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SOP for Calibration of Thermometer


Standard operating procedure of calibration of thermometer using standard thermometer certified by Approved Laboratory.

1.0  OBJECTIVE 

       To describe the procedure for calibration of thermometer.

2.0  SCOPE

       This SOP is applicable for calibration of thermometer.

3.0  RESPONSIBILITY

       Quality control  executive

4.0  ACCOUNTABILITY

       Manager – Quality control

5.0  PROCEDURE

5.1  Calibration Procedure

5.1.1  The thermometer for calibration shall be mercury in glass type.
5.1.2  Take a 1000 ml beaker filled with about 850 ml of Silicon oil. Use water for (0–0°C) and silicon Oil for the temperature above 50°C.
5.1.3  Put the beaker in a oil bath fitted with a stirrer. The stirrer shall be dipped in the beaker leaving about 2 cm space from the bottom of beaker.
5.1.4  Immerse the standard thermometer certified by Approved Laboratory, into the silicon oil vertically approx. 8.0 cm leaving the remainder of the stem and the upper expansion chamber exposed to ambient temperature. Clamp tightly.
5.1.5  Immerse the thermometer to be calibrated into the silicon oil vertically. The mercury bulb of the thermometer shall be placed at the same level of the mercury bulb of the standard thermometer. Clamp tightly.
5.1.6  In case of minimum/maximum thermometers, at the time of calibration, ensure that both the arm should show the same temperature.
5.1.7  Start the stirrer taking precaution that it does not touch the thermometers.
5.1.8  Start heating the oil bath at the rate of 2°C per minute and compare the temperature observed at different increments (Annexure - I).
5.1.9  The temperature difference shall not be more than ±2°C. Any thermometer found beyond the acceptable limit shall be discarded. .

5.2  Identification Number

5.2.1  Identification number shall have 8 characters.
5.2.2  The first two character shall always be T and C respectively.
5.2.3  The third character shall be dash (-).
5.2.4  The fourth & fifth character shall be numeric and denote original number.
5.2.5  The sixth character shall be slash (/).
5.2.6  The seventh & eighth character shall be numeric and shall denote number of re-calibration.
5.2.7  A typical example shall be as follows: TC-01/01
5.2.8  The thermometer shall have an identification number and standardization date labeled on it.
5.2.9  All thermometers shall be standardized once a year and calibration record maintained (Annexure - II).
5.2.10  Standard thermometers shall be sent for re-standardization based on the calibration certificate given by the Approved Laboratory.
5.2.11  Alternatively calibrated thermometer can also be used.

6.0  ABBREVIATIONS:

6.1  SOP - Standard Operating Procedure
6.2  No. - Number
6.3  QA - Quality Assurance
6.4  NA - Not Applicable
6.5  CCF - Change control format
6.6  QC - Quality Control
6.7  R&D - Research and Development


ANNEXURE – I
S. NO.
 RANGE OF THERMOMETER
SET TEMP. FOR STANDARDISATION

1

- 10°C to 50°C
i)  12°C 
ii)  25°C
iii) 38°C
iv) 50°C    

2

- 10°C to 110°C
i)   25°C
ii)  50°C  
iii) 80°C 
iv) 110°C   

3

- 10°C to 250°C
i)    60°C
ii)  120°C
iii) 180°C
iv) 220°C

4

- 10°C to 360°C
i)    60°C
ii)  120°C
iii) 180°C
iv) 250°C

Note:  If a pre-certified/calibrated thermometer is used the range given in the certificate shall be used for standardization instead of above set temperatures.



ANNEXURE - II

STANDARDISATION RECORD
NAME OF EQUIPMENT                     :  THERMOMETER
THERMAMETER Sr.No                      :
FREQUENCY                                      :  YEARLY

IDENTIFICATION NO. OF STD. : 
THERMOMETER

DATE OF STANDARDISATION
THERMOMETER NO.
SET
TEMP.
STANDARD
THERMOMETER
OBSERVED GAUGE IN MM
THERMOMETER TO BE STANDARDISED
REMARKS
CALIBRATED BY
CHECKED
BY
CORRECTION
TO READING
ACTUAL
TEMP.
TEMP.
OBSERVED
CORRECTION
TO READING






Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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