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 22^oC. 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 0.5^oC.

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 37^oC, 44^oC and 55^oC.

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