20-002962 - Hot Cells PD Pike Revised 3-26-2020.pdf

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

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: The NIMH/PET Radiopharmaceutical Sciences Section (PRSS), since its inception in 2002, has had six hot-cells for experimental radiochemistry and radiotracer production for animal experiments in support of its main remit – the development of novel radiotracers with utility for the study of neuropsychiatric disorders and related drug development. These hot-cells are now replete with automated apparatus for performing certain types of radiochemistry (e.g., 11C-methylation, 18F-radiofluorination) and for the use of this radiochemistry to produce candidate radiotracers for evaluation in animals (mouse, rat, monkey) with positron emission tomography (PET) experiments. Over the last two decades, important methodological advances have been made in radiochemistry with cyclotron-produced short-lived carbon- 11 (t1/2 = 20 min) and fluorine-18 (t1/2 = 110 min) which expand the chemical space for developing PET radiotracers. From our own laboratory, major advances include methods for synthesizing and applying [11C]fluoroform, [18F]fluoroform, and [11C]fluorophosgene. Extra hot-cell space is needed to exploit these advances for producing new candidate PET radiotracers for evaluation with PET in animals and to augment possibilities for further methodological advances in radiochemistry.

2. Background Information and Objective: All PET radioligands developed by PRSS within MIB are first evaluated in animals before being studied in humans. The new radioligands benefit all who use them, including intramural collaborators as well as numerous extramural and international PET centers. In addition, we use monkey PET imaging to help extramural sites develop new radioligands. As an example, we are currently helping an extramural investigator at Harvard University develop a PET radioligand for orexin receptors. The collaborator performs the medicinal chemistry and we perform radiochemistry and PET imaging to evaluate the candidates. As another example, we have recently started to collaborate with Yale University, which has recently become a NIMH-funded Center for PET radioligand development. We are helping them develop new and improved radioligands for the NMDA receptor.

In order to expand our capacity for PET radiochemistry development and for the synthesis of new candidate PET radiolignds, we propose to purchase an extra pair of hot-cells of very similar custom design to those that have served us exceedingly well over the last 18 years. Our plan is to reconfigure the present laboratory suite on the B3 level of Building 10 adjacent to the cyclotron facility to house the two new hot-cells. This construction project has recently been set in motion. The acquisition of the new hot-cells has been supported by successive BSC reviews of Dr. Pike, including the latest in February 2019.

3. Generic Name of Product: Radiochemistry Hot-cells

4. Purchase Description: The purchase will be a pair of custom-made adjoined research hot-cells.

5. Salient characteristics: The main purpose of these hot-cells will be to provide radiation protection to chemists who will be controlling automated radiosynthesis apparatus conducted within the hot-cells. The following requirements are to support experimental radiochemistry within the hot-cells. The following requirements are to support experimental radiochemistry within the hot-cells.

1) Allow rear and front entry with motorized vertically moving 75mm thick lead doors, one at front and one at rear of each hot -cell

2) Front door to be fitted with lead glass window (350 x 300 mm; W x H)

3) Side door opening in one hot-cell (206 x 246 mm; W x H)

4) 2 Glove ports in each front door

5) Allow measurement of radioactivity with a 75 mm lead-shielded commercial ionization chamber with entry into the floor of the hot-cell

6) Allow shelving etc. to be installed on bread-boards mounted at internal back and sides of each hot-cell

7) Include within each hot-cell an internal ceiling-mounted filter for exhaust gas, for safe removal of volatile radioactive material

8) Include penetrations to be specified for entry/transfer of radioactive material, electrical, and power cables

9) Be designed for entry of five laboratory gases, with external switch control on the face of the hot-cell

10) Be equipped to support external shelves above the door of each hot-cell

11) Have open space under each hot-cell for housing equipment associated with the radiochemistry to be conducted within the hot-cell

12) Be equipped with power outlets on the roof of the hot-cell, within the hot-cell and under the hot cell for powering radiosynthesis equipment

13) each hot-cell to have internal LED lighting

14) The external dimensions of each hot-cell are not to exceed 1552 x 1214 x 2650 mm

(W x D x H), and internal dimensions 1200 x 820 x 744 (W x D x H)

For the Hot-cells install:

1) The installation contractor will have a Certified Industrial Hygienist (CIH) on staff and draft the Accident Prevention Plan (APP) compliant to the Army Corps of Engineers EM385-1-1, Indoor Air Quality (IAQ) Plan, and material handling practices to verify implementation and compliance to NIH, OSHA, and EPA requirements throughout the project to prevent government property from becoming contaminated and exposure to NIH occupants.

2) The installation contractor will coordinate activities with the NIH 3rd Party Oversight Contractor for verification of compliance to plans, NIH requirements, and

Federal/State/Local regulations and standards. Funds for NIH 3rd Party Oversight, through DOHS, will be provided by the IC.

3) Contamination of government property will require prompt remediation in accordance with the NIH “Lead COC Chart” attached and coordinated through NIH DOHS and

NIH DEP.

4) The contractor will be strictly responsible for complying with the 29 CFR 1910.1025 and 29 CFR 1926.62.

5) The installation contractor will complete and submit the signed AFFIRMATION OF DELIVERABLES form and its deliverables, to the project officer and DOHS, a minimum of two weeks prior to commencing onsite activities for review and comments.

a) Obtain copies of OSHA 10-hour cards for all employees working onsite.

b) Verify that the contractors and subcontractors complete the www.constructsecure.com registration and has a score >80 prior to commencing work.

c) Ensure that the installation contractor Site Accident Prevention Plan (APP) is compliant with OSHA and the Army Corps of Engineers.

Activity Hazard Analysis (AHA) must be included with a diagram of the activity area(s) (i.e. staging, transport, install, etc.).

d) Obtain CV/resume for contractor Site Safety and Health Officer (SSHO), defined by the Army Corps of Engineers EM385-1-1 definition 01.A.17, and 01.A.19. Note: The SSHO is to be onsite at all times that work is occurring.

6. Quantity: One adjoined pair of two hot-cells.

7. Delivery Date: Purchase within fiscal year 2020. Delivery is anticipated in Fall 2020 but will depend on acceptance of assembled hot-cells and readiness of the reconstructed laboratory area in PRSS for reassembly of delivered hot-cells (in disassembled format).

8. Period of Performance: No software items pertain to this purchase. A maintenance agreement is not part of this purchase (our current hot-cells are not covered under a maintenance agreement). The hot-cells will have a one-year manufacturer warranty.

9. Option(s): There will be no further options on this purchase.

https://www.ors.od.nih.gov/sr/dohs/Documents/Affirmation%20of%20Contractor%20Safety%20Deliverable.pdf https://www.ors.od.nih.gov/sr/dohs/Documents/Affirmation%20of%20Contractor%20Safety%20Deliverable.pdf http://www.constructsecure.com/ https://www.ors.od.nih.gov/sr/dohs/Documents/Activity%20Hazard%20Analysis.pdf https://www.publications.usace.army.mil/Portals/76/Publications/EngineerManuals/EM_385-1-1.pdf