D-827
Calibration and Use of Brix Refractometers
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1.0 Purpose This procedure provides instructions on the use and calibration of both analog and digital 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 Ion 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 4.2 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 | Rev Calibration and Use of Brix Refractometers D-827 7 4.3. IPA-— Isopropyl alcohol 44 QC- Quality Control 4.5 PQV-— Process Quality Verification 5.0 References 5.1 Instruction manual, Cole-Parmer “Handheld Analog Refractometers” 5.2 G-201, SOP, Calibration Program 5.3 D-827-F1, Form, Brix% Test Ticket 5.4 D-827-F2, Form, Refractometer Daily Calibration Log 5.5 B-911, SOP, Continuous Gummy Manufacturing Process 5.6 B-911-F1, Form, Gummy Inline Equipment Verification Log 5.7 IPRM-G880 In-Line Brix Sensor Instructions 5.8 A-106, SOP, Documentation Guidelines for cGMP Records 39 C-502, SOP, Record Storage, Retention, and Destruction 5.10 C-501, SOP, Document Control Procedure 6.0 Procedure for Analog Brix Meters Description 1) Prism 2) Cover plate 3) Calibration screw 4) Mirror tube 5) Eyepiece (adjusting ring of diopter) [SOP Standard Operating Procedure SOP No | Rev Calibration and Use of Brix Refractometers D-827 2 Page 3 of 6 6.1 General Use for Analog Brix Meters 6.1.1 The refractometer should only be read while in a horizontal position. The front end should be held in the direction of a bright light. Preferably 6.1.2 incandescent or natural light. The eyepiece can be adjusted until the reticle can be seen clearly. The rubber cover on the calibration screw (3) should be kept covered when not 6.1.4 being serviced to keep liquid from entering the refractometer. 6.2 Cleaning The prism (1) and cover plate (2) should be cleaned before and after each use 6.2.1 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 BrixTM% 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. 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. [SOP Standard Operating Procedure SOP No Rev Page 4 of 6 Calibration and Use of Brix Refractometers D-827 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-827-F2 Refractometer Daily Calibration Log. 6.4 Usage 6.4.1. Brix measurements are generally performed at 20°C and is dependent on temperature, however, values for analogue brix measurements are currently for empirical purposes only and were developed at the temperature listed in the specific profile. 6.4.2 Toaclean dry prism, add a few drops of sample and cover with the cover plate. 6.4.3. Hold horizontally and read the value where the contrast line lies (example shown below). 6.4.4 Record value on Form D-827-F1 Brix% Test Ticket. [SOP Standard Operating Procedure SOP No | Rev Calibration and Use of Brix Refractometers D-827 2 Page 5 of6 6.5 Documentation Requirements 6.5.1 A PQV check must be performed for each completed logbook page as outlined in SOP A-106 Documentation Guidelines for cGMP Records. 6.5.2 Documents will be maintained following SOP C-502 Record Storage, Retention, and Destruction and C-501 Document Control Procedure. 7.0 Calibration Verification of Inline Brix Meters used in Gummy Production 7.1 This procedure applies only to inline Brix meters used in gummy production. It does not apply to handheld or manual models. This procedure must be performed on each brix meter at least once monthly. 7.2 Materials Needed 7.2.1 Deionized water 7.2.2 Inline Brix Meter 7.2.3 Brix Meter verification housing 7.3 Procedure 7.3.1 While the equipment is not in operation, disassemble the Brix meter from its housing by removing the clamp union. Keep in mind: there may be residual fluid that escapes while removing the meter- this is normal. Next remove the Brix meter, then remove the gasket. 7.3.2 Inspect the prism on the Brix meter. If there is any debris or crystallization on the prism, gently clean with deionized water and a soft cloth. [SOP ION Brix % Test Ticket Sp sizzvors Form: D-827-F1 CCRNo. CC-23-0515 Revision: 2 Logbook Number: Logbook Page: Sample Prep Sample Name: Sample Batch / R Number: Sample SKU / RMID Test Date: Equipment Refractometer Ion ID #: Calibration Results: C] Pass CL] 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: