Vacuum leak test machine
To provide a written procedure for cleaning, operation, monitoring & precaution of vacuum leak test machine.
Vacuum leak test: A vacuum leak test is the process to detect the weak part of the body or joints in the container by means of a vacuum. This process is carried out in the vacuum chamber with an adjustable process cycle time & a vacuum pump evacuates the test chamber & test container simultaneously.
Originating department shall be responsible:
- Preparation of SOPs.
- To provide the final draft copy to Quality Assurance.
- To follow the described herein.
- To maintain the record.
- To impart the training of the SOP to concerned personnel before the effective date of SOPs.
- To verify that employees are trained before performing or operating any task relevant to The SOP.
- To perform the cleaning & operation of equipment.
The head of Originating department/designee shall be responsible for:
- Checking of the SOP for procedural, technical content, accuracy and cGMP compliance.
- To get the SOP approval from the Head of Quality Assurance or designee.
- To impart the training on SOP to the concerned personnel in between the approval date and the effective date of the SOP.
- After training the user department Head or designee to ensure the implementation of the SOP on the effective date.
- To maintain the controlled copies of the SOPs at the required location.
- To ensure the compliance of SOP.
The Quality Assurance department shall be responsible for:
- To checking of the draft SOP from technical, function, regulatory and cGMP compliance perspectives.
- To maintain the approved master copy of the SOP of all departments for document control.
- To issue the required number of controlled copies to the departments and document the same.
- Issuance of change control form required for new or SOP revision.
- Destruction of earlier/superseded controlled copies of SOP in case of new SOP implementation as per procedure and document same.
- To retrieve the controlled copy of the SOP when it is superseded/obsolete & maintain its record.
- To verify that all the instructions are followed properly as per the given SOP.
- To ensure implementation of SOP.
Head – Quality Assurance/ Designee shall be responsible for:
- To approve new or revised SOP.
- Review of draft SOP for technical, function, regulatory and cGMP compliance.
- Final approval of the SOP by signing off as approved by.
- To ensure the implementation of the defined system.
The engineering person shall be responsible for:
- Coordinate with the production person to schedule preventive maintenance of equipment.
- Perform maintenance of the system as per respective SOP.
- To maintain the record of preventive maintenance.
- Never spray any disinfectant or water directly on the HMI of the machine.
- Don’t open the lock of the chamber while it is in operation.
- Don’t run the vacuum pump without oil.
- Don’t stand near the machine while it is in operation.
- After completion of the day’s operation switch off the mains of the machine.
The vacuum leak test chamber is an SS304 square/rectangular shape equipment, having one end fixed & another door in front fitted on hinges with a gasket & lock for tightening the chamber door. It has inside SS racks which are suitable for SS perforated trays. It is mounted on a pedestal fitted on a heavy-duty rectangular pipe frame on two sides. It has provided a side shaft for rotation on the stand. Through one of the mounting shafts, the vacuum line is connected to the vacuum pump. It is equipped with a touch screen HMI with PLC to set the programme & vacuum retention in the chamber. The chamber rotates mechanically “thro” on the rotation of 180º in one direction & returns to the original position (one cycle). It has provided one vacuum gauge on the face of the front door.
- Before starting the operation, clean the equipment & S.S. chamber properly with IPA 70% solution.
- Clean all perforated trays properly with purified water If any sticky traces are there then wash with Teepol solution followed by purified water & finally clean with IPA 70% v/v solution.
- Clean the chamber with purified water while leak ampoules solution spread in the chamber.
Checkpoints before starting the operation
- Check the vacuum leak test area is properly clean & no other product ampoules are there.
- Check the vacuum leak test machine is clean from the inside as well as outside.
- Clean there should be no other or previous product ampoules should be there in the machine.
- Check & verify that the vacuum gauge is properly calibrated.
- Check the door gasket is not damaged or torn & properly fixed in the groove of the chamber.
- Check the level of vacuum pump oil is sufficient before operation.
- Check the HMI/PLC of the vacuum leak test machine is properly working.
- After getting line clearance from QA open the leak test chamber & load the ampoules in trays as per the loading pattern.
- Arrange the ampoules/ampoules cassettes vertically in SS perforated trays.
- Load trays in the chamber as per the machine capacity & the loading pattern is as follows.
|Ampoules per tray
|Total No. of Ampoules in one lot of 5 trays
|1780 x 5 = 8900
|1096 x 5 = 5480
|768 x 5 = 3840
- Close the front door of the machine & tighten the locks properly.
- Check the emergency switch in the release position.
- Switch “ON” the “MAINS” electrical supply of the machine.
- Switch “ON” the control panel of the machine with the red colour ON/OFF switch & HMI will start & home screen will display.
- Go to the “SET PARAMETER” on the home screen & enter the password & go to “SET PARAMETER 1”.
- Check the machine parameter (Vacuum pressure, forward hold time, reverse hold time, process end pressure, print internal) with “SET PARAMETER”.
- Enter the batch detail (Operator name, product name, batch no., lot no., load quantity).
- After entering all detail check the connectivity of the printer to the machine, it should be properly connected.
- Select the operation mode “Auto mode/manual mode” with the HMI & run the cycle.
- In “AUTO MODE” press the red colour “STOP” icon on HMI & cycle will start automatically & after completion of the cycle up to the set time cycle will be stopped.
- In “MANUAL MODE” press the red colour “AUTO” icon and it will turn into green colour “MANUAL” & cycle will turn in manual mode.
- After that Press one by one all remaining red colour icons displayed on HMI (VACUUM PUMP OFF, UPWARD OFF, RELEASING VALVE OFF, INWARD OFF).
- All icons will become green & cycle will run in manual mode.
- The cycle time of the vacuum leak test machine is fixed at 20 minutes for all types of ampoules/containers which will cover two phases ( forward direction & reverse direction) of 10 minutes each.
- The actual vacuum in the vacuum leak test machine should be (NLT -550 mmhg). On this value, the leak container/ampoules will be partly or fully emptied out.
- On startup of the vacuum cycle, the vacuum pump start & create the vacuum in the chamber up to the set limit in HMI & as the vacuum reaches to set limit, the first “forward direction cycle” will run for 10 minutes & vacuum will hold in the chamber up to set limit (550-600 mmHg).
- After 10 minutes vacuum will release & the chamber will start rotating in the reverse direction up to 180º & “forward direction cycle” will end.
- Then in the reverse direction, the second reverse direction cycle will start for 10 minutes & again vacuum will hold in the chamber up to the set limit (550-600 mmHg).
- After completion of the “reverse direction cycle” of 10 minutes chamber reaches its original position & chamber vacuum release & one vacuum leak test cycle will be complete.
- On completion of the vacuum cycle collect cycle printout of each lot cycle & attached in BMR.
- Open the chamber & unload the trays & check each container for leakage.
- Drain out the leak container solution in the chamber by opening the chamber bottom drain valve.
- Load a further lot of ampoules & follow the same steps.
- Separate out each lot rejection containing total empty, half empty containers, and fewer volume containers in red colour rejection box, count them & mention them in BMR & keep the good ampoules in by affixing the status label “Ready for visual inspection”.
After completion of one batch vacuum cycle switch off the machine, clean the chamber with purified water & rinse with the bottom drain valve in the drain to avoid any previous product traces.
- Get the line clearance from QA & run another batch cycle.
- Maintain the record in the logbook.
- Daily verify the oil level of the vacuum pump.
- Daily check all locks & bolts for proper tightness.
- Every day before starting the operation verify the door gasket for any damage.
- Every month verify the shaft of the leak test chamber & grease it.
- Every three months check the vacuum pump & reservoir.
Vacuum Leak Challenge Test
- To perform the challenge test select 20 ampoules of each size and make a small pinhole with syringe of 22 gauge in 10 ampoules & 24 gauge in 10 ampoules.
- Mark the pinhole ampoules & keep them in between the lot & run the cycle as per the operating procedure.
- On completion, the vacuum cycle production & QA person will verify each all ampoule to challenge the machine to detect the pinhole ampules.
- All the pinhole-marked ampoules should be completely empty/partially empty.
- Run the vacuum leak test cycle & record the observation in the log book.
- Cycle frequency: Any one lot of each batch.
- Vacuum Leak test machine Log Book
- Challenge test of vacuum leak test machine
- SVP: Small Volume Parenteral
- HMI: Human Machine Interface
- PLC: Programmable Logic Control