, mainly 30 actuators for valves and 5 syringe pumps, thermocouple sensors, pressure and vacuum sensors, many radiation sensors, HPLC UV detector, and and HPLC pumps (x2) and the PC will be isolated from the internet.

Data Rights:

N/A

Section 508—Electronic and Information Technology Standards:

Publications and Publicity:

Confidentiality of Information:

ATTACHMENTS

N/A

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

File details come from the government source that posted it. Updated .