STANDARD OPERATING PROCEDURE LEAK TEST FOR STRIPS

STANDARD OPERATING PROCEDURE

SUBJECT :                     LEAK TEST FOR STRIPS

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines for performing leak test of Strips.

2.0       POLICY:

Periodical checking of strips during packing and ensure zero leak strips.

3.0       PROCEDURE:

3.1       Apparatus required Vacuum Pump, Vacuum Desiccators.

3.2       The strips are selected at random during packing at regular intervals.

3.3       The strips are checked for visual defects like holes on foil, pouch opening, foil tearing etc and only intact strips are subjected for testing.

3.4       The strips are immersed in water and a porcelain disc is kept on the strips to keep them immersed in water during the test.

3.5       The Vacuum desiccators is closed and the opening of the sleeve is aligned with the opening on the top projection of the lid.

3.6       Vacuum pump is connected to the sleeve opening by means of a rubber tube & the vacuum pump is switched on. The pressure display on the gauge is 15 inches Hg.

3.7       The strips are immersed in water during the test.

3.8       The Vacuum Pump is kept on for one minute .The pump is switched off and the sleeve is brought to close position by rotation.

3.9       The strips are examined for any leakage after one minute.

           

3.10     There should not be any leakage.

3.11     If leakage is noticed the strip packing machine sealing rollers are cleaned with liquid paraffin and wire brush.

3.12     The strips are once again checked after cleaning this is done for strip pack product with Aluminium foil.

4.0       FREQUENCY:  As and when required.

5.0       RESPONSIBILITY:  Executive Q.A / Jr. Executive and Strip Packing Operators.

6.0       REVIEW GUIDE: In-process record.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x