SOP ON CLEANING, OPERATION, AND CALIBRATION OF LEAK TEST APPARATUS

SOP ON CLEANING, OPERATION, AND CALIBRATION OF LEAK TEST APPARATUS

PURPOSE: To define a Cleaning, Operation, and calibration procedure for Leak test apparatus.

SCOPE: This SOP applies to the Cleaning, Operation, and calibration of the Leak test apparatus.

CROSS-REFERENCE DOCUMENTS:

• Document(s) and Data Control Procedure

ATTACHMENTS

OTHER RESOURCES: MASTER FORMULA OF CIPROFLOXACIN, FLUOCINOLONE, AND CLOTRIMAZOLE CREAM

 RESPONSIBILITY: 

1. QA Person shall be responsible for the following: 

• To operate and calibrate the instrument as per SOP.

2. Production Person shall be responsible for:

• To operate and calibrate the instrument as per SOP

Head-QA/Designee shall be responsible for:

• To ensure implementation of the system as per defined SOP.

PROCEDURE:

SAFETY/PRECAUTION:

• Ensure that the Instrument is clean and free from dust etc.
• The water of the desiccators should be removed frequently to maintain the cleanliness.

Cleaning:

• Disconnect the instrument from the main power supply.
• Clean the apparatus accessories with the help of a clean dry lint-free cloth or suitable brush daily.

Operation Procedure for Tablets/Sachets:

• Switch On the main power supply and main leak test apparatus.
• Ensure the connection of the pipe to the hood of the leak test tub.
• Ensure that a sufficient amount of purified water or 0.1 % solution of Methylene Blue should be present in the tub.
• Keep the blisters/ Strips/ sachets equivalent to one rotation of the sealing roller in desiccators.
• In case of a bottle leak test, Keep the bottles over the perforated disc in desiccators in an inverted position, and place the number of bottles in the desiccator after induction sealing equivalent to the No. of capping heads while in the case of screw capping place the number of bottles equivalent to the No. of capping heads
• Place the desiccator lid over the bowl properly.
• Switch On the main power supply.
• Switch On the power button on panel.
• Set the desiccator’s lid properly on bowl and close the vent plug tightly.
• Press the RESET button and set the timer for 180 sec.
• Press START button.
• The set time on the digital timer has elapsed when getting the desired reading on the gauge i.e. 15 inches, (380 mmHg).
• Vacuum pressure was maintained on 15-inch (380 mmHg) mercury pressure exactly for one minute.
• Rotate the control switch clockwise to prevent the creation of more vacuum.
• Switch OFF the main button and remove the vacuum by rotating the CONTROL knob Anticlockwise.
• Slowly release the vacuum with a red color knob on the desiccators.
• Remove the strips/ Blisters/sachet from desiccators and wipe off with tissue paper to remove the traces of solution.
• In the case of Blisters/ Strips/sachet, De-foil and examine the content in each
• Strips/blisters, if the tablets/powders are wet or colored or if moisture is present then there is leakage.
• Keep the scrap in a dedicated container.

Operation Procedure for Bottles:

• Switch On the main power supply and main leak test apparatus.
• Ensure connection of the pipe to the hood of the leak test tub.
• Ensure that during leak test of bottles no water should be present in the tub and tub should be dry properly..
• Wrap the each bottles with tissue paper or butter paper.
• Keep the bottles over the perforated disc in desiccators in inverted position, place number of bottles in desiccator after induction sealing equivalent to the No. of capping heads while in case of screw capping place number of bottles equivalent to the No. of capping heads
• Place the desiccators lid over the bowl properly.
• Switch On the main power supply.
• Switch On the power button on the panel.
• Set the desiccator’s lid properly on the bowl and close the vent plug tightly.
• Press the RESET button and set the timer for 180 sec.
• Press the START button.
• The set time on the digital timer has elapsed when getting the desired reading on the gauge.
• Vacuum pressure was maintained between 350 mmHg to 450 mmHg mercury pressure exactly for one minute.
• Rotate the control switch clockwise to prevent the creating of more vaccum.
• Switch OFF the main button and remove the vacuum by rotating the CONTROL knob
• Anticlockwise.
• Slowly release the vacuum with a red color knob on the desiccators.
• Remove the bottles from the desiccators and examine each bottle for leakage.
• if the wrapped tissue papers are wet or if moisture is present then there is leakage or fail in the leak test.
• Keep the scrap in a dedicated container.

Calibration:

• Instrument pressure gauge calibration is done by an outside party.
• Report any discrepancy observed during calibration or operation of equipment to Q.A
• Head and Affix an ‘UNDER MAINTENANCE’ label on the instrument.

Frequency

• Yearly ± 30 days.

MORE: PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS