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QC SOP

SOP Title: Operation, Cleaning and Calibration of Automatic Refractometer

SOP Title: Operation, Cleaning and Calibration of Automatic  Refractometer

 

  1. Objective:

To lay down the procedure for Operation, Cleaning and Calibration of Refractometer.

  1. Scope:

This SOP is applicable for Operation, Cleaning and Calibration of Refractometer located in Quality Control Laboratory.

 

  1. Responsibility:
  • Quality Control: To prepare and review the SOP. To follow the procedures laid down for Operation, Cleaning and Calibration of Refractometer as per this SOP.
  • Quality Assurance Department: To review and approve the SOP and Annexures.

 

  1. Accountability:

Head Quality Control Department, Head Quality Assurance Department.

  1. Procedure

 

5.1 Safety Precautions/Instructions:
5.1.1 Ensure all the electrical connections are properly earthed. Ensure the power plug of the automatic Refractometer is fixed in the socket properly.
5.1.2 Wear personal protective equipments such as safety glasses, hand gloves during operation of instrument.
5.1.3 Ensure that the ON/OFF switch is working properly by switching “ON” the Refractometer.           
5.1.4 Clean the Automatic Refractometer with dry lint free duster.
5.1.5 Do not move the automatic Refractometer during cleaning
5.1.6 Do not attempt to do any repairs unless trained.
5.1.7 Keep measuring surface clean. Clean the measuring surface with a wet (with water or isopropyl alcohol), soft, clean cloth or paper towel. For most accurate reading, keep the measuring surface clean and free of residual at all times.
5.1.8 Use only one or two drops of sample. Use a disposable plastic pipette to place the sample on the measuring surface and use the same pipette to suck back up and dispose of it.
5.1.9 Inspect the measuring surface to make sure it is clean and dry with IPA before putting sample on measuring surface.  
5.1.10 Do not keep instrument to temperature above 50°C
5.1.11 Keep instrument away from vibration.
5.2 Operation  Procedure:
5.2.1 Check the validity of calibration before starting any operations.  
5.2.2  The instrument should be cleaned before operation.
5.2.3
Switch “ON” the mains and switch “ON” Refractometer with on/off switch provided at back side of the instrument. The main screen will display menu as :

1.Escape       2.Menu

3.Zero  4.Print  5.Start

 

Introduction to Key:
5.2.4
Escape-Use to exit the current window to return to  previous.

 

Menu-The menu key will allow user to access parameter as scale,  temperature and setup.

 

Zero-The “zero” is used to perform auto zero of instrument.

 

Print-Print key is used to print measured readings.

 

Start-Start key is used for measurement of sample.

 

5.2.5 Click on “MENU” key on main screen, The system will ask for password. Enter  Password , Then screen will show parameters as :

1. Scale                           2.Temperature                    3.Setup

 

 

 

5.2.6 Click on “SCALE” option from menu  key, the screen will display parameters as :

1. Refractive Index         2. Brix                  3.Honey

 

 

Note: Brix and Honey are scale used generally in food industry.
5.2.7 Click on “Refractive index” parameter, then press “Exit” key.
5.2.8
  1. Temperature Control          2.Temperature Correction

Click on “TEMPERATURE” parameter, the screen will display sub-parameter

5.2.9 Click on “TEMPERATURE CONTROL” option, the screen will display options as

1. Temperature Control 20ºC           2. Temperature Control 25ºC

3. Temperature Control Off

 

5.2.10 Select “Temperature control “20ºC or 25ºC” as per standard test procedure and click on “back” option  
5.2.11 Click on “TEMPERATURE CORRECTION” from temperature parameter ,  and press “back” key.
5.2.12 Click on “SETUP” menu from main screen “menu” key .   The Screen will display setup parameters as

1.User calibration   2.Operational parameters      3.Measurement Parameters

4.Communication setting   5.system information        6.Service calibration

Introduction to key:  
5.2.13
Service calibration

This setup menu is used by outside service                                 engineer during annual maintenance.

System information

 

It contains the instrument information.

Communication setting

 

It shows setting to print the results.

5.2.14
Click on “OPERATIONAL PARAMETER” setup menu , The screen will display option as

1. Temperature  scale     2.Time/Date  3.Keylock                    4.Password             5.Precision

 

5.2.15
Click on “Temperature scale” option. The screen will display scale option as

1. Celsius        2. Fahrenheit scale

 

5.2.16 Select “Celsius” temperature scale and press “Exit” key.
5.2.17
Click on “MEASUREMENT PARAMETERS” from “Setup” menu. The screen will display parameter as

1.Measurement Mode     2.Stability Criteria       3.Sound

 

5.2.18
Click on “Measurement Mode” parameter. The screen will display the mode as

1. Load & Go        2. Single Measure

 

 
Introduction to Key :
5.2.19
Load & Go- This Mode automatically measure the sample and continue measuring the sample until it has been removed.

 

  

Single Measure- This Mode measure the sample 1 time after the sample is placed on the prism and has meet the criteria for temperature and stability.

 

 “Single measure” Mode is used in routine analysis.

5.2.20 Click on “Single Measure” mode. Press on “Done” key.
5.2.21 Click “zero” key on main screen to auto zero the instrument without blank sample i.e. Air Zero. Then the system will display a message “Place pure water on sample dish. Then press zero again.”    
5.2.22 Place approximately 1-2 drop of water as blank on measuring surface, such that black circle of measuring surface will cover. Put the lid of Refractometer on sample. Click on “ZERO” Key on main screen to auto zero.
5.2.23 After pressing “ZERO” key, the system will show the message of “Water Zero successful”  
5.2.24 Click on “Continue” option. Then system will start to measure Refractive index of water. The measured reading will display on main screen.
5.2.25 Clean measuring surface with paper towel or cloth.  
5.2.26 Place sample on measuring surface and put the lid of Refractometer.
NOTE: Place approximately 1-2 drop of sample or blank such that it should cover black circle of measuring surface. If sample is not sufficient on measuring surface, the system will display a message “Waiting for Sample”
5.2.27 Click on “START” Key on main screen. The measurement reading will display on main screen.
5.2.28 Click on “PRINT” key on main screen. The print taken via RS 232 Port cable which is connected to printer  OR  via  PC connected to Printer.  
5.2.29 After measurement clean the measuring surface with wet cloth or paper towel of water or isopropyl alcohol to remove residue particle.  
5.3 Calibration procedure :
5.3.1 Update the “Instrument/Equipment Usage Log Book” as per SOP “Calibration of Instruments and Equipments”.
  Frequency:  Quarterly or after carrying out any major maintenance work.  
5.3.2 Generate the A. R. No. on the “Instrument/Equipment Calibration Register” as per SOP and give requisition to QA department for calibration formats of instruments on the due date of calibration.
5.3.3 For issuance of calibration report refer SOP “Control of documents, Preparation, Approval, Issuance and Maintenance.  
5.3.4 Perform the calibration of instrument as per Annexure and procedure mentioned below.  
5.3.5 Determine the refractive index of the following standard materials:

1)     Purified  Water at 20°C

2)     Carbon tetrachloride

3)     Toluene

 
User Calibration: (Two Point Calibration)
5.3.6 Click on “User Calibration” setup parameter from “Setup” option.  The screen will show sentence

Prism must be cleaned and covered” then click on “Continue” key.

5.3.7 After clicking  on “continue” option

Wait for air zero as shown in figure.

5.3.8 After completion of  air zero, the screen will display parameter as

 

1. Refractive index        2. Brix

5.3.9 Click on “Refractive index” option. The screen will

Display message  as “ Place sample 1 on prism”

“Water” is used as sample 1

5.3.10 Click on “Done” key. The screen prompt enter Standard value of Sample 1

E.g. Water –   1.33299

5.3.11 Press “Enter” hence system will start measuring sample-1.
5.3.12 After completion measurement of  sample-1 The system will then proceed  sampe-2 Remove sample -1 from measuring surface.

Clean it wet cloth or paper towel so that no any Residue obtained.

5.3.13 Place “sample-2” on measuring surface .
5.3.14 Press “Enter” hence system will start measuring sample-2

After measuring sample-2 the system will return to main screen.

5.3.15 Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria. If instrument fails to meet to acceptance criteria then file an incident and investigate the cause of failure.
5.3.16 Update the “Instrument/Equipment Usage Log Book”, “Annual Calibration Schedule” and “Quarterly Calibration Schedule” as per SOP  “Calibration of Instruments and Equipments”.
5.3.17 Affix the “Calibration Status Label” on the Instrument as per SOP “Calibration of Instruments and Equipments”.
5.3.18 If calibration activity is outsourced, the values are to be transcribed in the Annexure , and external party certificate to be attached.

 

  1. Definitions / Abbreviations:

Definitions:

  • Calibration: Tests performed to ensure that the instrument is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
  • Refractometer: Automatic Refractometer automatically measure the refractive index of a sample. The automatic measurement of the refractive index of the sample is based on the determination of the critical angle of total reflection.

 

Abbreviations:

Abbreviation Expansion
SOP Standard Operating Procedure
QC Quality Control
QA Quality Assurance
0C Degree Celsius
No. Number

 

                                          Calibration Report

Sr. No. Standards Acceptance Criteria    Observed Values
1. Purified Water at 20°C  Water     at 20°C ±0.5°C

 

1.33299  (±0.0001) (1.3329  to 1.3331)

2. Carbon Tetrachloride at 20°C  Carbon Tetrachloride at 20°C±0.5°C

1.4603 (±0.0003)   (1.4600  to  1.4606 )

3. Toluene at 20°C Toluene at 20°C ±0.5°C

1.4969    (±0.0003)  (1.4966  to 1.4972)

 

   Remark: The result Complies/Does not complies as per acceptance criteria.

 

Performed By: ________________     Date:________________       Checked By: ______________           Date: ______________

                                                      

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

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