Stability Chamber Calibration SOP



1.0  OBJECTIVE:
To lay down the calibration procedure of Stability chamber 30oC65% RH.
2.0  SCOPE:
This shall be applicable to the Stability chamber 30oC65% RH of Quality Control 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  Stability chamber 30oC65% RH.
5.2  Calibrated thermometer.
5.3  Hygrometer.
6.0  PROCEDURE:
6.1  Operate the stability chamber according to the SOP.
6.2  Keep the calibrated thermometer in three different locations top, middle, bottom. And note the readings in display of microprocessor. The difference between the calibrated thermometer and display should be NMT 0.5oC.
6.3  Keep the calibrated hygrometer in three different locations top, middle, bottom. And note the readings in display of microprocessor. The difference between the calibrated hygrometer and display should be NMT 1.0RH.
6.4  Record the result on the “Calibration Record”, “Calibration Log Book” & paste the “Calibration Status Sticker” on Stability chamber.
6.5  The following Quality Records shall be generated and managed in accordance with the Procedure for Control of Company Quality Records.
6.5.1        Calibration record.
6.5.2        Calibration status sticker.
6.5.3        Under calibration.
6.5.4        Calibration identification form.
6.5.5        Calibration identification log.
6.6  If the instrument does not produce reliable results or if the response is poor, label it as ‘UNDER MAINTENANCE’ & should be repaired or serviced.
6.7  Preventive maintenance is done whenever required.
6.8  Frequency:
6.8.1        Once in a month.
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 Stability chamber 30oC65% RH.












Annexure: 1
Calibration record of Stability chamber 30oC65% RH
CALIBRATION RECORD OF STABILITY CHAMBER 30oC65% RH
Calibration date
Date of last calibration done
Next due for calibration



INSTRUMENT DETAILS:
Name of equipment 
Frequency
Stability chamber 30oC65% RH


Thermometer:

Hygrometer:


Location
Temperature in digital display 
Temperature in calibrated thermometer  
RH in digital display
RH in calibrated hygrometer
Top




Middle




Bottom






Remarks: The instrument is calibrated as per the written procedure and complies/ does not comply with the acceptance criteria.
Calibrated 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
%
Percentage
RH
Relative humidity


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