Biomarker Generator Site Planning Guide

ABT Molecular Imaging, Inc.

Biomarker Generator
Site Planning Guide

530991726A

Biomarker Generator Site Planning Guide

530991726A

Table of Contents

TableofContents
1.0

GeneralInformationandIntroduction.................................................................................................4

2.0

BiomarkerGeneratorPlanningServices..............................................................................................5

2.1. Project Management Services.........................................................................................................5

1. Conceptual Layout of the Biomarker Generator Room and Support Areas.............................5
2. Visits to the Site (3)...........................................................................................................................5
2.2. Site Evaluation...................................................................................................................................5
2.3. Site Plan..............................................................................................................................................5
3.0 List of Responsibilities for Facility Planning/Construction and Equipment Installation................6
4.0 General Specifications.........................................................................................................................10
4.1. Architectural Requirements............................................................................................................10
4.1.1 Floor Space Required...............................................................................................................10
4.1.2 Biomarker Generator Delivery Route.....................................................................................10
4.1.3 Ceiling Height.............................................................................................................................10
4.1.4 Floor Conditions.........................................................................................................................10
4.1.5 Interior Finish..............................................................................................................................10
4.1.7 Local Codes................................................................................................................................11
4.2. Mechanical Requirements..............................................................................................................11
4.2.1 Air Handling and Conditioning.................................................................................................11
4.2.2 Heat Dissipation (Ambient Air)................................................................................................11
4.3. Plumbing Requirements.................................................................................................................12
4.3.1 Chilled Water..................................................................................................................................12
4.3.2 Floor Drains................................................................................................................................12
4.3.3 Gas Bottles.................................................................................................................................12
4.4 Electrical Requirements...................................................................................................................13
4.4.1 Electrical Service (Biomarker Generator Only).....................................................................13
4.4.2 Lighting and Convenience Outlets..........................................................................................13
4.4.3 Lighting Intensity........................................................................................................................13
4.4.4 Emergency Power.....................................................................................................................13

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4.4.5 Dedicated Data Line..................................................................................................................13

4.5. Additional Requirements.................................................................................................................13
4.5.1 Remote Diagnostics..................................................................................................................13
4.5.2 Radiation Protection and Monitoring......................................................................................14
5.0 Radiation Aspects.................................................................................................................................14
6.0 Pre-Installation Construction Information..........................................................................................15
7.0 Dimensions and Weights of the ABT Biomarker Generator...........................................................17
7.0 Additional Reference Materials...........................................................................................................20
TBD............................................................................................................................................................20
8.0 Revision Log..........................................................................................................................................21

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1.0 General Information and Introduction

This guide provides a summary of the ABT BIOMARKER GENERATOR installation specifications and the
physical, electrical, and environmental requirements of the equipment. Included is a general room layout to
assist the user during the conceptual stage of facility planning. This layout should be used as a starting
point, as the physical layout for a Biomarker Generator room will vary from site to site due to limitations
imposed by available space, existing structure, or building codes.
The ABT Biomarker Generator is an integrated, small, self-shielded particle accelerator and microchemistry system with a quality control module. The system produces individual qualified doses tested to
the current US Pharmacopeia standards. The shielding system of the Biomarker Generator reduces the
gamma and neutron fields generated by operation of the Biomarker Generator and the bombardment of
associated targets to an exposure rate of less than 2mR/hr at the surface of the shields.

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2.0 Biomarker Generator Planning Services

2.1. Project Management Services
1. Conceptual Layout of the Biomarker Generator Room and Support Areas
2. Visits to the Site (3)
1.

2.

3.

Initial visit
1.1. Introduction
1.2. Review space
1.3. Preliminary Plan
1.3.1. Rigging path
1.3.2. Flooring review
1.3.3. Customer workflows
Construction kickoff
2.1. Customer, Contractor and architect drawing review
2.2. Project schedule
2.3. Permit timelines
Final Site Readiness
3.1. Site walk through
3.2. Power review
3.3. HVAC review
3.4. Chilled water review
3.5. Delivery confirmation

The customer is responsible for radioactive materials, pharmacy and other licenses required for the
operation of the Biomarker Generator.

2.2. Site Evaluation

As part of the available services referenced above, the customer will be provided with documents to support
the planning of the Biomarker Generator facility. In order for ABT Project Management to accurately
evaluate your site and preparation of these documents, the Customer must provide the following minimum
information:
1.
2.
3.

Dimensioned Floor Plan

Room or Building Section showing the proposed Biomarker Generator location
Site Photos (if building is existing)

Provision of the following additional information will enable ABT Biomarker Generator Project Management
to refine the drawings more accurately:
1.
2.
3.
4.

Space utilization on the surrounding four sides of the proposed Biomarker Generator location
Space utilization directly above the proposed Biomarker Generator location
Patient, pedestrian, technician and vehicular traffic flow patterns
Applicable regulations for facilities

2.3. Site Plan

Based on the information received, ABT Biomarker Generator Project Management will prepare a drawing
for review and approval by the Customer and Customers Design Team. The site plan will consist of a room
concept, proposed rigging path, room and rigging dimensions and other technical specifications such as
electrical and architectural requirements.

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3.0 List of Responsibilities for Facility Planning/Construction and

Equipment Installation
Within the context of Biomarker Generator facility project development, there are multiple tasks assigned to
the participating parties. The development is broken down into these phases: site planning, facility
construction, rigging, and testing and commissioning. Each of these is discussed in this section.
The following table presents the standard list of responsibilities for the participating project parties.
Additional responsibilities may be defined within the Terms and Conditions of the Purchase Agreement.

Site Planning

1. Cost estimates for modifications, renovation, construction, licensing, and any

other costs analysis related to the facility.

Customer

2. Designate a project leader that will act as the principle contact for
communicating all matters related to site planning and construction of the
facility.

ABT and
Customer

3. Provide the documentation with the specifications for planning the facility
including major component dimensions and weights, room size and
environmental requirements, radiation shielding guidelines, conduit layout,
power requirements, etc.

ABT

4. Generate initial facility layout drawings.

Customer

5. Provide drawings for equipment layout and installation.

ABT

6. Generate all drawings used for the construction of the facility.

Customer

7. Calculate and design all radiation shielding within facility to meet local and
national codes. This includes radiation shielding for: a) Biomarker Generator
room walls, ceiling, and floor b) isotope transfer lines c) other rooms where
radioisotope delivery is requested.

Customer

8. Determine requirements for radiation monitoring system for the facilitys rooms
and air ventilation/exhaust system.

Customer

9. Approve architectural drawings before construction begins.

ABT

10. Apply for all licenses and permits for construction and operation of a
radioisotope producing facility including any permits required for ABT to install
and test the Biomarker Generator at the new facility.

Customer

11. Provide project schedule and scheduling changes.

Customer

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Facility Construction
1. Procure all materials required for the facilitys construction and operation
including all conduits, cable trays, radiation shielding, area radiation monitors,
water plumbing, electrical power outlets and fixtures, electrical power
transformers, water chiller, air conditioning equipment, safety interlock devices.

Customer

2. Ensure that all conduits, cable trays, water piping, and all customer purchased
equipment in general meet local safety code.

Customer

3. Provide electrical power for the Biomarker Generator as specified in Site

Planning Guide

Customer

4. Provide main electrical fused disconnect breaker for the Biomarker Generator
main power.

Customer

5. Provide dedicated electrical transformer for the Biomarker Generator main

power. Minimum 25 kVA

Customer

6. Provide main power lines to main electrical fused disconnect (4 wires: single
phase lines +Neutral + Earth Ground) Conductors should be copper and meet
local code for 208-230 V single-phase, 70 Amperes.

Customer

7. Provide all electrical cables, switches, relays, and other devices

Customer

8. Provide chilled water for the Biomarker Generator as specified in Site Planning
Guide

Customer

9. Provide and install chilled water piping with insulation to designated point at the
Biomarker Generator water cabinet.

Customer

10. Provide and install cut-off valves, temperature and pressure gauges, and flowrate meter on primary facility chilled water lines

Customer

11. Provide room air-conditioning and ventilation for the Biomarker Generator as
specified in Site Planning Guide

Customer

12. Provide and install air-conditioning ventilation monitoring devices for negative
room pressure in the Biomarker Generator room and other rooms where
radioisotope may be present.

Customer

13. Provide rigging access to Biomarker Generator room for the Biomarker
Generator as specified in Site Planning Guide.

Customer

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Rigging the Biomarker Generator into the Facility

1. Inspect site for facility readiness to install the Biomarker Generator.

ABT

2. Provide clear entrance with adequate space to deliver the Biomarker Generator
to the entrance of the Biomarker Generator room. NOTE: The Biomarker
Generator will be packed and shipped on a single flat bed trailer. The truck
hauling the Biomarker Generator must have clear access to a landing pad 8 X
8 adjacent to the Biomarker Generator room. If this is not possible then the
scope of work will be outside of the standard rigging.

Customer

3. Rigging of the Biomarker Generator into the facility. Unless otherwise stated on
the sales agreement.

Customer

4. Providing crane, forklift, and other heavy rigging equipment for installing the
Biomarker Generator. Unless otherwise stated on the sales agreement.

Customer

5. Providing specialized fixtures for lifting and moving the major Biomarker
Generator components.

ABT

6. Providing supervision for rigging the Biomarker Generator into the facility

ABT

Biomarker Generator Installation and Testing

1. Ensure that the facility is ready to begin the installation and that all conditions
related to facility electrical, ventilation, water, etc. meet the specifications in the
Site Planning Guide. NOTE: ABT will only start the installation when all items on
the Site Planning Guide Check-off sheet are complete. The Customer must
complete this list and send a copy to ABT prior to beginning the installation.

Customer

2. Provide and install regulators with CGA fittings on gas cylinders. ABT will
provide the initial lecture size bottle of hydrogen and the customer must provide
a medium sized bottle of Argon and regulator for chemistry and accelerator
operation.

Customer

3. Connect the Biomarker Generator main power lines to the main fused
disconnect (4 wires: Single-phase lines +Neutral + Earth Ground)

ABT

4. Inform ABT personnel of all special safety and regulatory procedures that must
be followed during installation.

Customer

5. Provide tools and equipment for routine maintenance and general

housekeeping (i.e., broom, mop, buckets, hand tools, drill, vacuum cleaner, etc.)

Customer

6. Provide specialized tools and equipment for installation.

ABT

7. Assemble and connect all Biomarker Generator components.

ABT

Biomarker Generator Site Planning Guide

8. Optimize and test the Biomarker Generator (IQ, OQ)

9. Provide standard laboratory equipment and consumables (i.e., latex gloves,
glass and plastic wear, syringes, medical vials, de-ionized water, acetone,
methanol, etc.)
10. Perform acceptance testing (PQ)

ABT
Customer

ABT

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4.0 General Specifications

4.1. Architectural Requirements
4.1.1 Floor Space Required
A Biomarker Generator room will include the self-shielded accelerator including a control cabinet, an ISO 5
chemistry and QC area, and an operators console and utilities access adjacent to the shielding. In
addition, ABT will provide a 20 kW water-to-water chiller which should be installed in a separate location.
The room is recommended to have inside dimensions of 18ft X 18ft (5.5m X 5.5m) clear INSIDE room
dimensions.
Radioactive products from the Biomarker Generator are delivered directly to the Biomarker Generator
chemistry area attached to the Biomarker Generator shields. An option is available to allow radioisotope
from the Biomarker Generators targets to be delivered to customers own hot cell or adjacent to a
Biomarker Generator. In this case, a second operators console can be located adjacent to the customers
hot cell. The facility design must include conduits and shielding for delivery of the product from the
Biomarker Generator to the customer designated areas. Delivery to hot cells or chemistry areas other than
adjacent to the Biomarker shielding must be within 15 ft. (4.5m) of the shielding.
Additional space for the storage of spare parts, tools and consumables in close proximity to the Biomarker
Generator room is recommended. In addition, the customer must provide an area for long-lived waste
storage. A minimal amount of waste is expected so an area no more than 2ft X1ft X1ft will be sufficient.
4.1.2 Biomarker Generator Delivery Route
The Biomarker Generator will be delivered through any opening with a minimum of 48in (1.22m) in width
and 7ft (2.13m) tall. If the delivery path utilizes internal corridors, the path must have clear dimensions of at
least 48in (1.22m) wide by 8 ft. (2.44m) high. The delivery path must also be structurally capable of
handling a dynamic load of 8,000 lbs (3,600 kg) during delivery. The clear working height inside the room
during Biomarker Generator rigging shall be a minimum height of 8 ft. (2.44m).
4.1.3 Ceiling Height
The minimum height of the interior finished ceiling of the Biomarker Generator room is 8.0 ft. (2.44m).
4.1.4 Floor Conditions
Surface finish flatness: 1/8 in. (3mm) over 10 ft. (3.0m) run
Thickness: Six inch cement slab with a layer of number five rebar in one foot centers at a depth of three
inches.
4.1.5 Interior Finish

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The ceiling and interior walls of the Biomarker Generator room can be finished to the customer's desired
specification. It is recommended that the floor be covered with a seamless vinyl covering for ease of
cleaning. In addition, the Biomarker Generator room should have low particulate ceiling tiles.
4.1.7 Local Codes
If local construction codes conflict with the specifications in this guide, the local codes will overrule
specifications. The resulting change, as well as the final design, must be accepted by ABT before
construction begins. Changes effected after acceptance of final design may seriously affect the time
required to install the Biomarker Generator once it arrives on your site. For this reason, designers,
contractors, and subcontractors should work closely with the ABT Project Manager on all proposed changes
to the accepted design.

4.2. Mechanical Requirements

4.2.1 Air Handling and Conditioning
The Biomarker Generator room shall be maintained at negative pressure relative to the surrounding areas.
Ambient temperature: 70F 8F (21C 3C)
Relative humidity: 40%-55%, non-condensing
It is recommended that the customer provide an appropriate monitor with an audible alarm to insure that the
differential pressure between spaces is maintained. It is also recommended that the customer provide an
appropriate visual humidity monitor with an audible alarm to ensure that the specified humidity levels are
maintained. It is the responsibility of the customer to ensure that the exhaust control and monitoring system
complies with applicable state and local regulations.
4.2.2 Heat Dissipation (Ambient Air)
Biomarker Generator: 23,373 Btu/h (6.9 kW) which will be reduced to 10,748 BTU (3,150 kW) by a 20 kW
water-to-water chiller supplied by ABT. Customer will provide chilled water source. If customers facility
does not have access to an acceptable chilled water source, ABT can provide specifications for an air to
water option.
Biomarker Generator Cooling Water Requirements
Component
RF Cabinet
Magnet
RF
Ion Source
Target
Mechanical Pump
Utility Cabinet
Chemistry
Chiller**
Net kW/HR

kW/Hr
500
2,000
4,000
100
40
60
100
50
6,850**

Heat Exchange via

Outside/Water-to-Water Chiller
(1,500)
(2,000)
(100)
(40)
(60)
(2,700)

Net Heat Load to

HVAC
500
500
2000
100
50
3,150*

* 3,150 kW = ~ 11,000 BTUs = ~ 1 ton HVAC required

** If indoor air-to-water required, additional 2,500 kW in heat from chiller = 9,350 kW = ~32,000 BTUs = 2.6 ton HVAC

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Note: The facility air handling and conditioning system must automatically compensate for the changing load
conditions that occur when the Biomarker Generator is operating (maximum heat dissipated to the air) and when the
Biomarker Generator is at rest (minimum heat dissipated to the air). Under NO circumstances is the heat load from the
cabinets and the Biomarker Generator to be assumed as available for supplemental humidity control. Such
consideration will result in reduced cooling capacity provided to this room during Biomarker Generator operations.

4.3. Plumbing Requirements

4.3.1 Chilled Water
A 20 kW heat exchanger and deionizer water system adequate to maintain the Biomarker Generator and
ancillary equipment is provided by ABT. The customer must supply chilled water to the heat exchanger as
follows:
Inlet water temperature: 45 F 5 F (7 C 3C)
Required flow rate: 10 gal/min (38 L/min)
Heat exchanger load: 70,000 Btu/h (20.5 kW) at full load
Max inlet water pressure: 40 psig (37.9 l/min)
Supply line CX: 1 in. NPT Female
Return line CX: 1 in. NPT Female
The party providing the external cooling system is responsible for connecting the chilled water to the ABT
water recirculation system and for installing a manual cutoff valve, pressure and temperature gauges, and a
flow meter to monitor chilled water parameters.
If an existing chilled water plant of sufficient thermal/volumetric capacity is to be utilized, the system must
be operational continuously. All reductions/restrictions/outages must be coordinated with the Biomarker
Generator staff as a loss of chilled water results in Biomarker Generator shutdown.
Note: The chilled water system must automatically compensate for the changing load conditions that occur when the
Biomarker Generator is operating and at rest.

4.3.2 Floor Drains

The 20 kW water-to-water chiller contains less than 3 gallons of water at any one time and therefore a floor
drain is not necessary. There is no constant drainage from the Biomarker Generator. A floor drain can be
added by the customer if required by local building codes.
4.3.3 Gas Bottles
A cylinder of hydrogen gas is required for the system. ABT provides the initial hydrogen container (less than
one liter) and regulator which will be contained in the utility enclosure provided with the Biomarker
Generator. A medium sized bottle of Argon is required for the operation of the Biomarker Generator which
is to be supplied by the customer, as well as the appropriate regulators. The location of the Argon gas does
not have to be in the Biomarker Generator room but must be within 50 feet of the Biomarker Generator.
The production of future radioisotopes may have additional gas requirements which will increase the total
gas bottles required. Installation of a secure, approved mounting system and any signage required is the
responsibility of the customer.

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4.4 Electrical Requirements

4.4.1 Electrical Service (Biomarker Generator Only)
Main disconnect: 208 - 230V, 70 A, single-phase, fused disconnect, with slow blow fuses, provided and
installed by the customer
Regulation: 5% of nominal voltage (not to be less than 200 VAC during full load)
Lines: 2 single phase lines, 1-neutral and 1-insulated ground (copper)
Ground: separate copper rods driven into the earth outside the facility (if not already provided)
Power draw: ~ 15 kVA
Note: This power is dedicated to the Biomarker Generator only.
4.4.2 Lighting and Convenience Outlets
Interior lighting, environmental conditioning equipment, general purpose receptacles, and any other
electrical functions must be powered from an electrical panel that is independent of the Biomarker
Generator power supply.
4.4.3 Lighting Intensity
Lighting levels during normal operation are at the discretion of the customer.
4.4.4 Emergency Power
No emergency power is required for the operation or protection of the BIOMARKER GENERATOR. It is
recommended that an uninterrupted power supply (UPS) with battery backup be provided for the control
station with a minimum battery backup time no less than thirty (30) minutes.
4.4.5 Dedicated Data Line
A dedicated Ethernet line located near the control console is required for system support.

4.5. Additional Requirements

4.5.1 Remote Diagnostics

The Remote Diagnostics Option for the Biomarker Generator system allows for the monitoring and
diagnosis of remote systems without a special service engineer visit to the site. This option allows ABT
service technicians to connect to the remote site, observe the actions of the local site personnel and control
system responses, and intervene to run diagnostics or other data gathering functions. This service is
available 24 hours a day and provides remote sites with the best service support possible. The method of
connection to the remote site will vary from site to site depending on the infrastructure the customer has
chosen or the infrastructure that is available to the customer. All sites require LogMeIn remote control
software package for this purpose.
It is very important that the planning for Remote Diagnostics occurs early in the Site Planning phase of a
project. The infrastructure needs to be in place by the time the Installation Engineer arrives to connect,

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start-up and test the Biomarker Generator. This allows the capability to be used during the installation
process, which shortens the overall installation time.
ABT will coordinate the configuration of the network with the customers network manager, who will be
responsible for setting up and maintaining security and access.
4.5.2 Radiation Protection and Monitoring
The ABT Biomarker Generator produces Fluorine at the millicurie level. The Biomarker Generator room
must be a controlled radiation area for badged workers. The shielding is designed to result in a radiation
measurement of less than 2 mR/hr on the shield surface. Radiation survey monitors for the facility shall be
provided by the customer. The room dimensions and self-shielding will allow rooms outside the Biomarker
Generator room to be general occupancy with standard 8 cinderblock walls.
The Biomarker Generator will be exhausted into the room without additional connection to the facilities
HVAC system. Based upon the 5000 L internal volume and the cooling airflow through the shield, ABT
estimates that exposure from activation of air from operation of the cyclotron for a single 20 minute run
would be at least a factor of 1000 less than the regulatory limits of 50 mR/yr and 2 mR/hr.
Some jurisdictions may have different requirements with respect to pressure requirements within the
cyclotron room and exhaust monitoring. For additional information, consult your local Radiation Safety
Officer and ABT.

5.0 Radiation Aspects

DoseCalculationsfromtheABTBiomarkerGeneratorprototypewith1AontargetarereflectedinFigure
3.

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6.0 Pre-Installation Construction Information

The following pre-installation construction is the customer's responsibility.

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Provision of a concrete loading/unloading/staging pad with a minimum size of 10 ft. by 12 ft. (3.05m
by 3.6m) next to Biomarker Generator entranceway. The size of this pad must be increased to
accommodate for any building eaves that overhangs the entranceway in a depth greater than 12 in.
(30.5 cm). Contractors shall coordinate the location of this pad with Project Management Planning
staff.

A stable, compacted surface for routing the delivery trucks and rigging equipment that will be
brought onto the site. The surface must be capable of supporting the weight of the trucks and
equipment. Recommended surfaces are asphalt paving, concrete paving, or steel plate over a
compacted subsurface. ABT is not responsible for any structural improvements needed to bring
heavy equipment on site for the rigging of the Biomarker Generator. ABT will not be responsible for
repairs to surfaces that are not sufficient to support the applied loads.

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7.0 Dimensions and Weights of the ABT Biomarker Generator

Figure 1 ABT Biomarker Generator

E&F

E&F

A
B&C

B&C

A1 A3

A1A3

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I

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Dimensions, Weight and Floor Load of the Biomarker Generator

Item

Description

Width in

Diameter

Depth in

Height in

Accelerator

48

42

7,000 (3,200)

B&C

Lower Shields
(Stationary)

27

10,000 (4,550) Total

5,000 (2,300) / each

Floor Shielding
(Not Pictured)

48

14

3,900 (1,800)

E&F

Top Shields

37

13,400 (6,100) Total

6,700 (3,050) / each
500 (230)

Control Cabinet

28

32

78

Water-to-Water Chiller

14.5

27.6

22.6

TOTAL ACCELERATOR

168 (76)
34,968 (15,895)

A1 A3

Accelerator Legs

B&C

Floor Load Top Down

48

64

*700 (320) / sq foot

G (3)

Screw Jacks Top Up

12

48

12

94

*4,400 (2,000) /sq foot

*2,400 (1,100) / each

Chemistry Table

52

30

40

1,100 (500)

Table w/ Laminar Flow

Hood

52

30

80

1,300 (600)

19

Weight lb (kg)/
*Floor Load lb (kg)

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7.0 Additional Reference Materials

Following is a list of additional documents that can be obtained from ABT for site planning purposes:

TBD

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8.0 Revision Log

ECONumber
201004007

EffectiveDate
04/16/2010

Revision
A

Pages
All

21

ReasonforRevision
InitialIssue

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