SOP for Calibration of Hot Air Oven : Pharmaceutical Guidelines

SOP for Calibration of Hot Air Oven

Standard operating procedure of evaluation of hot air oven used in Quality Control.

1.0 OBJECTIVE

To describe the procedure for the calibration of the hot air oven

2.0 SCOPE

This SOP is applicable for the calibration of hot air oven.

3.0 RESPONSIBILITY

Officer /Executive - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control.

5.0 PROCEDURE

5.1 For the calibration of hot air oven use a standard thermometer ranging up to 300º C.
5.2 Start the calibration procedure after 1 hour of staring the oven.
5.3 Set the oven at desired temperature.
5.4 Put the standard thermometer for 30 minutes on the upper shelf of the oven and close the door of the oven.
5.5 After 30 minutes open the door of the oven and read the temperature of standard thermometer randomly and match the observed temperature of the thermometer.
5.6 Repeat the above procedure by putting the thermometer in lower shelf for 30 minutes.
5.7 Record the observed temperature in calibration record of hot air oven as per Annexure no. I
5.8 The observed temperature of the thermometer in both shelves should be ± 2.0º C tolerance limit to the set temperature value.
5.9 Frequency: Once in a month.
Related: SOP for Validation of Oven for Depyrogenation

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

ANNEXURE- I
CALIBRATION RECORD OF HOT AIR OVEN
Inst. ID  No.
:

Ref.  SOP No.
:

Make
:

Model No.
:
  
Date of Calibration     :
Next Due Date           :
Location                     :
Frequency: Monthly  :
Location
Set Temperature
Observed Temperature 
Tolerance
Observed By
Upper shelf


±2.0º C

Lower shelf


±2.0º C

Remark: The calibration procedure of instrument are within tolerance limit /out of tolerance limit and gives satisfactory / not satisfactory results.
Analyst                                                                                                     Checked by
Date                                                                                                          Date

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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.
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