Stability Chamber Calibration SOP

1.0 OBJECTIVE:

To lay down the calibration procedure of Stability chamber 30^oC65% RH.

2.0 SCOPE:

This shall be applicable to the Stability chamber 30^oC65% 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 30^oC65% 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 0.5^oC.

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 30^oC65% RH.

Annexure: 1

Calibration record of Stability chamber 30^oC65% RH

CALIBRATION RECORD OF STABILITY CHAMBER 30^oC65% RH

Calibration date	Date of last calibration done		Next due for calibration

INSTRUMENT DETAILS:
Name of equipment		Frequency
Stability chamber 30^oC65% 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
QCE_B	Quality control equipment calibration
F	Format
^oC	Degree centigrade
%	Percentage
RH	Relative humidity