OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN

SOP No.:
QUALITY CONTROL DEPARTMENT Page 1 of 2
QCG0036
Supersedes : Effective Date :
STANDARD OPERATING PROCEDURE
00 April 2010
Version No. : OPERATION AND CALIBRATION OF Review date:
01 LEAK TEST APPARATUS March 2013

1.0 OBJECTIVE:

To describe the procedure for the “Operation and Calibration of Leak
Test Apparatus.”

2.0 SCOPE:

This SOP is applicable to “Operation and Calibration of Leak Test
Apparatus” at M/s. Oasis Laboratories Private Limited, Dehradun.

3.0 RESPONSIBILITY:

Quality Control Department

4.0 ACCOUNTABILITY:

HOD – QC

5.0 PROCEDURE:

5.1 Fill the bath provided in the instrument with DM water up to plastic
plate with pores.

5.2 Add 0.5% methylene blue to the water in order to detect leakage
Clearly (0.1% methylene blue).

5.3 Place the lid of the bath attached with the pipe for vacuum properly.

5.4 Switch ON the red switch named ‘Main’s’.

5.5 Rotated the timer and adjust the time to 10 min.
5.6 Let the vacuum build inside the bath covered with lid.

Designation Signature Date

Prepared by Chemist- QC

Reviewed by Manager- QC

Approved by Manager- QA

DEHRADUN SOP No. 5. 8.: QUALITY CONTROL DEPARTMENT Page 2 of 2 QCG0036 Supersedes : Effective Date : STANDARD OPERATING PROCEDURE 00 April 2010 Version No. 6.10 Vacuum gauge shall be calibrated annually. 7.9 After the holding period release the vacuum.0 RECORD: Calibration by outside agency once in year. 9.0 ANNEXURE: Attach Calibration certificate of outside agency. Dept. : Department. : OPERATION AND CALIBRATION OF Review date: 01 LEAK TEST APPARATUS March 2013 5. and check the strips/blisters for any leakage by defiling them. 5.QC Reviewed by Manager. OASIS LABORATORIES PRIVATE LIMITED. 5.8. HOD : Head of the Department.QC Approved by Manager.0 ABBREVIATIONS & DEFINITIONS: SOP : Standard Operating Procedure.QA . Open the lid and take out the blisters / strip and wipe them using a dry cloth.0 MAINTENANCE: If the instrument does not produce require calibration results or its response is poor then it should be labeled ‘Faulty’ and should be repaired or serviced. QC : Quality Control Designation Signature Date Prepared by Chemist.7 When vacuum gauge of the instrument shows pressure of 400 psi (15 lbs) switch off the instrument and hold the vacuum for 3 min.