Statement_of_Work-Rev13.docx

Extrusion Plant Radiographic Inspection System (EPRIS) Statement of Work

1.0 GENERAL REQUIREMENTS

The contractor shall deliver a complete turn-key installation of a cabinet radiographic inspection system certified to 21CFR1020.40, labeled under 21CFR1010.2 & 21CFR1010.3 and installed at IHEODTD at Indian Head, MD.

1.1 The contractor shall perform any and all engineering work required to meet all aspects of the system specifications. The full design and function of the system will be engineered by the contractor.

1.2 This equipment will radiographically inspect different similar sized energetic items meeting the inspection criteria listed in this specification.

1.3 The system shall perform semi-automated Computed Tomography inspections with minimal interaction required by the operator other than loading the items, identifying the items and starting the scan. CT reconstructions shall be done automatically once the reconstruction settings have been determined.

1.4 System will consist of an inspection cabinet, an operator station and a review station.

1.4.1 The Operator Station shall have all controls necessary for the complete manual and automatic operation of the radiographic inspection system and shall include a video surveillance system enabling the operator to see the entire X-ray inspection operation and a review all x-ray images.

1.4.2 A Reviewing Station shall be located in the Office Area adjacent to the Inspection Facility and shall contain all the necessary computer, storage and display equipment specified herein to enable complete review of X-ray results.

1.5 Any handling items shall not cause damage to the energetic items. Assume a minimum durometer of 80A for all energetic items.

1.6 The contractor will design an adaptor for securing the energetic items to the inspection platform in the cabinet. The adaptor will be unique for each energetic item and must be capable of being removed from the cabinet for attachment to the energetic items. All items will be fitted with an adaptor before entering the cabinet. The adaptor shall not damage the items. The adaptor must fully support the items while the inspection is occurring. The adaptor must not interface with the bore of the energetic item; it must use the outside diameter of the energetic item for support.

1.7 Items 5 and 6 will require a tube and adaptor combination for inspecting the items. The tube will cover the entire item and create an air tight seal around the energetic item. The tube shall be uniform in thickness and composition over the length of the item to ensure that the tube does not create artifacts or otherwise negatively impact the quality of static DDA images or CT reconstructions.

1.8 The contractor shall have a robust quality and documentation system and be certified to ISO 9001.6t

2.0 APPLICABLE DOCUMENTS

The following documents are mandatory and the contractor shall meet all applicable requirements at the time of contract award.

2.1 GOVERNMENT DOCUMENTS

U.S. Department of Labor: General Industry, OSHA Safety Health Standards (21 CFR Subpart J) CFR Title 29, Chapter XVII, Part 1910 – Occupational Safety and Health Regulations.

FDA regulation 21CFR1020.40, 21CFR1010.2, and 21CFR1010.3

2.2 NATIONAL FIRE PROTECTION ASSOCIATION

NFPA Standards 70- National Electric Code

NFPA Standards 79- Electrical Standard for Industrial Machinery

2.3 ASTM DOCUMENTS

ASTM E1255 – Standard Practice for Radioscopy

ASTM E1411 – Standard Practice for Qualification of Radioscopic Systems

ASTM E1570 – Standard Practice for Computed Tomographic (CT) Examination

ASTM E1695 – Standard Test Method for Measurement of Computed Tomography (CT) System Performance

ASTM E1742 - Standard Practice for Radiographic Examination

ASTM E2339 - Standard Practice for Digital Imaging and Communications in Nondestructive Evaluation (DICONDE)

ASTM E2597 – Standard Practice for Manufacturing Characterization of Digital Detector Arrays

ASTM E2698 – Standard Practice for Radiological Examination using Digital Detector Arrays

ASTM E2737 - Standard Practice for Digital Detector Array Performance Evaluation and Long-Term Stability

SMPTE RP 133 – Specifications for Medical Diagnostic Imaging Test Pattern

ANSI/IEEE C62.41 and C62.45 - IEEE Recommended Practice for Surge Voltages in Low-Voltage AC Power Circuits

3.0 SAFETY AND ENVIRONMENTAL REQUIREMENTS

3.1 MERCURY RESTRICTION

The equipment shall not contain mercury compounds, nor be exposed to free mercury during manufacture.

3.2 ASBESTOS RESTICTION

Asbestos and materials containing asbestos shall not be used in or on the equipment.

3.3 PCB RESTRICTION

Equipment and materials containing Polychlorinated Biphenyl (PCB) shall not be used in or on the equipment

4.0 UTILITY & SPACE REQUIREMENTS

4.1 The radiographic inspection system shall operate from nominal 120/208 volt, 4 wire, 3 phase, 60 HZ input power.

4.2 The power for the radiographic inspection system will be supplied from a disconnect switch located in the Inspection Facility.

4.3 The contractor shall be responsible for providing all conduit and wiring from the disconnect switch to the radiographic inspection system.

4.4 The contractor shall be responsible for supplying any additional wiring required for complete operation of the Radiographic inspection system including interconnection between equipment cabinets, Operator Station and Reviewing Station.

4.5 The contractor shall be responsible for providing and installing any piping and tubing for any compressed air or cooling equipment.

4.6 Uninterruptible power supplies shall be provided to carryover all control power, safety circuits, computer controls, Operator Station, Reviewing Station and other necessary functions to permit an orderly shutdown of the radiographic inspection system without any loss of data or corruption of files in event of the 120/208 main power loss. Power conditioning systems shall be provided on all incoming power to the following specification: Lightning, surge & noise protection 2000:1 spike attenuation using ANSI/IEEE C62.41 and C62.45 Category A and Category B tests. Common mode: >120 dB. Normal mode: >60 dB.

4.7 The radiographic inspection system shall meet all the requirements of this specification when located in the Inspection Facility that will have the following ambient conditions:

4.7.1 Temperature: 60 to 85° F.

4.7.2 Humidity; 30 to 70% Relative Humidity.

4.8 The radiographic inspection system shall be installed in the Inspection Facility of Building 1384 at IHEODTD. All required equipment shall be located inside the inspection facility. A dimensional layout of the Inspection Facility with conceptual equipment location is shown in Figure 1. Assume a height maximum of 10’ of useable space. Two carts of size 30” by 60” shall be able to maneuver into the facility and remain stationary during the inspection process while one cart of size 30” by 60” shall be able to maneuver into the facility and into the inspection system loading position and then be removed from the bay after inspection is complete.

4.9 All X-ray generators and coolers shall be placed in the non-electrically rated equipment room in the inspection facility.

4.10 Any heat exchanger cooling equipment shall be in suitable enclosures.

Office Equipment Room

Figure 1. Building 1384 - Extrusion Radiographic Inspection System Facility.

5.0 DESCRIPTION OF ITEMS TO BE INSPECTED

The Radiographic inspection system shall be capable of 100% inspection of four different energetic items in DDA or CT modes. Assume mass density of Magnesium for item 1 and 3 material and for the center material of item 2 and 4.

5.1 Item 1

Energetic item 1 is shown in Figure 2.

Figure 2 Item #1

5.1.1 Item 1 shall be attached to an adaptor and placed in the cabinet to be 100% radiographically inspected along its 32.066” length, 2.55” diameter using CT. Assume a chord length of 1.7” and a material that is radiographically similar to magnesium.

5.1.2 Quality Level shall be demonstrated to be 2-1T on item 1

5.1.3 Item 1 shall be radiographically inspectable with a spiral CT scan in a single scan.

5.1.4 Item 1 shall also be radiographically inspected with a 3-D cone beam of multiple scans with overlap to allow for 100% coverage.

5.1.5 Indications for identification - The radiographic inspection system identify and characterize:

5.1.5.1 Voids greater than 0.080”

5.1.5.2 Fissures longer than 0.080”

5.1.5.3 Cracks longer than 0.080”

5.1.5.4 Foreign Material larger than 0.120”

5.1.6 Additional Quality Test

5.1.6.1 For qualification, the following size/type indicators shall be attached to the outside diameter of item 1 in the orientation listed and shall be clearly discernable in the CT reconstruction:

5.1.6.1.1 2-1T magnesium (Mg) hole in 1.7-inplaque

5.1.6.1.2 0.030 in Mg wire, perpendicular to bore

5.1.6.1.3 0.030 in Mg wire, parallel to bore

5.1.6.1.4 0.040 in Mg wire, parallel to bore

5.1.6.2 The system shall be able to detect all defect features in an inert plastic sample with a minimum feature size of 0.030” An example of one of these samples is shown in Figure 3 (with the small hole shown with the red arrow). Half of the sample is shown in the Figure. The sample may be manufactured in halves but the CT scan must be done with the two halves together to simulate the cross section of the actual item.

5.1.6.2.1 A sample of Figure 3 will be provided to the contractor for testing purposes.

5.1.6.2.2 All 4 holes and 23 slots shall be detected.

5.1.6.2.3 The material in this sample is radiographically similar to magnesium.

Figure 3 Inert Sample

5.2 Item 2

Energetic item 2 is shown in Figure 4.

Figure 4 Item #2

5.2.1 Item 2 shall be attached to an adaptor and placed in the cabinet to be 100% radiographically inspected along its 60.5” length, 4.686” diameter using CT. Assume a chord length of 4.5” and a material that is radiographically similar to magnesium.

5.2.2 Quality Level shall be demonstrated to be 2-1T on item 2

5.2.3 Item 2 shall be radiographically inspectable with spiral CT scans. It is permissible to scan one end of the item, open the cabinet, flip the item and scan the other end of the item.

5.2.4 Item 2 shall also be radiographically inspected with a 3-D cone beam of multiple scans with overlap to allow for 100% coverage.

5.2.5 Indications for identification - The radiographic inspection system identify and characterize:

5.2.5.1 Voids greater than 0.100”

5.2.5.2 Fissures longer than 0.250”

5.2.5.3 Cracks longer than 0.250”

5.2.5.4 Foreign Material larger than 0.120”

5.3 Energetic item 3, shown in Figure 5

Figure 5

5.3.1 Item 3 shall be attached to an adaptor and placed in the cabinet to be 100% radiographically inspected along its 41.828” length, 2.75” diameter using DR and CT. Assume a chord length of 1.7” and a material that is radiographically similar to magnesium inside of a steel case. The steel case will be assumed to have a wall thickness of 0.072”.

5.3.2 Quality Level shall be demonstrated to be 2-1T on item 3

5.3.3 Item 3 shall be radiographically inspected with a spiral CT scan in a single scan.

5.3.4 Item 3 shall also be radiographically inspected in accordance with ASTM E2698 in 2-dimensional DDA mode.

5.3.4.1 Images on six azimuths shall be acquired at 0, 30, 60, 90, 120, and 150.

5.3.4.2 Axial overlap of images shall be taken to assure complete coverage.

5.3.5 Indications for identification - The radiographic inspection system identify and characterize:

5.3.5.1 Voids greater than 0.080”

5.3.5.2 Fissures longer than 0.080”

5.3.5.3 Cracks longer than 0.080”

5.3.5.4 Foreign Material larger than 0.120”

5.3.5.5 Crack or groove in exterior tube

5.3.5.6 Bent metal spacer or spacer spring

5.3.5.7 Cut or twisted sealing ring

5.3.5.8 Cut or twisted O-ring

5.3.5.9 O-ring does not contact item tube

5.3.5.10 Bent rod basket

5.3.5.11 Cover contacting item tube bulkhead (Mods 2 and 3 only)

5.3.5.12 Outer or inner shield not seated

5.3.5.13 Shields do not over-lap

5.3.5.14 Forward wire connector not wrapped to rod

5.3.5.15 Forward assembly not seated or cocked

5.4 Energetic item 4, shown in Figure 6

Figure 6

5.4.1 Item 4 shall be attached to an adaptor and placed in the cabinet to be 100% radiographically inspected along its 76.067” length, 5.125” diameter using DR, RTR and CT. Assume a chord length of 4.5” and a material that is radiographically similar to magnesium inside of a steel case. The steel case wall thickness can be assumed to be 0.171”

5.4.2 Radiographic Contrast Sensitivity shall be demonstrated to be 2-1T on item 4

5.4.3 Item 4 shall be radiographically inspectable with spiral CT scans. It is permissible to scan one end of the item, open the cabinet, flip the item and scan the other end of the item.

5.4.4 Item 4 shall also be radiographically inspected in accordance with ASTM E2698 in 2-dimensional DDA mode.

5.4.4.1 Images on six azimuths shall be acquired at 0, 30, 60, 90, 120, and 150 degrees

5.4.4.2 Axial overlap of images shall be taken to assure complete coverage.

5.4.5 Indications for identification - The radiographic inspection system identify and characterize:

5.4.5.1 Voids greater than 0.100”

5.4.5.2 Fissures longer than 0.250”

5.4.5.3 Cracks longer than 0.250”

5.4.5.4 Foreign Material larger than 0.120”

5.4.5.5 Spring is seated on end inhibitor groove

5.4.5.6 Retaining ring properly installed into tube groove

5.4.5.7 Knot in wire is present

5.4.5.8 Rubber pad(s) are in their proper location

5.4.5.9 Wire is located in the center of grain and not pinched between components or broken

5.4.5.10 O-ring is present and seated in the tube o-ring groove

5.4.5.11 Three retaining ring locks are present and properly installed. The locks are not equally spaced, but are in a 12, 3, 6 o-clock configuration.

5.5 Energetic item 5

5.5.1 Item 5 is similar in nature to item 1. Item 6 must be fully incased with a tube and adaptor before entering the cabinet. Item 5 shall be 100% radiographically inspected along its 32.0” to 32.5” length, 2.5” to 2.75” diameter using CT. Assume a chord length of 1.7” and a material that is radiographically similar to magnesium.

5.5.2 Quality Level shall be demonstrated to be 2-1T on item 5

5.5.3 Item 5 shall be radiographically inspectable with a spiral CT scan in a single scan.

5.5.4 Item 5 shall also be radiographically inspected with a 3-D cone beam of multiple scans with overlap to allow for 100% coverage.

5.5.5 Indications for identification - The radiographic inspection system identify and characterize:

5.5.5.1 Voids greater than 0.080”

5.5.5.2 Fissures longer than 0.080”

5.5.5.3 Cracks longer than 0.080”

5.5.5.4 Foreign Material larger than 0.120”

5.6 Energetic item 6

5.6.1 Item 6 is similar in nature to item 2. Item 6 must be fully incased with a tube and adaptor before entering the cabinet. Item 6 shall be 100% radiographically inspected along its 61.125 to 61.5” length, 4.61” to 4.86” diameter using CT. Assume a chord length of 4.5” and a material that is radiographically similar to magnesium.

5.6.2 Quality Level shall be demonstrated to be 2-1T on item 6

5.6.3 Item 6 shall be radiographically inspectable with spiral CT scans. It is permissible to scan one end of the item, open the cabinet, flip the item and scan the other end of the item.

5.6.4 Item 6 shall also be radiographically inspected with a 3-D cone beam of multiple scans with overlap to allow for 100% coverage.

5.6.5 Indications for identification - The radiographic inspection system identify and characterize:

5.6.5.1 Voids greater than 0.100”

5.6.5.2 Fissures longer than 0.250”

5.6.5.3 Cracks longer than 0.250”

5.6.5.4 Foreign Material larger than 0.120”

5.7 Tubes and Adaptors

5.7.1 The contractor will provide 200 adaptors for item 1

5.7.2 The contractor will provide 50 adaptors for item 2

5.7.3 The contractor will provide 12 adaptors for item 3

5.7.4 The contractor will provide 6 adaptors for item 4

5.7.5 The contractor will provide 200 adaptors and 200 tubes for item 5

5.7.6 The contractor will provide 50 adaptors and 50 tubes for item 6

5.7.7 The contractor will provide detailed drawings of the tubes and adaptors for reproduction. (CDRL A008)

6.0 QUALITY REQUIREMENTS

6.1 Compliance to ASTM Specifications

6.1.1 For all items in all modes of operation, Normalized Image Unsharpness shall meet the requirements of ASTM E2698. Software shall automate the calculation of Normalized Image Unsharpness and Geometric Magnification.

6.1.2 Images shall meet all requirements of ASTM E2698.

6.1.3 Bad pixels shall be identified, documented and corrected in accordance with the requirements of ASTM E2597 and E2737. The process for correcting bad pixels shall be automated and addressed in the operating manuals for the system.

6.1.4 System shall automate all tests and calculations required to perform the testing required for ASTM E1570, E1695, E2698 and E2737. Two sets of all tools and gauges required for long term stability testing shall be provided. All gauges and image quality indicators (IQIs) shall be provided with documentation of calibration. System shall generate all reports required by ASTM E2737 and provide a means to track the performance of the system over time.

6.2 Image Quality

6.2.1 All images and CT reconstructions shall be free of visible artifacts including but not limited to ring artifacts, sample movement, aliasing, beam hardening, bad pixels or interference from holding fixtures or encapsulating tubes.

6.2.2 Images and CT reconstructions taken over the course of a shift (defined as a ten-hour work day) shall not exhibit any change or drift. There shall be no discernable difference in an image or CT reconstruction of the same item taken at the beginning, middle and end of a work day.

6.2.3 System shall calibrate the panel to correct the inhomogenities of the detector and x-ray beam. The process for calibrating the detector shall be automated and addressed in the operating manuals for the system. Contractor shall provide written recommendation for the frequency of calibration.

6.2.4 System shall calibrate to correct for alignment of the x-ray tube, detector and the object being inspected. The process for calibrating the alignment of the system shall be automated and addressed in the operating manuals for the system. Two sets of all tools required for calibration of alignment shall be provided.

7.0 PERFORMANCE REQUIREMENTS

7.1 When performing spiral CT scanning of Item 1, the system shall be capable of inspecting 30 units per hour including loading, data acquisition, CT reconstruction, viewing data, data archival and unloading items utilizing no more than 3 persons for continuous system operation and interpretation. Binning the detector panel to operate at 30 frames per section is allowed for this fast CT scanning mode provided that all performance and image quality requirements are met.

7.2 Cycle times shall be achieved through simultaneous inspection of multiple items on separate spindles. Inspecting multiple items on a single turntable is not an acceptable method of achieving the required cycle times, each item must be rotated about its own central axis for all CT inspections.

7.3 All image quality requirements in section 5 shall be met at these cycle times.

7.4 In addition to the fast CT scanning mode, system shall have the ability to perform a higher resolution scan to characterize defects. This scan mode shall utilize a sub-pixel shifting method to achieve 100 micron resolutions from the 200 micron detector.

8.0 COMPONENT REQUIREMENTS

8.1 Video Surveillance System

8.1.1 Minimum eight camera video surveillance system shall be provided with capability to expand to at least 16 cameras. Minimum video standard NTSC with 960H resolution support

8.1.2 Two cameras shall be placed internal to the cabinet system to observe the inspection process.

8.1.3 Two cameras shall be placed external to the cabinet to observe the loading and unloading process.

8.1.4 Two cameras shall be placed at both entrances to the bay, one looking at outside entrance from the inside and one looking at the inside entrance from the inside.

8.1.5 Two cameras shall be placed in the equipment room.

8.1.6 The video system shall record video of all cameras in the system.

8.1.7 The video system shall automatically initiate video recording upon power up of the inspection system.

8.1.8 The video system shall acquire video at all times while the system is powered up.

8.1.9 Two video monitors of 24” size shall be provided for the video system.

8.1.10 The video surveillance system shall have the capability to routinely back-up the video onto an external device on a daily basis with a minimum 4TB HDD storage.

8.1.11 All cameras must be recorded at a minimum of 4CIF resolution and 30 frames per second.

8.2 Bar Code Reader

8.2.1 The system shall include a barcode reader for reading bar codes on the items.

8.2.2 The system shall read the barcode information from the barcodes attached to the items.

8.2.3 The barcode information shall be attached to the corresponding item radiographic data.

8.2.4 The barcode information shall be written into the DICONDE file in the appropriate data field.

8.2.5 If multiple items are scanned simultaneously, the system shall associate each barcode’s information with the correct item, image data files and DICONDE data file.

8.3 X-Ray Tube

8.3.1 The x-ray tube shall be a metal ceramic tube, oil cooled with a tungsten target and an energy range up to 450kV.

8.3.2 The x-ray tube shall have two focal spots with one being no greater than 0.4mm when measured in accordance with the EN 12543 specification and a continuous power rating of at least 650 watts at this focal spot size.

8.3.3 The x-ray tube is required to have a remotely operated collimator mounted on the tube head. This collimator must be controlled from the control console.

8.3.3.1 The collimator shall have two sets of orthogonally oriented motorized jaws.

8.3.3.2 The position of each set of collimator jaws shall be displayed in the system software. The user shall be able to use the system software to manually open or close each set of jaws or send the jaws to a specific position.

8.3.4 The x-ray tube is required to have a holder for placement of metallic filters at the tube head. A minimum of four metallic filters shall be provided with the system, selected for optimal results when inspecting items 1 through 4.

8.4 Digital Detector Array

8.4.1 The flat panel detector shall be an amorphous silicon based detector.

8.4.2 The detector shall be a premium grade panel, such as a Varex 1621 AN14 ES Premium ASTM grade or equivalent, designed for use with computed tomography systems. The detector shall not be liquid cooled.

8.4.3 The flat panel detector shall be designed for operation at X-ray energies up to at least 450 kV.

8.4.4 The panel shall have radiation sensitive electronics shielded to minimize radiation damage according to the panel manufacturer specifications.

8.4.5 Pixel size shall be 200 x 200 microns.

8.4.6 Pixel matrix shall be 2048 by 2048.

8.4.7 Analog to digital converters shall be 16 bit.

8.4.8 Panel scintillator shall be gadolinium oxysulfide (Gd202S) - DRZ Standard.

8.5 Motion Control

8.5.1 The Inspection Motion Subsystem and Rotation Subsystem shall provide for 100% geometric inspection coverage of the energetic item in each of the two modes.

8.5.2 The Inspection Motion Subsystem shall provide alignment of the X-ray head and the flat panel detector (FPD).

8.5.3 The Inspection Motion Subsystem shall provide automatic positioning in each of the two operating modes.

8.5.4 The Inspection Motion Subsystem shall have controls to provide manual positioning in DDA or CT mode using the software and variable speed joysticks.

8.5.5 The Inspection Motion Subsystem shall be integrated with the image acquisition system to provide for automatic data acquisition of required images in each of the two modes.

8.5.6 The DR motion control mode shall provide a system administrator determined scan plan of azimuth and elevation in an automated image acquisition mode.

8.5.7 The DR motion control mode shall provide for image acquisition at any operator determined position of azimuth and elevation.

8.5.8 The CT motion control mode shall provide for automated execution of a scan plan determined by the system administrator with input including elevation, number of azimuths for image acquisition.

8.5.9 The CT motion control mode shall provide for CT data acquisition at any elevation determined by the operator.

8.6 Turntables

8.6.1 Three turntables shall be provided to allow for the simultaneous inspection of three samples of item #1 and item #3.

8.6.2 The center turntable shall be rated for items up to 85 lbs.

8.6.3 The other two turntables shall be rated for items up to 20 lbs.

8.6.4 The three turntables may rotate together from a single drive system and may use a single positional feedback system. Individual drive and individual positional feedback is allowed.

8.7 The three turntables shall have an automatic loading ability so that the items can be easily loaded and unloaded from the door opening without having to lean into the cabinet.

8.8 Computer Hardware

8.8.1 In addition to the specific hardware requirements below, computer hardware shall be sufficient to perform CT reconstructions and automatic defect recognition on a single workstation at the cycle times specified in Section 7. This will require the use of multiple Graphic Processing Units (GPUs).

8.8.2 Processor: A minimum of two Intel® Xeon® Gold 6130 Processors (2.1 GHz, up to 3.7 GHz w/Turbo Boost, 22 MB cache, 2666MHz, 16 core processor or better) for the acquisition, the reconstruction and the reviewing computer.

8.8.3 Video:A minimum of two NVIDIA® Quadro® P6000 (24 GB GDDR5X, 4 x Displayport 1.4 + DVI-D DL) High-end NVIDIA® or AMD/ATI™-based graphics card(s) or better for each of the acquisition, the reconstruction and the reviewing computers.

8.8.4 Each of the three computers shall have two Blu-ray disk drives with the capability to burn Blu-ray, DVD and CD disks.

8.8.5 Each of the three computers shall have a medical grade Eizo RX440 monitor, four megapixel, with 10-bit grayscale display capability, compliant with DICOM Part 14, containing a backlight brightness sensor and automatically adjusts brightness.

8.8.6 Each acquisition, viewing & reviewing station shall also contain an additional 30-inch class IPS monitor with the following characteristics:

8.8.6.1 A resolution of 2560x1600 pixels or better.

8.8.6.2 Minimum of 1000:1 true(static) contrast ratio

8.8.6.3 Minimum of 60 Hz vertical refresh rate at full resolution

8.8.6.4 Brightness a minimum of 350 cd/m^2 (candelas per meter squared)

8.8.7 Viewing & reviewing image display shall meet all requirements of ASTM E2698 section 14.2.8. System must be capable of displaying a full screen test pattern in accordance with SMPTE RP 133 (or equivalent) to allow performance of those tests.

8.8.8 Memory: The contractor shall provide a minimum of 384 GB per computer, with additional 384 GB capacity available without replacing installed memory.

8.8.9 Storage: The contractor shall provide a minimum of 16 terabyte (TB) of effective usable data storage space per workstation, in a minimum data protection standard of Redundant Array of Independent Disks 1 (RAID 1 - Mirroring) or better. The reconstruction computer must provide a NAS system configured in RAID 6 capable of accepting 24 drives and contain an initial set of 12 drives with at least 8 TB of storage each.

8.8.10 Operating System: Required operating system is Windows 10 Pro 64-bit, licensed and activated without further online activity required to maintain working status.

8.8.11 Login: A smart card reader shall be provided with each individual computer, with its interface drivers installed.

8.8.12 Human Interface: The contractor shall provide at a minimum a wired 101-key, enhanced keyboard and wired 3-button optical (e.g. laser) scroll mouse with every workstation.

8.8.13 Networking: Each of the three computers shall have a minimum of one free Gigabit Ethernet port after installation. All Ethernet cabling shall be Category 6 (CAT-6) standard or higher performance.

8.8.14 Networking: Each of the three computers shall have a Intel® X710-DA2 10GbE SFP+ Dual Port or better NIC

8.8.15 The contractor shall not install any Wi-Fi® or other wireless communication hardware or modem on any components of the radiographic inspection system. Hardware or software disabling of these types of devices is not acceptable. The contractor shall certify that no Wi-Fi®, 802.11 or other wireless communication hardware or modems are installed on any components of the radiographic inspection system.

8.8.16 Security: System shall include a Trusted Platform Module (TPM) version 1.2 or higher.

8.9 Software

8.9.1 The radiographic inspection system shall have capability and software tools to automate all tests, and to execute analysis of images to generate reports conforming to ASTM E2737, ASTM E2597, ASTM E1695 and other relevant standards.

8.9.2 The radiographic inspection system shall have the ability to record a corrected live view.

8.9.3 The radiographic inspection system shall have the capability to execute diagnostics of its motion control system performance.

8.9.4 The radiographic inspection system shall have the capability to perform diagnostics of its computer hardware.

8.9.5 The radiographic inspection system shall have capability to perform diagnostics on reconstruction software.

8.9.6 The Operator Station system controls shall have at least two levels of password protected access for a “system administrator” and “operator” which are independent of the operating system. The Operator Station shall include a data acquisition computer and a second computer for CT reconstruction and data viewing.

8.9.7 Perpetual licensing shall be provided on all software.

8.9.8 Software shall not require subscription to remain active.

8.9.9 Software shall not require a network connection to operate or maintain.

8.9.10 The contractor shall provide original installation media with license documentation for the computer operating system as well as every software installed application for each computer.

8.9.11 The contractor shall provide software back-up images on separate identical disk drives of all boot drives and other drives containing software as configured at the time of installation.

8.9.12 The contractor shall configure the software on the acquisition, reconstruction and reviewing computers so that the computers will be interchangeable.

8.9.13 The software shall control all appropriate X-ray source parameters, manipulator positioning, and detector settings.

8.9.14 The software shall allow an operator to restore the settings from a previous inspection and automatically move all motion controls in the appropriate location to duplicate the selected x-ray job.

8.9.15 The data acquisition software shall store the DR and RTR data images in a well-defined, documented, non-compressed (or loss-less compression), non-proprietary format conforming to ASTM E2699-11 Standard Practice for (DICONDE) for Digital Radiographic (DR) Test Methods to the following minimal compliance and shall store the CT data images in a well-defined, documented, non-compressed, non-proprietary format conforming to ASTM E2767-11 Standard Practice for (DICONDE) for Computed Tomography (CT) Test Methods:

8.9.16 Original (raw) image without any image enhancements shall be retained. The original data shall be capable of being re-processed and re-displayed using the same or other process algorithm without having to take another radiographic exposure.

8.9.17 The system shall have the capability to save digital images acquired to a DICONDE DVD that can be read by a workstation running GE Rhythm Review software by DICONDE import. The received images shall contain all metadata and shall retain all image resolution and information.

8.9.18 The system shall be set up to easily locate radiographic data by the following parameters at a minimum:

8.9.18.1 Inspection Date

8.9.18.2 Item Name

8.9.18.3 Lot Number

8.9.18.4 Serial Number

8.9.19 VGStudio MAX 3.1 – The vendor shall include software and 3 licenses for VGStudio MAX 3.1, or newer version, as a bundled package consisting of:

8.9.19.1 Coordinate Measuring Tool (64 bit)

8.9.19.2 Nominal/Actual Comparison (64 bit)

8.9.19.3 Defect/porosity Analysis (64 bit)

8.9.19.4 Wall thickness analysis (64 bit)

8.9.19.5 CAD Import with PMI (64 bit)

8.9.19.6 CT Reconstruction (64 bit)

8.9.20 The contractor shall provide software with standard image processing techniques such as gain, contrast, filtering, and thresholding.

8.9.21 The contractor shall provide software with standard image manipulation techniques which include pan, scroll, and zoom.

8.9.22 The contractor shall provide software with standard algebraic manipulation of images.

8.9.23 The contractor shall provide software that has visualization, segmentation, image processing, and data import and export capabilities. The system can export images in 16-bit TIFF format (raw and enhanced images) , JPG format (enhanced images), a suitable video format for live video and a suitable format for importing data in VG Studios.

8.9.24 The contractor shall provide data analysis and measurement software, which shall include statistical image analysis, histogram, and measurement tools for distance, angle, and surface.

9.0 AUTOMATIC DEFECT RECOGNITION (ADR)

9.1 The system shall include automatic defect recognition that is capable of detecting all rejectable defects for Item #1 covered in Section 5.1.5

9.2 This automatic defect recognition shall analyze the reconstructed CT volume. It shall automatically notify the operator when a rejectable defect is present. If a rejectable defect is present in a grain, the software shall show the operator the location of the defect and the size of the defect.

9.3 The ADR functionality shall not call for rejection of an acceptable grain more than 5% of the time. The ADR functionality shall not accept a rejectable grain more than 1% of the time.

9.4 The ADR functionality of the software is required to be operational within 12 months of the delivery of the system or after a minimum of 5000 grains have been run through the system; whichever happens later.

10.0 REPORTING REQUIREMENTS

The contractor shall prepare monthly reports to include written materials and actively participate in the following:

10.1 The contractor shall participate in a post award kick-off meeting to be held within 3 weeks after purchase order placement at IHEODTD in Indian Head MD.

10.2 The contractor shall prepare a monthly report to include a detailed project schedule which shall be updated monthly and be provided in the monthly report indicating the status of all major activities (CDRL A001). The initial schedule shall be presented at the kick-off meeting.

10.3 The contractor shall host a bi-weekly telephone conference call reviewing the progress to date and maintain a list of action items.

10.4 The contractor shall hold a Preliminary Design Review (PDR) meeting at IHEODTD in accordance with the project schedule. The contractor shall provide preliminary design information showing compliance to all specification requirements at least one week in advance of the Preliminary Design Review (CDRL A002).

10.5 Upon successful demonstration of preliminary design compliance to all requirements, authorization to proceed to final design will be given.

10.6 The contractor shall hold a Critical Design Review (CDR) meeting at IHEODTD in accordance with the project schedule. The contractor shall provide final design information showing compliance to all requirements at least one week in advance of the Critical Design Review (CDR) meeting (CDRL A003).

10.7 The contractor shall prepare an Acceptance Test Plan (ATP) to assure that the radiographic inspection system design complies with each and every specification requirement and shall present the ATP at the CDR meeting (CDRL A004).

10.8 Authorization to proceed with manufacture will be provided by IHEODTD following the CDR upon demonstrating that all requirements in this specification will be met with the documented design and that the ATP is acceptable.

10.9 After fabrication of the radiographic inspection system, the contractor shall demonstrate system compliance through execution of the Pre-Delivery Test at the factory. All discrepancies with Pre-Delivery Test compliance will be documented and mitigated prior to repeating the Pre-Delivery Test. Pre-Delivery Test must be passed prior to shipment of the system.

10.10 After installation of the radiographic inspection system at IHEODTD the contractor shall demonstrate system compliance through execution of the ATP at IHEODTD. All discrepancies with ATP compliance will be documented and mitigated prior to system acceptance.

11.0 Pre-Delivery Test

11.1 Pre-Delivery Test Articles

11.1.1 The Pre-Delivery Test will be conducted using a minimum of 6 inert simulated items matching the physical dimensions of Energetic Item 1 and have similar density. At least one inert will be provided of energetic items 2 through 6.

11.1.2 Each simulated item may contain one or more features shown in Figure 3. Some simulated items may contain features which are greater than 0.030” in size but are smaller than the 0.085” size to be considered rejectable. Some simulated items may contain no features. Some simulated items will contain rejectable features in accordance with Section 5.

11.2 Pre-Delivery Test Personnel

11.2.1 During the Pre-Delivery Test, the control console (including all computers) will be operated by a two operators. No other personnel may assist the control station operators during the test.

11.2.2 During the Pre-Delivery Test, the items will be loaded and unloaded into the cabinet by a single operator. No other personnel may assist the loader during the test.

11.3 Pre-Delivery Test Procedure

11.3.1 The Pre-Delivery Test will be conducted with the system starting in a powered down state. All systems, including computers, will start with the power off. The test will run for 3.5 hours, starting from when the control console operator starts turning the power on to start the system. Prior to running the Pre-Delivery Test, the x-ray system should have had a long warm-up within the past several days. The Pre-Delivery Test must include an approximately 15 minute short warm-up for the x-ray system.

11.3.2 The control console operator and loader shall perform all steps associated with starting up the system at the beginning of the work day and then start running the inspection on the simulated grains. Inspection of the simulated grains will continue for the remainder of the test time. Since the number of simulated grains will be limited, each simulated grain will be inspected multiple times. During the test, each simulated grain must be removed from a cart or holding rack, inspected by the system, and then returned to a cart or holding rack. Only after being returned to the cart or rack can the same simulated grain be re-inspected by the system.

11.4 Pre-Delivery Test Result

11.4.1 At the end of the 3.5 hours of the Pre-Delivery Test, the system must have inspected a minimum of 100 simulated grains. To consider a grain to be inspected, the data must be acquired, the volume must have been reconstructed and the operator must have viewed the data and determined whether a rejectable condition was present.

11.4.2 In order to pass the Pre-Delivery Test, all defect features must be clearly discernable in the reconstructed data for all simulated grains scanned during the test. Additionally, the operators must have made the correct determination of whether each simulated grain was acceptable or rejectable in accordance with the criteria. If a defect feature is located that is between 0.06” and 0.10” in its largest dimension, the operator must take a measurement using the system software and this measurement must be within 0.015” of the actual size.

11.4.3 Any issue that requires restarting the software or rebooting the computer is cause for failure of the Pre-Delivery Test.

11.5 Pre-Delivery System Compliance Check

11.5.1 Prior to delivery of the system, a checklist will be used to verify that the system meets all requirements of the contract. Deficiencies shall be corrected prior to shipment of the system.

12.0 Performance Acceptance Test

12.1 Performance Acceptance Test Articles

12.1.1 The Performance Acceptance Test will be conducted using actual samples of Energetic Item 1.

12.1.2 Each sample may contain one or more rejectable features listed in Section 5. Some samples may contain features which are greater than 0.030” in size but are smaller than the 0.085” size to be considered rejectable. Some samples contain no detectable indications. Some samples will contain rejectable features in accordance with Section 5.

12.2 Performance Acceptance Test Personnel

12.2.1 During the Performance Acceptance Test, the control console (including all computers) will be operated by a two operators. No other personnel may assist the control station operators during the test.

12.2.2 During the Performance Acceptance Test, the items will be loaded and unloaded into the cabinet by a single operator. No other personnel may assist the loader during the test.

12.3 Performance Acceptance Test Procedure

12.3.1 The Performance Acceptance Test will be conducted with the system starting in a powered down state. All systems, including computers, will start with the power off. The test will run for 4.5 hours, starting from when the control console operator starts turning the power on to start the system. Prior to running the Performance Acceptance Test, the x-ray system should have had a long warm-up within the past several days. The Performance Acceptance Test must include an approximately 15 minute short warm-up for the x-ray system.

12.3.2 The control console operator and loader shall perform all steps associated with starting up the system at the beginning of the work day and then start running the inspection on the live samples. Inspection of the live samples will continue for the remainder of the test time. During the test, each live sample must be removed from a cart or holding rack, inspected by the system, and then returned to a cart or holding rack. If a rejectable defect is found, the reject must be segregated onto a separate cart or holding rack.

12.4 Performance Acceptance Test Result

12.4.1 At the end of the 4.5 hours of the Performance Acceptance Test, the system must have inspected a minimum of 130 samples. To consider an item to be inspected, the data must be acquired, the volume must have been reconstructed, the operators must have viewed the data and determined whether a rejectable condition was present, and the item must have been placed on the correct cart or holding rack.

12.4.2 In order to pass the Performance Acceptance Test, all defect features greater than 0.030” in size must be clearly discernable in the reconstructed data for all samples scanned during the test. Additionally, the operators must have made the correct determination of whether each sample was acceptable or rejectable in accordance with the criteria. If a defect feature is located that is between 0.06” and 0.10” in its largest dimension, the operators must take a measurement using the system software and this measurement must be within 0.015” of the actual size.

12.4.3 Any issue that requires restarting the software or rebooting the computer is cause for failure of the Performance Acceptance Test.

13.0 Documentation Deliverables

13.1 Certification of compliance with 21CFFR1020.40 (CDRL A005).

13.2 Labeling of radiographic inspection system compliant to 21CFR1010.2 and 21CFR1010.3. (CDRL A006)

13.3 Copy of letter of accession from the FDA indicating receipt of certification documentation (CDRL A007).

13.4 All materials submitted to the FDA supporting compliance with 21CFR1012.40 (CDRL A007).

13.5 Preliminary Design Review (PDR) documentation (CDRL A002)

13.6 Critical Design Review (CDR) documentation (CDRL A003)

13.7 Acceptance Test Plan (CDRL A004)

13.8 Design Drawings to include complete detailed mechanical, electrical, software, and other documentation (CDRL A008)

13.9 Facilities interface document (CDRL A009)

13.10 All software licenses (CDRL A009)

13.11 Copies of training material, operating manuals, technical manuals (CDRL A009)

13.12 List of recommended spare parts (CDRL A009)

13.13 Preventative Maintenance Plan (CDRL A009)

14.0 COMPUTER BACKUP DELIVERABLES

14.1 Original software distribution and copies of original software distribution

14.2 Hard disk drives that contain mirrored backup of the installed disk drives and shall be identical to the installed disk drives.

15.0 TRAINING REQUIREMENTS

15.1 Digital Radiography and CT Training

The contractor will provide a 40-hour training class meeting the recommended curriculums from FWG-IDR and MAI to up to six (6) system operators. This training can be at the contractor site, NSWC IHEODTD or a third-party.

15.2 OPERATIONS TRAINING

Following successful completion of the Performance Acceptance Test, the contractor shall provide training on all aspects of normal operation, calibration and required daily maintenance to up to six (6) system operators.

15.3 MAINTENANCE TRAINING

Following successful completion of the Performance Acceptance Test, the contractor shall provide maintenance training on all, required maintenance, recommended maintenance, and routine maintenance to up to six (6) system operators.

16.0 TOOLING DELIVERABLES

Upon completion of the Performance Acceptance Test, the contractor shall deliver all tooling required for:

16.1 Operation of the radiographic inspection system.

16.2 Maintenance of the radiographic inspection system.

17.0 WARRANTY

The contractor shall provide a full onsite parts and labor warranty for the entire system of a minimum of 12 months from date of acceptance.

18.0 SPARE PARTS

The contractor shall provide any recommended consumable and spare parts that are likely to be used in the initial 2 years of operation.

19.0 PRESERVATION, PACKING, AND SHIPPING

19.1 The contractor shall utilize standard methods for preservation and packaging appropriate for the components and acceptable to commercial carriers. As a minimum, all items susceptible to damage from exposure to the elements shall be preserved and/or packed to prevent damage. The contractor shall be responsible for ensuring that the equipment is delivered to IHEODTD in good condition.

19.2 The EPRIS shall be shipped FOB Destination, IHEODTD. All costs associated with shipping shall be included in the proposal price.

19.3 Delivery shall be made during normal operating hours of the receiving activity and location shall be determined by IHEODTD.

20.0 INSTALLATION AND MAINTENANCE REQUIREMENTS

20.1 The contractor shall provide all parts, labor, fabrication and installation of the radiographic inspection system and any associated equipment.

20.2 All moving equipment required for installation shall be brought by the contractor.

20.3 The contractor shall make no modifications to the building (holes in walls, flooring trenches, etc.)

20.4 The contractor shall use US citizens to install, place the equipment in operation and train personnel.

20.5 The contractor shall not plan on IHEODTD for assistance for installation, diagnosis, troubleshooting, or repair’s during the installation, activation, testing, and training.

20.6 No maintenance shall require lifting devices.

20.7 All Maintenance shall be performed with no more than 2 people using only hand tools.

21.0 SECURITY, SAFETY, AND FIRE PREVENTION

21.1 The contractor shall abide by all Navy and IHEODTD security requirements.

21.2 The contractor shall abide by all Navy and IHEODTD safety requirements.

21.3 The contractor shall abide by all Navy and IHEODTD fire prevention requirements.

22.0 INSTALLATION REQUIREMENTS

22.1 Safety permits must be obtained in advance for all work requiring safety permit approval.

22.2 IHEODTD shall provide access to the necessary areas for installation of radiographic inspection system by the contractor.

22.3 IHEODTD shall be responsible for relocating agreed upon obstructions identified by the contractor during the kickoff meeting and facilities interface document provided by the contractor.

22.4 No Government materials or equipment shall be removed from IHEODTD by the contractor. All packing, packaging, and scrap metal accumulated during the performance of the contract shall be removed and disposed of properly off site by the contractor.

22.5 It shall be the responsibility of the contractor to verify all measurements, locations of structures and utilities, and any other physical conditions which would affect the progress or quantity of work. The contractor shall provide IHEODTD with a comprehensive list of all utilities that may require modification in the Facilities Interface Document.

22.6 IHEODTD will not provide engineering support for the design of the system. If any deviations are required from the statement of work or salient features the contractor must submit a request for deviation. All deviations must be reviewed and approved by IHEODTD prior to implementation.

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