A06_Specifications.docx

SALIENT CHARACTERISTICS for NMTL (BLM Lab) particle analyzer

(Particle Analyzer) must be a Dynamic Image Analyzer for particle shape and size analysis or equivalent:

Must be:

1. An automatic, fully independent, stand-alone apparatus for measuring the shape and size of particles by dynamic image analysis in real-time flow.

· Particle size range should be 1-300 µm.

2. Possibility/ability to/of updating the optical system in order to extend the particle measurement range by 10-800 µm, 100-2500 µm by replacing the optical system.

3. The device can be integrated with any type of particle size flow analyzer currently in use, if there is a need.

4. The multi-functional and flexible design of the apparatus will allow for recirculation, single-pass measurement, or material line measurement.

· The apparatus will/must be compatible with a wide range of solvents.

5. Apparatus should be equipped with an internal peristaltic pumping system with chemically resistant tubing throughout the fluid path.

· Possible measurements at different flow rates for fluids of different viscosities.

6. System must be capable to run dry samples using dry dispersion.

7. The device is equipped with a high-speed digital camera, capable of at least 127 frames per second and resolution up to 5 Mp.

· The device will be equipped with telecentric optics to minimize particle rejection (according to the ISO13322-2 standard), which enables real-time analysis at very high speeds.

· Camera is field interchangeable and upgradable by the end user.

8. The device has interchangeable and disposable wet and dry flow cell cartridges.

9. All analyzed particles are saved as thumbnail images.

10 – System capable of reporting particle count and concentration of whole sample or select particles in a sample.

11 – System will allow for re-analysis of samples by saving raw image data.

12. The instrument records more than 30 shape parameters, displayed as real-time data captured during particle analysis.

The user can use several shape measures to classify the particles:

- Circle models

• Perimeter circularity

• Equivalent circular area diameter

• Equivalent circular perimeter diameter

• Bounding circle diameter

• Mean radius diameter

• Circularity

• Smoothness

• Compactness

- Ellipse models

• Equivalent elliptical area, width, length

• Bounding ellipse width, length

• Elliptical aspect ratio

• Ellipticity

- Rectangle models •Bounding rectangle length, width

• Bounding rectangle aspect ratio

• Rectangularity

- Polygonal models

• Polygon order

• Interior angle

• Convexity

- Fiber models

• Fiber length, width

• Fiber aspect ratio

• Fiber curl

- Irregular models

• Feret length, width

• Feret aspect ratio

• Surface uniformity

- Pixel intensity

• Opacity

• White fractions

13. The device software will be able to compare different analysis using histogram overlays for all analyzed shape parameters.

14. The device is capable of correlating any two shape parameters for a given sample.

15. The device is able to represent data results as Sieve correlation equivalency.

16. The device can perform a three-dimensional (3D) analysis with random orientation of particles in the flow.

17. The device has a particle classification function to allow for automatic analysis of mixed sample components giving percentage of sub-populations of mixed samples.

18. The device is capable of data export to Excel format. Automatic generation of reports of results can be in pdf format.

19. the device performs real-time data backup for remote viewing.

20. The apparatus is compliant with 21CFR Part 11 and with data integrity requirements, if needed for the end user.

Device specification for operation:

21. Working temperature: 10 to 45˚C.

22. Power supply: 100 - 240 VAC, 50 - 60 Hz.

23. Dimensions: (H) 38.1 cm x (W) 25.4 cm x (L) 63.5 cm.

24. Weight: 13.2 kg.