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QC SOP

SOP Title: Operation, Cleaning and Calibration of TLC UV Cabinet

SOP Title: Operation, Cleaning and Calibration of TLC UV Cabinet

  1. Objective:

To lay down the procedure for Operation, Cleaning and Calibration of TLC UV Cabinet.

  1. Scope:

This SOP is applicable for Operation, Cleaning and Calibration of TLC UV Cabinet 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 TLC UV Cabinet as per this SOP.
  • Engineering Department: To carry out preventive maintenance as per schedule and procedure defined.
  • 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 TLC UV Cabinet is fixed in the socket properly.  
5.1.2 Wear personal protective equipments such as hand gloves during operation of equipment.  
5.1.3 Ensure that the ON/OFF switch is working properly by switching “ON” the TLC UV Cabinet.             
    5.2 Operation:
5.2.1 Check the validity of calibration before starting any operations.  
5.2.2 Ensure that the equipment should be cleaned before operation.  
5.2.3 Switch ‘ON ‘the main electrical switch.  
5.2.4 Open the door of ultra violet cabinet.  
5.2.5 Keep the thin layer chromatography plate inside the cabinet.  
5.2.6 UV cabinet is suitable for wavelength 254 nm and 365 nm.  
5.2.7 Switch ON the required UV lamp, as per standard testing procedure.  
5.2.8 View the TLC plate and check the results obtained.  
5.2.9 After completion, open the door of ultra violet cabinet and remove TLC plate.  
5.2.10 Switch OFF the UV lamp and switch OFF the main electrical switch.  
5.2.11 Update the “Instrument/Equipment Usage Log Book” as per SOP.  

 

   5.3 Cleaning Procedure:
5.3.1 Clean the instrument with lint free cloth inside and outside before and after completion of the test.  
  5.4 Calibration Procedure:
  Frequency:  Once in a Year or after carrying out any major maintenance work.
5.4.1 Generate the A. R. No. on the “Instrument/Equipment Calibration Register” as per SOP number and give requisition to QA department for calibration formats of instruments on the due date of calibration.  
5.4.2 For issuance of calibration report refer QA SOP.  
5.4.3 Perform the calibration of instrument as per Annexure  and procedure mentioned below.  
5.4.4 Preparation  of  95%  ethanol: Add  10 ml  purified water  to 200 ml   volumetric  flask  and  make  up  the  volume  with ethanol and mix.  
5.4.5 Preparation  of  0.04% w/v  of  Sodium  Salicylate  in  95%  ethanol: Weigh  accurately  40 mg  of  Sodium  Salicylate  in  clean  and dry  100 ml  volumetric  flask  add  about 50 ml  of  95%  ethanol,  shake  to  dissolve and   make  up  the  volume  to  100 ml   with  95%  ethanol and mix.  
5.4.6 Preparation of 0.2% w/v  of  Sodium  Salicylate  in  95%  ethanol: Weigh accurately 100 mg of Sodium  Salicylate  in  clean  and dry  50 ml  volumetric  flask  add  about 30 ml  of  95%  ethanol,  shake  to  dissolve and  make  up  the  volume  to  50 ml   with  95%  ethanol and mix.  
5.4.7 Draw a line on the Silica gel 60 F254 and Silica gel 60 TLC plate in pencil at 1.5 cm from the bottom of the plate.  
5.4.8 Spot with glass syringe 5 micro litre of 0.04%w/v solution on Silica gel 60 F254 and 0.2%w/v solution on Silica gel 60 TLC plate of sodium salicylate on the line drawn of TLC plate.  
5.4.9 Put identification mark for the spots and allow the spots to dry in air.  
5.4.10 Examine the plate at 254 nm for 0.04%w/v spot and 365 nm for 0.2%w/v spot.  
5.4.11 Follow the same procedure from point no. 5.2.2 to 5.2.10.  
5.4.12 Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria.

Sr. No. Standards Acceptance Criteria Complies /

Does Not Complies

1. 0.04% w/v  of  Sodium  Salicylate  in  95%  ethanol The UV light at about 254 nm should reveal a standard spot of Sodium Salicylate with a diameter of about 5 mm on a TLC plate.  
2. 0.2% w/v  of  Sodium  Salicylate  in  95%  ethanol The UV light at about 365 nm should be capable of revealing standard spot of Sodium Salicylate with a diameter of about 5 mm on a TLC plate.  
 
5.4.13 Update the “Instrument/Equipment Usage Log Book”, “Annual Calibration Schedule” and “Monthly Calibration Schedule” as per “Calibration of Instruments and Equipments”.  
5.4.14 Affix the “Calibration Status Label” on the Instrument as per SOP “Calibration of Instruments and Equipments”.  
5.4.15 If calibration activity is outsourced, the values are to be transcribed in the Annexure and external party certificate to be attached.  
5.4.16 If any breakdown occurs, follow procedure as per SOP number “Calibration of Instruments and Equipments”.  

 

  1. Definitions / Abbreviations :

 

  • Abbreviations:
Abbreviation Expansion
SOP Standard Operating Procedure
QC Quality Control
QA Quality Assurance
0C Degree Celsius
No. Number
w/v Weight by volume
nm nanometer
TLC Thin Layer Chromatography
UV Ultra violet

 

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

 

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