Attachment_3_Testing_Method.docx

Attachment 4 3 – Prototype testing protocolTesting Method

a. Quality Assurance Check: Comment by Le, Van B.: You may wish to describe the desired or expected outcome (or an acceptable range of acceptable results) for each step, akin to a test case, in a table with three columns (left column describes the test steps, center column describes the expected/acceptable results/outcomes, and the right column captures the actual results/outcomes).

Step1: Open A, enter value B, activate button V1 => actual resulting values => values should be within range [n,m], or acceptable outcome is XYZ.

Step2: etc.

This effort will allow you to evaluate the prototype in an neutral way.

Using the check card the device will be subject to the current CDx QA results in the following manner:

Wavelength / Filter (functional arrangement of illumination activation and filter setting (see instructions below)

1. Use of the appropriate filter for UV-VIS imaging and for IR imaging Comment by Batson, JaCinta S.: Agreed. We will keep it general until we complete Tier 1. But we may want to either be more specific about the wavelengths in the SOW or remove the wavelengths in this document. Remember e kept the SOW very general so that we would not give specifics on filters and wavelengths.

2. Under “UV-VIS” image settings the following should be performed and observed:

a. Activate “UV” wavelength

b. Boxes B1 and B2 should not fluoresce

c. Activate “VIS” wavelength

d. Boxes B1 and B2 should fluoresce

3. Under “IR” image settings the following should be performed and observed:

a. Activate “UV” wavelength

b. Box B1 should not fluoresce and box B2 should fluoresce

c. Activate “VIS” wavelength

d. Box B1 should not fluoresce and box B2 should fluoresce

e. Activate “IR” wavelength Comment by Ranieri, Nicola: We need to be sure this wavelength is listed in our SOO etc. Comment by Batson, JaCinta S.: Included

f. Boxes B1 and B2 should not fluoresce and any shades of grayscale value should not be visible

g. Activate “WH” (white light)

h. Box 1 should be dark in grayscale value and B2 should not fluoresce and any shades of grayscale value should not be visible

i. Remove the filter and activate the “WH”

j. Both boxes B1 and B2 should be visible and be dark in grayscale value

4. Measurement of a known authentic and counterfeit dosage form. The following procedures will be performed to evaluate the ease and the speed to conduct a “quick” and an “in-depth” product screen examination

a. Device Setup and prepare for an examination:

i. Plug in the device to a power source

ii. Perform a turn ON and turn OFF the device; test ease of this step

iii. Turn the device back ON and continue the examination

iv. Setup the shade then take down the shade; test the ease and how quickly this operation can be performed

v. Re-setup the shade to continue the examination

b. Focusing the device prior to an examination if manual focus. If auto focus, perform a focus test under all three illumination conditions:

i. Place the device over an item to scan

ii. Perform focus / auto focus operation using white light

iii. Perform focus / auto focus operation using UV-Vis wavelength

iv. Perform focus / auto focus operation using IR wavelength

v. Perform focus operation to continue the examination

c. UV/Vis and IR Scan of finished dosage form (not including package; carton, vial, bottle, etc.):

i. Continue from step B

ii. Perform a selected short scan

iii. Switch to the appropriate filters for UV-Vis and for IR. Preferred method would be to switch filter by software. If filters are placed manually in front of the imaging sensors then place filters to continue the examination.

iv. Activate the wavelength(s) of choice if known; if not, do a Full Scan.

v. Activate the first wavelength to illuminate the product for as long as needed to see its fluorescence or lack of.

vi. Activate each wavelength as long as necessary

vii. Perform a Full Scan using filters:

a. Activate all UV, VIS and IR “UV1” and hold for 10 seconds

d. Capture Photo:

i. Setup an auto alpha-numeric sequential image filename related to the evidence number (sample number), project name, and product being scanned

ii. Adjust the item to capture as preferred

iii. Be sure it is in focus

iv. Place a scale/ruler or a digital scale bar calibrated to the zoom factor

v. Activate and hold the wavelength of illumination desired and capture the photo(s);

vi. Take photos of product under the White light, UV-VIS, and IR

vii. Zoom in and zoom out to preferred image and capture photo

viii. Perform the ease of reviewing an image or images prior to continuing the scan

ix. Move the device around or the product to capture all necessary photos

e. Capture Video:

i. Perform same setup for photos. Take video of product under the White light, UV-VIS, and IR

ii. Review video in between video captures as well after the screen is completed

f. Digital Microscope Scan:

i. Plug in the microscope power cord to an external signal input

ii. Upon connecting the digital microscope to the device the microscope light should come on and an image should display on the monitor

g. Accessing Library of Captured Images and Captured Video

i. Upload an image library to the device or connect the device to a server where the image library of choice is located

ii. Navigate to destination of the image library’s folder(s)

h. Accessing Captured Images and Videos

i. Ease of accessing all photos and videos

i. Measurement of a known authentic and counterfeit package

i. Repeat the same method for packaging while changing out the lens to a wide angle or wide enough to see most of packaging within a short distance image1.jpeg image2.jpeg image3.jpeg image4.jpeg image5.jpeg image6.jpeg image7.jpeg