1. OBJECTIVE
To lay down the procedure for operation, Cleaning and Calibration of Leakage tester
2. SCOPE
This procedure is applicable to Quality Control Department
3. RESPONSIBILITY
• Officer QC
• Manager QC
4. SAFETY INSTRUCTIONS
• Proper handling the instrument.
• Don’t switch on the main board with wet hands
5. PROCEDURE
5.1 OPERATION
5.1.1 Take required quantity of blister/ vials from the sample received in QC department.
5.1.2 Ensure apparatus bath is filled with purified water up to the mark indicated and add 0.5% crystal violet solution in the water.
5.1.3 Cover the leak test chamber by using lid and place on it.
5.1.4 Connect the plug to mains put “ON” the mains, instrument will glow “ON”
5.1.5 Set the timer by up down key then press the start key to process.
5.1.6 Any increase or decrease in vacuum inside the container can be controlled by release valve provided on the apparatus.
5.1.7 As soon the vacuum gauge indicates 400mm of Hg then close the control valve so that vacuum start developing within 40 to 45 seconds which will indicate on vacuum gauge fix at the unit.
5.1.8 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.
5.1.9 After the test is over put “OFF” the mains and release the inside vacuum by pushing out the controlled stopper.
5.2 CLEANING
5.2.1 Switch “OFF” the mains.
5.2.2 Cleaning of leakage test apparatus by using purified water.
5.2.3 Clean outer and inner surface with the help of lint-free cloth.
5.2.4 Place the apparatus for dryness foe half hour.
5.2.5 Change the desiccators water twice a week or as per required.
5.3 CALIBRATION
Frequency: Twelve months (for the timer, vacuum gauge and vacuum holding capacity)
5.3.1 Switch on the power
5.3.2 Take a calibrated stopwatch and stat the timer of leak test apparatus and stop watch simultaneously.
5.3.3 Note the reading at interval 60 seconds, 180 seconds, and 300 seconds respectively.
5.3.4 Acceptance Criteria: 10 seconds for each interval.
5.3.5 Vacuum gauge calibration done by the external party
6. RELATED DOCUMENTS
Operational Log Book Format – Annex. I
Cleaning Log Book Format – Annex. II
Calibration Report Format – Annex. III
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
DISTRIBUTION INDEX
Distributed To Copy No. Received By/Date
Quality Control Department 01
8. ABBRIVIATIONS
Q.C Quality Control Department
9. REVISION HISTORY
Revision No Issue Date Supersedes
Reason of Change/ Description
Revision No. Dated
00 25-12-2015 NA NA First Version
01 01-11-2020 00 25-12-2015 Due to revision date is over. And change in format