1.0 OBJECTIVE:
To
lay down the operating 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
Methylene blue colour.
5.3
Sample (strips).
6.0 PROCEDURE:
6.1
Operation
of the instrument:
6.1.1
Ensure that instrument
is clean whenever clean according to SOP.
6.1.2
Take required
quantity of blisters from sample received in QC dept.
6.1.3
QC officer shall
perform leak test as procedure given below:
6.1.3.1
Ensure apparatus
bath is filled with purified water up to mark indicated and add methylene blue
in water.
6.1.3.2
Cover the leak
test chamber by using lead and place on it.
6.1.3.3
Connect the three
pin plug to the mains put “ON” the main instrument will glow “ON” set the timer
by up/down key then press the start key to process.
6.1.3.4
Any increase or
decrease of the vacuum inside the container can be controlled by release value
provided on the apparatus.
6.1.3.5
As soon the vacuum
gauge indicates 200mm of Hg then close the control value so that the vacuum
starts developing within 30-45 seconds which will be indicated on the vacuum
gauge fixed at the unit.
6.1.3.6
The sample remains
at the required vacuum level for given time interval buzzer will sound after
time is over and it will cut off the vacuum pump.
6.1.3.7
After the test is
over put “OFF” the mains and release the inside vacuum by pushing out the
controlled stopper.
7.0 REVISION LOG:
Revision No.
|
Effective Date
|
Reason
|
00
|
|
New
SOP
|
8.0 REFERENCES:
8.1
Not Applicable.
9.0 ANNEXURES:
9.1
Not Applicable.
10.0
ABBREVIATIONS:
Abbreviation
|
Expanded Form
|
SOP
|
Standard operating
procedure
|
&
|
And
|
No.
|
Number
|
Ltd.
|
Limited
|
Q.C
|
Quality control
|
QCEO
|
Quality control
equipment operation
|
F
|
Format
|
mm
|
Millimeter
|
Hg
|
Mercury
|
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