SOP for Leak Tester : Pharmaceutical Guidelines

SOP for Leak Tester

Standard operating procedure of leak tester to perform the leak test for the tablet blisters in Quality Control.

1.0  Purpose

       To lay down the procedure for operation, calibration, and maintenance of leak tester.

2.0  Scope

       This SOP is applicable to leak tester present in Quality Control area.

3.0  Responsibility

       Quality control personnel.

4.0  Accountability

       Head of Department

5.0  Procedure

5.1  Principle:

5.1.1  The testing system is based on “Vacuum Decay Method”.
5.1.2  Vacuum decay method is an invasive, non-destructive method of inspecting pharmaceutical packs to ensure free quality product.

5.1.3  Working of instrument as follows:

When a vial is kept in the specified pocket on instrument and vacuum is applied, the instrument waits for maximum vacuum to be achieved. Once maximum vacuum is achieved vacuum is hold for a set time during, which the vacuum drop will be checked twice. The set properties for vacuum hold interval 1st and 2nd reading of vacuum. Difference between the vacuum level obtained at 1st and 2nd reading gives the vacuum drop called as vacuum decay, which should not be more than the DT – Threshold vacuum level set at the time of calibration using good and bad vials.
5.1.4  Any vial showing decay beyond set DT is considered as failing, where as any vial within set DT is considered as passing.

5.2  Preliminary checks:

5.2.1  Check the display of oil level in vacuum assembly.
5.2.2  Tubing shall be properly connected from vacuum assembly to machine and should have no cuts.
5.2.3  Ensure proper tightening of clamp, which connects the cup and assembly. Ensure that the cup is dry and free from moisture.

5.3  Machine Setting

5.3.1  Connect the vacuum assembly, printer and leak tester to the power supply.
5.3.2  Switch on the supply of vacuum assembly, printer and leak tester.
5.3.3  Machine will get switched on and main menu will be displayed having options: Achieve (Folder), Configuration (Folder with tools), Process (Car), Report (Folder with magnifying lens).
5.3.4  Open the archive by touching touch screen.
5.3.5  Archive submenu display following database: Password database (Keys), Models database (Foot Scale), Recipe database (bottle).
5.3.6  Select model database (Foot scale).
5.3.7  With ABC button, Enter model ID (vial type), Vacuuming time (in sec) 1st reading model (in sec), 2nd reading model (in sec), Threshold Model (in mbar), Minimum vacuum Model (in mbar), Average model (in mbars), Standard (in mbars).
5.3.8  Save the model.
5.3.9  Repeat step 5.3.7 for entering model of different vial type.
5.3.10  Select recipe Database (Bottle symbol).
5.3.11  Enter Recipe ID (vial type), Vacuuming time (in sec)1st reading model (in sec), 2nd reading model (in sec), Threshold model (in mbars), Minimum vacuum model (in mbar) as mentioned below.
Vial size
Vacuum time
st reading
nd reading
Min. vacuum
10 mL
2 sec
10 sec
10 mbar
720 mbar
40 mL
2 sec
10 sec
10 mbar
680 mbar
50 mL
2 sec
15 sec
10 mbar
650 mbar
100 mL
10 sec
15 sec
10 mbar
600 mbar
5 mL
2 sec
10 sec
12 mbar
720 mbar
15 mL
2 sec
10 sec
10 mbar
720 mbar
5.3.12  Save the model (Floppy).
5.3.13  Send model to RT (car with flag).
5.3.14  Exit recipe database (door)
5.3.15  Enter Configuration menu by touch screen.
5.3.16  Enter password configuration (Keys).
5.3.17  Make entries in password configuration page viz: password duration (in days), Password min lengths (numeric).
5.3.18  Password enabled depicted by ticked off box.
5.3.19  Exit password configuration (Door).
5.3.20  Enter system configuration page.
5.3.21  Make entries in N ACP cycle: 3, T vacuum ACP (in sec): 1.5, N model cycles: 5, max Y graph: 1000, min Y graph:0, max cons Rejects: 0.
5.3.22  Store the configuration.
5.3.23  Exit configuration door.
5.3.24  Enter Process Menu by touch screen.
5.3.25  Enter runtime page (Graph).
5.3.26  Enter data display page (Notepad).
5.3.27  Press the keypad button on the instrument to get the keypad on the screen.
5.3.28  Enter ID to the test to be carried out. (Standard / blank / product). 
5.3.29  Press ENTER on keypad.
5.3.30  Perform the confirmation by touching the BATCH.
5.3.31  Press the statistic generation (pie sign) on screen to enable data logging function.
5.3.32  Press the info sign (I in dialog box) to display information related with process or statistics.
5.3.33  Press reset data (cross with red background) to confirm the settings.
5.3.34  A pop up for reset confirmation will appear which is to be Okayed.
5.3.35  Note: The calibrated leak should always be false.
5.3.36  Print the statistical data by touching printer icon.
5.3.37  Exit the menu.
5.3.38  Load the vial to be tested in the pocket (standard / blank / product).
5.3.39  Press the vacuum switch (green color button at right hand side) to create vacuum in the pocket.
5.3.40  Open the cover of the pocket removes the vial.
5.3.41  Repeat step 5.3.38 to 5.3.40 for all the samples to be tested.
5.3.42  Get the print of result by touching printer icon.
5.3.43  Go to raw data display page by touching raw data icon (Notepad).
5.3.44  Print raw data of individual vial by touching the printer icon.
5.3.45  Cut the print and get it attached with the Test Data Sheet.
5.3.46  Enter the details of the instrument usage whenever use the instrument in  “Instrument usage log book”.
5.3.47  Enter the sample testing details in  “Leak testing report of sample”.

Related: SOP for Leak Test Apparatus

5.4  Calibration

5.4.1  Calibration of Leak tester:  Verify the instrument functioning with 10 runs on standard good dummy vial, which should pass100%.  Frequency: On the day of use, before first reading.  Enter the details in “Calibration of Leak tester”

5.5  Annual Calibration

5.5.1  Verify the instrument functioning with 20 runs on standard good dummy vials, which should pass 100 %.
5.5.2  Frequency: Once in a year.
5.5.3  Enter the details in “Calibration of Leak tester”

5.6  Major Breakdown

5.6.1  Failure of MMI or pressure sensor or vacuum pump.
5.6.2  Software change.
5.6.3  Card failure due to power failure. 

6.0  Abbreviation

6.1  SOP – Standard operating procedure

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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