Cleaning, Operation & monitoring of Vacuum leak test machine

Cleaning, Operation & monitoring of Vacuum leak test machine

PURPOSE

To lay down the procedure for cleaning, operation & monitoring of vacuum leak test Machine.

SCOPE                                   

This SOP is applicable for cleaning, operation & monitoring of vacuum leak test machine at SVP manufacturing facility

Vacuum Leak Test Machine

REFERENCE(S) & ATTACHMENTS

References

User manual of Vacuum Leak Test Machine

Attachments

Attachment-I     Vacuum Leak test machine Log Book

Attachment-II     Challenge test of Vacuum Leak Test

RESPONSIBILITY

Production  Person:

To verify that employees are trained before performing or operation any task relevant to this SOP.

To Maintained the record.

Production Head:

To ensure the compliance of SOP.

Quality Assurance Persons

To verify that all the instructions are followed properly as per the given SOP.

To ensure implement of the SOP.

DEFINITION & ABBREVIATION(S)

Definition

 Leak Test : Leak test is the process to detect the weak part of body or joints in the container by means of  vacuum. This process is carried out in the vacuum chamber with an adjustable process cycle time & a vacuum pump evacuate the test chamber & test container simultaneously.

 Abbreviations

C.C. No. : Change Control Number

IPA  :  Iso Propyl Alcohol

BMR :Batch Manufacturing Record

HMI : Human Machine Interface

PLC : Programmable Logic Control

NLT : Not Less Than

PROCEDURE

Equipment Description: Vacuum leak test chamber is a ss 304 square/rectangular shape equipment, having one end fix & other door in front fitted on hinges with 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 heavy duty rectangular pipe frame on two sides. It has provided side shaft for rotation on stand. Through one of the mounting shaft, vacuum line is connected with vacuum pump. It is equipped with touch screen HMI with PLC to set the programme & vacuum retention in the chamber. Chamber rotate through mechanically “thro” on rotation of 180º in one direction & return to original position(one cycle). It has provided one vacuum gauge on the face of front door.

Cleaning

Before start operation, clean the S.S chamber properly  with IPA 70% solution.

Clean all the trays with IPA 70% solution and lint free clothes.

Clean outer ss body of vacuum leak test machine with IPA 70% solution.

 Check Points

Check the vacuum leak test area is properly clean.

Check vacuum leak test machine is properly clean from inside as well outside.

Check there should be on other or previous product ampoules should be there in the area and vacuum leak test chamber.

Check and verify that vacuum gauge is properly calibrated.

Cheek the door gasket of the chamber is not damage or torn, and  is properly grease.

Check the level of vacuum pump oil it should be sufficient before operation.

Check the HMI/PLC of the vacuum leak test machine is properly working.

Check the vacuum release valve, drain valve of chamber is working properly.

Check 3 phase supply of 415 V AC 3phase supply is available.

Operation

 After getting line clearance from QA, open the vacuum leak test chamber.

Arrange the ampoules/ containers/cassettes (10 ml, 20 ml, 30 ml) vertically in ss perforated trays as per the loading pattern.

Load 5 trays in each lot as per as per following loading pattern.

Close the front door of chamber & tightened with the locks.

Check the emergency switch is in release position.

Switch “ON” the “MAINS” electrical supply of leak test machine.

Then switch “ON” the control panel & HMI will start & home screen will display.

Go to the “SET PARAMETER” on the home screen & enter password “303” & go the “SET PARAMETER 1”.

Check the machine parameter (Vacuum pressure, forward hold time, reverse hold time, process end pressure, print internal)  with “SET PARAMETER 1”.

After verifying all set parameter in “SET PARAMETER 1” go to the “SET PARAMETER 2”.

Enter the batch detail (Operator name, product name, batch no., lot no., load quantity).

After entry all detail check the connectivity of 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 red colour “STOP” icon on HMI & cycle will start automatically & after completion of cycle up to set time cycle will be stop.

In “MANUAL MODE” press red colour “AUTO” icon and it will turn in to 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 vacuum leak test machine is fixed 20 minutes for all type of ampoules & containers which will cover in two vacuum phase of 10 minutes each.

Actual vacuum in 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 vacuum cycle, the vacuum pump start & create the vacuum in chamber up to set limit in HMI &  as the vacuum reach up to set limit, first forward direction cycle will run for 10 minutes & vacuum will hold in the chamber up to set limit (NLT -550 mmhg).

After 10 minutes vacuum will release & chamber will start rotating in reverse direction up to 180º & forward cycle will be end.

Then in reverse direction, second reverse direction cycle will start for 10 minutes & again vacuum will hold in chamber up to set limit (NLT -550 mmhg).

After completion of reverse cycle of 10 minutes chamber reaches to his original position & chamber vacuum release & one vacuum leak test cycle will be complete.

On completion of vacuum cycle collect cycle print out of cycle & attached in BMR.

Open the chamber & unload the trays & check each container for leakage.

Drain out the leak container solution in chamber by opening the chamber bottom drain valve.

Load further lot of ampoules & follow the same steps.

Separate out each lot rejection containing total empty, half empty container, less volume containers in red colour rejection box, count them & mention in BMR & good ampoules transfer for visual inspection.

After completion of complete batch vacuum cycle switch off the machine, clean the chamber with purified water & rinse with bottom drain valve in drain to avoid any previous product traces.

Get the line clearance from QA & run another batch cycle.

Maintain the record in the log book.

Safety & precautions

Never spray any disinfectant directly on HMI.

Don’t open the lock of chamber while it is in operation.

Don’t run the vacuum pump without oil.

Don’t stand near to the machine while it is on rotation.

After completion of days operation switch off the mains of machine.

Maintenance

Daily verify the oil level of vacuum pump.

Daily check all locks & bolts for proper tightness.

Every day before start the operation verify the door gasket for any damage.

Every month verify the shaft of leak test chamber & grease it.

Every three months check the vacuum pump & reservoir.

Vacuum Leak Challenge Test

Take 100 cassette of good (already leak tested) filled & sealed ampoule.

Out of them select 20 cassettes of ampoule and make a small pinhole with syringe (22 gauge/23 gauge/24 gauge) in each cassette .

Mark the pin hole ampoules & keep in between the lot &  run the cycle as per the operating procedure.

On completion the vacuum cycle production & QA person will verify each all ampoules to challenge the machine to detect the pin hole ampules.

All the pinhole marked ampoules should be complete empty/partial empty.

Run three cycle & record the observation in attachment-II.

Frequency: Quarterly.

 Attachment-I

VACUUM LEAK TEST MACHINE LOG BOOK

Date /Product /Batch No. /Lot (No./Qty.)/Cycle Time (Start/End )/Vacuum press.(NLT__________mm Hg)/Done by/Checked by

Attachment-II

CHALLENGE TEST OF VACUUM LESK TEST MACHINE

Product Name & Batch No. —————————— Date:——————–

(A) Total Cassette of ampoules

 (B) Ampoules per cassette

(C) Total Ampoules for leak test challenge

(D)   Syringe gauge size – 22 gauge/23 gauge/24 gauge

(E) No. of ampoules with pinhole

(F) Leaked ampoules detected after vacuum leak test D x 100 / C =_____%

(G) Observed Rejected Ampoules in percentage (NLT 100%)

(H) Result (Pass/Fail )

Frequency : Quarterly