Leak test apparatus Operational SOP

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