B-215
Digital Caliper Usage and Cleaning
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1.0 Purpose This procedure defines the process for the operation and cleaning of digital calipers used for measuring dimensions. 2.0 Scope This procedure applies to all digital hand-held calipers used for measuring tablet dimensions at Ion Labs, Inc. 3.0 Responsibility 3.1 It is the responsibility of all production and quality personnel who utilize digital calipers to follow this procedure. 3.2 It is the responsibility of department Supervisors/Managers to implement this procedure and to ensure that the procedure is being followed. 4.0 Definitions 4.1 IPA — Isopropyl! Alcohol 42 QC- Quality Control 5.0 References N/A [SOP Standard Operating Procedure SOP No | Rev B-215 4 Page 2 of 3 Digital Caliper Usage and Cleaning 6.0 Procedure 6.1 Caliper Use 6.1.1 Ensure that the calibration of the digital caliper has not expired. If the calibration is expired, the caliper is dropped, or the caliper does not read zero before use, a supervisor must be informed and the calipers removed from service. Do not use the caliper if any of these circumstances are present. 6.12 Ensure that the jaws are clean and free of any dust or powder. 6.1.3 Turn the caliper on. Ensure that the dial or digital screen reads zero. 6.1.4 Ensure that the screen indicates millimeter measurements and not inches. Press the in/mm button to switch from inches to millimeters. 6.1.5 Press the lever on the top of the caliper. This will draw the gauge plunger back. 6.1.6 Place the item to be measured between the plunger and the stationary arm. 6.1.7 Slowly release the plunger until it has touched the item. 6.1.8 Read the measurement and record the data in the appropriate in-process record or test ticket. 6.1.9 Discard the measured item, as applicable. 6.2 Cleaning 6.2.1 Use acloth dampened with water to remove excess powder. 6.2.2 Use a cloth dampened with IPA to wipe down the entire caliper. 6.2.3 Allow the caliper to air dry prior to use. [SOP Standard Operating Procedure SOP No | Rev er Dieg ist al Calie per Usage and Cleania ng B:= itS 4 a :€ rf) 7.0 Revision History | Rev | Date | Description of Changes | CCR # | By | |-----|----------|------------------------|-------|----| | 0 | 08/16/10 | New - l 05/08/13 Updated SOP format and title 13-286 M. Wienke | - | - | | 2 | 01/27/16 | Changed the SOP format, updated the SOP | 15-0934 | K. Burris | | 3 | 01/22/19 | Scheduled review: cleaned up procedure. Clarified step 6.1.1. | 19-0079 | K. Burris | | 4 | 04/14/22 | Scheduled review: changed logo. Updated procedure to remove CC- specificity to tablets. | 22-0157 | K. Burris |