Leak Test Apparatus – Operation and Cleaning SOP

Standard Operating System (SOP) for Operating, cleaning of Leak Test Apparatus which is used to check the leak seal test of packed strips, blisters, sachets, and bottle packs.

Procedure For Leak Test (Leak Test Apparatus)

1.0   PURPOSE:

    • The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for checking the Leak seal test of packed Strips, Blisters, Sachet packs, and Bottle packs.

2.0   SCOPE:

    • This procedure is applicable to carry out the leak seal test at the pharmaceutical plant of the below-mentioned packs.
      • Blisters (ALU-PVC, ALU-PVC/PVDC & ALU-ALU).Leak Test Apparatus
      • Sachet Pack
      • Bottles Pack

3.0   REFERENCES:

    • User Manual of Leak Test Apparatus

4.0   RESPONSIBILITY – SOP FOR LEAK TEST APPARATUS:

    • Operator / Production Dept. shall collect samples for leak seal tests at the specified time intervals during the stripping/blistering, bottle, and Sachet packing operation.
    • Operator / Production Dept. shall ensure the withdrawing of specified quantity as per the defined frequency and sending the sample to centralize the Leak seal test area for testing.
    • Production Dept. shall fill the Leak seal test intimation slip.
    • After completion of the Leak Seal test, the result shall be reviewed by the concerned Operator/Packing Department.
    • Operator / Production Dept. shall take necessary corrective action in case of result failure.
    • Operator / Production Dept. shall ensure the destruction of non-recoverable rejection generated during leak seal test.
    • The quality assurance shall ensure Leak Seal Test is performed as per the defined procedure. and frequency of filling of BPR and Equipment log book.
    • QA shall ensure the filling of the Leak Seat Test result in the BPR and equipment log.
    • The quality assurance shall initiate necessary corrective action if any discrepancies observed during testing.

5.0   ABBREVIATIONS – SOP FOR LEAK TEST APPARATUS:

    • ALM: Aluminium
    • BPR: Batch Packing Record
    • QA: Quality Assurance
    • SOP: Standard Operating Procedure
    • Dept: Department
    • NA: Not Applicable or Not Available.
    • PVC : Polyvinyl Chloride
    • PVDC: Polyvinyl Dichloride.

6.0   PROCEDURE – SOP FOR LEAK TEST APPARATUS:

  • Equipment: Leak Seal Test Apparatus shall be used to perform the leak seal test.
  • Checks and precautions during handling of Leak Test Apparatus:

    • Wear hand gloves while the opening of strips/blisters/sachets/bottles.
    • Use potable water for testing purposes.
    • The perforated disc should be immersed in Water of leak seal test apparatus
    • Before the starting of any batch, the leak test shall be carried out by the production and the same shall be verified by Quality Assurance (QA).
  • The frequency for leak seal test – Leak Test Apparatus:

    • Leak seal test shall be performed at the start of operation and at an hourly interval during the stripping operation.
    • In the case of Blister, Bottle filling and Sachet Leak test shall be performed at an interval of 2 Hours.
    • After every change over of lidding foil.
    • Completion of any maintenance work.
    • After the restart of a machine if more than 30 minutes stoppage in the packing department
    • In case of small batch (batch completed within 2 hours), leak test to be performed at the start, middle, and at the end of the batch.
  • Sampling for Leak Test :

    • The total number of strips/ blisters sealed by the full rotation of the sealing roller or plate shall be subjected for leak seal test.
    • In the case of bottles, two consecutive bottles shall be subjected for leak seal test (after sealing induction stage).
    • In the case of Sachet, five sachets are used for performing a leak test.
  • Part I – General Instruction – SOP for Leak Test Apparatus:

    • The operator of the respective area shall calculate the required number of strips/blisters/sachet/bottles for leak seal test as per defined frequency.
    • The number of samples required for the leak seal test shall be estimated by considering the type of change parts used for packing.
    • Respective operator/Production shall fill the leak seal test intimation slip as per Annexure-I.
    • All the samples collected for leak seal test shall be collected in a self-sealing poly bag and labeled the same as per Annexure-II.
    • Leak seal test sample along with intimation slip shall be forwarded by the operator/line officer to centralize the leak seal test area.
    • Representative of centralize leak seal test area shall ensure the receipt of sample & shall take the signature of concern on the leak seal test intimation slip, along with date and time.
    • After receipt of the sample from respective areas the representative of the leak seal test area shall log the details in the leak seal test logbook, (first in, first record, and test) concept shall be adapted.
    • The detail shall be recorded as per annexure-III.
  • Part II – General Instruction – SOP for Leak Test Apparatus:

    • Perform the testing of the leak seal test as per instruction/condition specified in the sample intimation slip.
    • After completion of testing defoiling of strips/blister to be done and check any leakage in the same.
    • Destroy the Strips/blisters/sachets/bottles and its contents after leak seal test.
    • If any discrepancies observed after testing, then inform the respective production/quality assurance for further course of action.
    • Production/quality assurance shall investigate for leak seal test failure and take necessary action.
    • Record the details in the respective batch packing record.
    • If required stop the machine.
    • Resume the line only after the implementation of necessary actions and removal of discrepancies.
    • Reconciliation of tablets used for leak seal test shall be ensured by Packing/Quality Assurance at the time of batch completion and shall perform the necessary entry in BPR.
    • Cleaning of leak seal test apparatus shall be done on a daily basis and date, Equipment ID, checked and remark column shall be recorded in Annexure –III. Put NA in not the relevant column.
    • In the case of Leak Test Failure:

    • Intimate the Department Head and QA
    • Quarantine the packed shipper between in-process checks Interval.
    • Perform random recheck of packed shipper for open pocket, sealing defective Strip /blister, etc.
    • Perform random sampling and do the leak test, if it passes inform QA and continue Packing activity.
    • In case of leak test fail, raise the observation, and carry out the investigation to find out the root cause and draw the corrective action.
    • In the case of Power Failure restart the apparatus and perform the leak test.
  • Procedure for Leak seal Test Apparatus (Model – NE/102):

    • Immerse the strips/blisters/sachet/bottle in a vacuum apparatus half-filled with water.
    • Check that the strips/blisters/sachet/bottles are completely submerged in water after covering with the disk and lid.
    • Apply vacuum till 350 mm ± 10 of Hg. (14 inches) equilibrium achieved.
    • Close the stopcock in such a way that the equilibrium maintained for 3 minutes.
    • Hygroscopic products (e.g Encorate/Decorate/Macorate/Korandilgroup etc.) apply vacuum till 381mm of Hg10mm of Hg (15 inches) achieved and follow the procedure as given above.
    • After 3 minutes open the stopcock and release the vacuum and wait for 1 minute.
    • Open the lid, remove strips/blister/ sachets/bottle and wipe off the water from the surface of the strips, blisters, sachets, and bottle with a clean dry duster.
    • Open the strips/blister/sachets/bottle by scissors/manually and carefully remove the content from the strips/blister/sachets/bottle by manually on a dry plate.
    • Examine the contents for stickiness or wetness.
    • If any product becomes sticky or wet then the blister /strip considering as failure in leak test
    • If any wet content observed, then inform to packing/Q.A.
    • Collect the used content of the leak seal test in a polybag for non-recovery and destroy.
    • Record and reconcile the same in the BPR.
  • Procedure for Leak seal test Apparatus (Model-LT-101P) :

    • Place the test sample in the vacuum apparatus filled with water to the desired level.
    • Connect the vacuum tube between desiccator and the “VACUUM INLET” nozzle, provided on the back panel of the instrument. Switch “ON” the power switch.
    • Press “Set” Key and set “vacuum” at 350 mm Hg ± 10 mm (14 inches).For Hygroscopic products (e.g Encorate/ Decorate/Macorate/Korandil group etc.) set “vacuum” at 381 mm Hg ± 10 mm (15 inches) by using UP and Down key.
    • Press “Set” Key and set “HOLD TIME” by using the UP and Down key.
    • Set HOLD time for 3 minutes.
    • Press “Set” Key and set “USER ID” by using up and down key.
    • Press “Set” Key and enter “NO OF SAMPLE” as per requirement by using the UP and Down key.
    • Then press “Set” Key and enter “B.No. XXXX” by using UP and Down key.
    • After all the data entry, press the enter key after that press “Run” key and wait for 03:00 min (While pressing a run key it shows a red indicator blowing in the m/c.).
    • Release the vacuum slowly after the hold time over the vacuum.

    • Open the lid, remove strips/blister/ sachets/bottle and wipe off the water from the surface of the strips, blisters, sachets, and bottle with a clean dry duster.
    • Open the strips/blister/sachets/bottle by scissors/manually and carefully remove the content from the strips/blister/sachets/bottle by manually on a dry plate.
    • Examine the contents for stickiness or wetness.
    • If any wet content observed, then inform to packing as well as Q.A., check for the cause and reset the machine and retest for the leak seal test.
    • Record the readings in the logbook.
    • Collect the used content of the leak seal test in a polybag for non-recovery and destroy it. Record and reconcile the same in the BPR.
    • Tolerance:

    • None of the content of the strips/blister/sachets/bottles found moist /wet after the leak seal test.
  • Cleaning procedure for leak test apparatus:

    • Clean the instrument daily as follows:
      • Clean the vacuum apparatus with potable water and scrub with the help of scrubber.
      • Rinse the vacuum apparatus with potable water for not less than 1 minute.
      • Finally, rinse the vacuum apparatus with potable water for not less than 1 minute.

7.0   ANNEXURES:

Annexure 1: Leak Seal Test Intimation Slip

Product Name Generic Name
Batch No. Line No.
Sample Qty. in Unit Specification 350 mmHg ±10 of Hg. (14 Inches)
381 mmHg ±10 of Hg. (15 Inches)
Date Time Shipper No. Sampled by Received By Leak Seal Test Equipment ID. Leak Test Done By Result (Pass/Fail) Checked By Non recovery Destruction Yes/No
Total Qty. of Nonrecovery………………… Units.

 

Annexure 2: Leak Seal Test Sample Label

Leak seal test Sample label

Product Name:
Batch No.:
Line No.:
Sampled  By:(Signature)

Annexure 3: Leak Seal Test Apparatus Log Book

Dept.: Area:  Equipment Name:
Date Time of sampling Product Batch No. Line No Time of testing Leak seal test Equipment ID. Checked By Name Observation PASS/FAIL Remarks (if any)

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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