1.0 OBJECTIVE:
To
lay down the calibration procedure of Leak test apparatus.
2.0 SCOPE:
This
shall be applicable to the Leak
test apparatus 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.
4.2
Head of the Q.C
Department.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Leak test apparatus.
5.2
Stop watch.
5.3
Sample (blisters/
strips).
6.0 PROCEDURE:
6.1
Switch ON the
mains.
6.2
Operate the leak test
apparatus according to SOP
6.3
Take calibrated
stop watch and start timer of leak test apparatus and stop watch
simultaneously.
6.4
Note the reading
at intervals of 60 seconds, 180 seconds & 300 seconds respectively.
6.5
Acceptance
criteria:
6.5.1
10 seconds for
each interval.
6.6
Vacuum gauge
calibration is done by external party.
6.7
Frequency:
6.7.1
12 months (for
timer, vacuum gauge & vacuum holding capacity).
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 Leak test apparatus.
Annexure: 1
Calibration
record of Leak test apparatus
|
CALIBRATION
RECORD OF LEAK TEST APPARATUS
Conclusion:
Satisfactory/ Not satisfactory.
|
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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
|