ABT Molecular Site Planning Guide

Biomarker Generator Site Planning Guide 530‐99‐1726 A

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ABT Molecular Imaging, Inc.

Biomarker Generator Site Planning Guide


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Table of Contents

Table of Contents 1.0 General Information and Introduction ................................................................................................. 4

2.0 Biomarker Generator Planning Services .............................................................................................. 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 micro-chemistry 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. 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

2. Construction kickoff 2.1. Customer, Contractor and architect drawing review 2.2. Project schedule 2.3. Permit timelines

3. 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. Dimensioned Floor Plan 2. Room or Building Section showing the proposed Biomarker Generator location 3. 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. Space utilization on the surrounding four sides of the proposed Biomarker Generator location 2. Space utilization directly above the proposed Biomarker Generator location 3. Patient, pedestrian, technician and vehicular traffic flow patterns 4. 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 Customer’s 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 facility’s 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 facility’s 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 flow-rate 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


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

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

Customer

10. Perform acceptance testing (PQ) 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 operator’s 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 Generator’s targets to be delivered to customer’s own hot cell or adjacent to a Biomarker Generator. In this case, a second operator’s console can be located adjacent to the customer’s 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: 70°F ± 8°F (21°C ± 3°C) 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 customer’s 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 kW/Hr Heat Exchange via Outside/Water-to-Water Chiller

Net Heat Load to HVAC

RF Cabinet 500 - 500 Magnet 2,000 (1,500) 500 RF 4,000 (2,000) 2000 Ion Source 100 (100) - Target 40 (40) - Mechanical Pump 60 (60) - Utility Cabinet 100 - 100 Chemistry 50 - 50 Chiller** - Net kW/HR 6,850** (2,700) 3,150* * 3,150 kW = ~ 11,000 BTU’s = ~ 1 ton HVAC required ** If indoor air-to-water required, additional 2,500 kW in heat from chiller = 9,350 kW = ~32,000 BTU’s = 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 ± 3°C) 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 customer’s 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

Dose Calculations from the ABT Biomarker Generator prototype with 1 µA on target are reflected in Figure

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

A

B & C

E & F

GG

G

A1 – A3

A

E & F

B & C

A

A1 – A3


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J I

H


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Dimensions, Weight and Floor Load of the Biomarker Generator

Item Description Width in Diameter Depth in Height in Weight lb (kg)/

*Floor Load lb (kg)

A Accelerator - 48” - 42” 7,000 (3,200)

B&C Lower Shields (Stationary)

- 8’ - 27” 10,000 (4,550) Total 5,000 (2,300) / each

D Floor Shielding (Not Pictured)

- 48” - 14” 3,900 (1,800)

E & F Top Shields - 8’ - 37” 13,400 (6,100) Total 6,700 (3,050) / each

H Control Cabinet 28” - 32” 78” 500 (230)

I Water-to-Water Chiller 14.5” - 27.6” 22.6” 168 (76)

TOTAL ACCELERATOR 34,968 (15,895)

A1 – A3 Accelerator Legs 7” - 4” ¾” *2,400 (1,100) / each

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

J Chemistry Table 52” - 30” 40” 1,100 (500)

Table w/ Laminar Flow Hood

52” - 30” 80” 1,300 (600)


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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

ECO Number Effective Date Revision Pages Reason for Revision

201004007 04/16/2010 A All Initial Issue

Documents

ABT Molecular Site Planning Guide