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
Remarks:
The
instrument is calibrated as per the written procedure and complies/ does not
comply with the acceptance criteria.
|
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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
|