D-794
Use and Calibration of an Analog Brix Meter
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1.0 Purpose
This procedure provides instructions on the use and calibration of Analogue Brix meters in the
QC Laboratory and production.
2.0 Scope
This procedure applies to all dietary supplement, pet product, cosmetic, and pharmaceutical
raw materials and finished products used or manufactured at Jon Labs that require Brix testing.
3.0 Responsibility
3,1 It is the responsibility of Production and QC Laboratory personnel to follow this
procedure.
3.2 It is the responsibility of QC Laboratory and Production Management to implement this
procedure and to ensure that the procedure is being followed.
3.3 It is the responsibility of QC Laboratory Management to keep this procedure aligned
with current practices,
4.0 Definitions
4.1 Brix Refractometer — an instrument for measuring the % Brix of materials using the
refractive index or other methods
42 Degrees Brix (°Bx) — (of a material/substance) is a common method for measuring
dissolved solids in a solution. It is routinely used to measure the % weight of sugar in
aqueous solutions. Each °Bx is equivalent to 1g sugar per 100g of solution
[SOP
Standard Operating Procedure SOP No Rey
Use and Calibration of Analog Brix Meter D-794 Page 2 of 5
4.3. IPA-- Isopropyl alcohol
44 QC~- Quality Control
4,5 PQV— Process Quality Verification
5.0 References
Instruction manual, Cole-Parmer “Handheld Analog Refractometers”
5.4 5.2 G-201, SOP, Calibration Program
5.3 D-794-1F, Form, Brix% Test Ticket
5.4 D-794-F2, Form, Refractometer Daily Calibration Log
A-106, SOP, Documentation Guidelines for cGMP Records
5.5 C-502, SOP, Record Storage, Retention, and Destruction
5.6 6.0 Procedure
[SOP
Standard Operating Procedure SOP No Rev
Use and Calibration of Analog Brix Meter D-794 1 | Page 3 of5
Description
1) Prism
2) Cover plate
3) Calibration screw
4) Mirror tube
4) Eyepiece (adjusting ring of diopter}
6.1 General
6.1.1. The refractometer should only be read while in a horizontal position.
6.1.2 The front end should be held in the direction of a bright light. Preferably
incandescent or natural light.
6.1.3 The eyepiece can be adjusted until the reticle can be seen clearly.
6.1.4 The rubber cover on the calibration screw (3) should be kept covered when not
being serviced to keep liquid from entering the refractometer.
6.2 Cleaning
6.2.1 The prism (1) and cover plate (2) should be cleaned before and after each use
with a clean, soft cloth or paper. IPA can be used to help facilitate the removal
of oils or poorly soluble solids on the prism or cover plate.
6.2.2 The refractometer should be dried thoroughly before storage and use.
6.3 Calibration
6.3.1 The refractometer should be calibrated daily with extra-virgin olive oil. Olive oil
should have a °Bx or Brix% value of 71-72.
6.3.1.1 Using a pipet put about 2-3 drops of olive oil on a clean, dry prism
surface.
[SOP
Standard Operating Procedure SOP No | Rev
D-794 1 Page 4 of 5
Use and Calibration of Analog Brix Meter
6.3.1.2 The cover plate should be placed on top of the prism. If bubbles are
observed, press lightly on the cover plate to remove them.
6.3.1.3 Holding the refractometer horizontally, look though the eyepiece.
There should be a distinct separation between white and blue sections.
The line where these sections meet is called the contrast line.
6.3.1.4 If reading is not between 71 and 72, remove calibration screw cover
and using an appropriate flat screwdriver, turn the screw (3), clockwise
or counterclockwise until the contrast line is approximately 71.5
Brix%.
6.3.1.5 Return the calibration screw cover and notate that the refractometer
was calibrated,
6.3.1.6 Clean and dry the prism and cover plate.
6.3.2 Record the calibration activities on Form D-794-F2 Refractometer Daily
Calibration Log.
6.4 Usage
Brix measurements are generally performed at 20°C and is dependent on
6.4.1 temperature, however, values for analogue brix measurements are currently for
empirical purposes only and were developed at the temperature listed in the
specific profile.
To aclean dry prism, add a few drops of sample and cover with the cover plate.
6.4.2
6.4.3
Hold horizontally and read the value where the contrast line lies (example
shown below).
[SOP
Standard Operating Procedure SOP No Rev
Page 5 of 5
Use and Calibration of Analog Brix Meter D-794
6.4.4 Record value on Form D-794-F1 Brix% Test Ticket.
6.5 Documentation Requirements
A POV check must be performed for each completed logbook page as outlined
6.5.1 in SOP A-106 Documentation Guidelines for cGMP Records.
Documents will be maintained following SOP C-502 Record Storage, Retention,
6.5.2 and Destruction.
7.0 Revision History
| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 02/10/20 | New. i 04/15/23 Updated logo and format. Revised responsibilities, CC-23-0186 K. Burris | - | - |
[SOP
IAN LABS Brix % Test Ticket
Form: D-794-F! CCRNo. CC-23-0186 Revision: 1
Sample Prep
Sample Name:
Sample Batch /R Number:
Sample SKU /RMID
Test Date:
Equipment
Refractometer Ion ID #:
Calibration Results: C] pass (1 Fail
Temperature (°C):
Thermometer Ion ID #:
Last Calibration Date:
Data / Parameters
Brix %:
Specification
Determination (circle one): Pass Fail
Comments:
Performed By/Date:
Reviewed By/Date:
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