CLEANING AND OPERATION OF LEAK TEST APPARATUS

1. OBJECTIVE

To lay down the procedure for Cleaning and Operation of Leak test apparatus.

• SCOPE

This SOP is applicable for Cleaning and Operation of Leak test apparatus in packing area.

3.0       RESPONSIBILITY

            Production, QA & operator      : To follow the procedure

4.0      ACCOUNTABILTY

      QA & Head Production                  : For system compliance

•  PROCEDURE       
  • Cleaning :
    • General Cleaning:

Clean the chamber with lint free cloth after every leak test performed.

• At the time of shift end:Disconnect the power supply.Dissemble the plastic vacuum chamber. Remove the perforated plate.
• Take the part of leak test apparatus in washing area.
• Drain the water wash the vacuum chamber with potable water and finally rinse with purified water.
• Finally mop the chamber using 70% IPA with lint free cloth.After cleaning assemble the vacuum chamber.

• Operation:
• Procedure for Blister / Bottle checking:
• Ensure the cleanliness of the equipment.Ensure that there shall not be any remainants of previous product used in the instrument.Take the exact number of blisters / Bottle and dip them into the water in the vacuum chamber.
• Place the perforated plate over the blisters / Bottle and place the lid of vacuum chamber.Connect the vacuum chamber to the vacuum pump.
• Switch “ON” the vacuum pump.
• Apply 380 inches of Hg vacuum hold the vacuum for 1minutes.Switch “OFF” the vacuum pump.
• Release the pressure slowly and take out the blisters / Bottle.
• Wipe the blisters / Bottle with tissue paper to remove the water.De-foil the blisters and open the seal of bottle and observe the presence of moistness / water inside the pockets.If the test complies then inform the operator to run the machine.
• If moistness or water is found inside the pockets, strips are failing in the test, and then take the corrective action.
• Set the machine properly and repeat the procedure till it passed leak test.Enter the details in the BPR and log book for inprocess checks.
• Clean the leak test apparatus as per above procedure.
• After completion of leak test defoiled the blisters after defoiling put empty defoiled blisters  in waste bin and capsules in another west bin.At the end of shift transfer the capsules for destruction.

6.0       TRAINING

Trainer   : Head Production Department

Trainees : Staff and machine operator of the Packing section and QA chemist.

7.0       DISTRIBUTION

Master Copy                     :          QA Department

Controlled Copy               :           Production Department  

Display Copy                    :           Production Department (If Required)

  8.0 ATTACHMENTS

Sr. No	Annexure No.	Title	Format No.
1	NA	NA	NA

• REFERENCES        

In-house

10.0 ABBREVIATION

Abbreviation	Extended Form
EG	Engineering
SOP	Standard Operating Procedure
QA	Quality Assurance
WH	Warehouse
NA	Not Applicable
MB	Microbiology

      11.0 REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.
1	NA	New SOP	00