Digital Hot Incubator Calibration SOP



1.0  OBJECTIVE:
To lay down the calibration procedure of hot incubator to provide a system to calibrate, control and maintain the equipment used for inspection measuring and test equipment in order to ensure the correctness of measurement and test status.
2.0  SCOPE:
This shall be applicable to the hot incubator of Quality Control Instrument Laboratory.
3.0  RESPONSIBILITY:
3.1  Technical Assistant/ Helper.
3.2  Q.C Analyst.
4.0  ACCOUNTABILITY:
4.1  Manager-Quality Control.
5.0  MATERIAL AND EQUIPMENT:
5.1  Hot incubator.
5.2  Calibrated thermometer.
6.0  PROCEDURE:
6.1  Operate the Hot incubator according to the SOP.
6.2  Fix the temperature gauge of the hot incubator at the 22oC. Wait till the set temperature is reached.
6.3  Take the calibrated thermometer in 500.0ml of beaker filled to ¾ of the volume with glycerol AR grade.
6.4  Keep the beaker inside, at the center of the incubator.
6.5  Close the door. Allow the temperature to equilibrate for 30 minutes.
6.6  Observe the temperature shown by the calibrated thermometer and the temperature shown by the display thermometer.
6.7  The temperature of calibrated thermometer should not differ by more than 0.5oC.
6.8  Record the temperature at two time intervals (with a gap of 6hours) in temperature record.
6.9  By following the point 6.1 to 6.7 carry out calibration by setting the incubator temperature at 37oC, 44oC and 55oC.
6.10 Record any discrepancy observed during operation or during temperature monitoring to Quality Control Executive and notifies the defect to technical assistant for rectification. Affix “BREAKDOWN” label on the instrument.
6.11 Record the result on the “Calibration Record”, “Calibration Log Book” & paste the “Calibration Status Sticker” on Hot incubator.
6.12    Frequency:
6.12.1    Once a month and after each maintenance job.
6.13    Record the results on the Calibration Record, Calibration Identification Log and paste the Calibration Status Sticker on the hot incubator.
6.14    The following quality records shall be generated and managed in accordance with the procedure for control of company quality records.
6.14.1    Calibration record.
6.14.2    Calibration status sticker.
6.14.3    Under calibration.
6.14.4    Calibration identification form.
6.14.5    Calibration identification log.
7.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

8.0  REFERENCES:
8.1  Not Applicable.
9.0  ANNEXURES:
Annexure 1: Calibration record of hot incubator.




Annexure: 1
Calibration record of Hot Incubator.
CALIBRATION RECORD OF HOT INCUBATOR
Calibration date
Date of last calibration done
Next due for calibration




Instrument details
Instrument name
Instrument make
Instrument identification No.
Hot Incubator


Location:

Frequency:

Observation Chart
Equilibration time= 30minutes.
Note: 2nd interval must be done after 6 hours of 1st interval.
Set temperature of hot incubator
(oC)
Intervals record
Temperature of calibrated thermometer observed
(oC)
Temperature of display thermometer of hot incubator
(oC)
Tolerance
Observed by
22oC
1st interval


±0.5oC

2nd interval


±0.5oC
37oC
1st interval


±0.5oC

2nd interval


±0.5oC
44oC
1st interval


±0.5oC

2nd interval


±0.5oC
55oC
1st interval


±0.5oC

2nd interval


±0.5oC





Remarks: The calibration procedure of instrument is within tolerance limit and gives satisfactory/ not satisfactory results.
Calibration by/date:
Checked by/date:

















10.0    ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
Q.A
Quality assurance
QCEB
Quality control equipment calibration
F
Format
oC
Degree centigrade


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