OPERATION OF REFRACTOMETER (MAKE – RUDOLPH RESEARCH)

• OBJECTIVE:

• To lay down a procedure for operation of Refractometer, Make – Rudolph Research.

• SCOPE:

This SOP is applicable to the procedure for operation of Refractometer, Make – Rudolph Research at {Company Name} {Location}.

• RESPONSIBILITY:
• Officer/Executive/Designee Quality Control – Shall be responsible for operation as per SOP.
• Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
• ACCOUNTABILITY:

             QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:
  • Check the cleanliness of the work area and instrument.
  • Connect the power cord to the electrical supply source.
  • Switch on the instrument by using the ON/OFF switch present on the backside of the instrument.
  • Lift the presser and clean the sample well by using solvents like water, ethanol, acetone, Iso propyl alcohol.
  • Place the sample to be measured in the sample well, after placing the sample in the sample well, close the presser.
  • Place enough sample so that it touches the inner part of the silver metal ring all the way round.
  • Now press the Temp soft key present on the touch screen, two options are displayed
• Temp Control
• Temp Correct
  • Now press the Temp control soft key and enter the required temperature.
  • Press the Measure key, system prompts for operator password enter the password and press enter.
  • Now press continue the stabilizing temperature message displays.
  • Press Enter manual and enter the Lot ID and press enter.
  • Press Enter manual and enter the sample ID and press enter.
  • The sample Refractive index measurement takes place.
  • Once the scan is complete the results are displayed.
  • Now press Yes key if results are accepted, No key if results are not accepted.
  • Now the system prompts for Review electronic signature enter the password, press continue and enter the comment and press enter.
  • Accept this comment message displays, press Yes if comment is accepted, No if comment is not accepted.
  • If No is pressed then enter the new comment and press enter, accept this comment message displays, press enter.
  • 21CFR11 back up in process message is displayed and the data backup is completed automatically.
  • Now press the Print/Send key and the report is printed.
  • Once the analysis is completed wipe off the sample with paper towel, clean the sample well using water or suitable solvent depending upon the nature of sample.
  • Enter the details of usage in the logbook.
• REFERENCES:

Not Applicable

• ANNEXURES: 

         ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:

• Controlled Copy No. 01  :          Head Quality Assurance
• Controlled Copy No. 02  :         Head Quality Control
• Master Copy                    :          Quality Assurance Department

• ABBREVIATIONS:

• REVISION HISTORY:             

CHANGE HISTORY LOG

Annexure-I
Refractometer User Logbook