SOP for Leak Tester

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 the instrument as follows:
When a vial is kept in the specified pocket on instrument and vacuum is applied, the instrument waits for the maximum vacuum to be achieved. Once the maximum vacuum is achieved vacuum is held 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, whereas 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 the 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 the main menu will be displayed having options: Achieve (Folder), Configuration (Folder with tools), Process (Car), Report (Folder with a magnifying lens).
5.3.4 Open the archive by touching the 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 the 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	1 st reading	2 nd reading	Threshold	Min. vacuum
10 mL	0.2	2 sec	10 sec	10 mbar	720 mbar
40 mL	0.2	2 sec	10 sec	10 mbar	680 mbar
50 mL	0.22	2 sec	15 sec	10 mbar	650 mbar
100 mL	0.3	10 sec	15 sec	10 mbar	600 mbar
5 mL	0.2	2 sec	10 sec	12 mbar	720 mbar
15 mL	0.2	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 touchscreen.
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 touchscreen.
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 the keypad.
5.3.30 Perform the confirmation by touching the BATCH.
5.3.31 Press the statistic generation (pie sign) on the screen to enable data logging function.
5.3.32 Press the info sign (I in a dialog box) to display information related to 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 a 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:
5.4.1.1 Verify the instrument functioning with 10 runs on standard good dummy vial, which should pass100%.
5.4.1.2 Frequency: On the day of use, before first reading.
5.4.1.3 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

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