SOP FOR OPERATIONAL QUALIFICATION of Soft Gelatin Encapsulation System
- PURPOSE
- To describe the Operational Qualification of Arbes Encapsulation System (CAP-X-8) along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the specification of the system in order to:
- ensure that the equipment meets the Operational/Design limits as per users requirements.
- ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices
- SCOPE
- The scope of this document applies to the operational qualification of Arbes Encapsulation System (CAP-X-8) along with Tumble Dryer and Gravity Feed Pipes.
- RESPONSIBILITIES
- It is the responsibility of the Manufacturer to perform all the tests with respect to Operational Qualification and compiling data in co-ordination with client.
- It is the responsibility of the client to check and approve the Operational Qualification.
- PROCEDURE
- The following requirement / practices apply to Arbes Encapsulation System (CAP-X-8) along with Tumble Dryer and Gravity Feed Pipes Operational Qualification activities:
- To verify the components design parameters.
- Review the preventive maintenance procedures, cleaning procedures and general.
- Operational procedure to ensure that they are comprehensive for reliable performance of the equipment.
- OPERATIONAL QUALIFICATION TESTS
- The table below lists the tests to be performed as part of the Operational Qualification phase.
| TEST NUMBER | CRITICAL FEATURE |
| 1 | Main Panel / Control Panel / MMI Testing |
| 2 | Power & Emergency Failure Recovery Verification |
| 3 | Safety Features Verification |
| 4 | Password Security Verification |
| 5 | Variable RPM Verification |
| 6 | Gravity Feed Pipe Heaters Verification |
- Main Panel / Control Panel / MMI Testing–
- Purpose – To verify that the response of the equipment at the input from various Pushbutton / Switches on control or main panel / MMI is as per the system design.
- Test equipment – None Required.
- Procedure – Give inputs from various Push buttons & Switches on Control Panel / Main Panel / MMI & observe the Response from the machine.
- Acceptance Criteria – The equipment shall respond as mentioned in the target column of the table.Take dry run of the equipment to ensure that all controlling parameters &functions are reproducible.
- Test Results
|
Input |
Target |
Actual |
Test Done by |
Date |
| Turn ON the power supply from service floor | Y, R, B shall turn ON on the control panel | |||
| 1.0 Main Machine | ||||
| Turn ON the main ON/OFF switch
|
RPM meter for die roll shall turn ON.
Mangle roller OFF LED shall turn ON |
|||
| Press machine start push button | Machine shall start running and start push button shall glow green | |||
| Press machine stop push button | Machine shall top running and machine start push button shall turn OFF glowing. | |||
| Press and hold machine inch push button | Machine shall run till inch push button is pressed and hold. | |||
| Reduce compressed air pressure to minimum operating limit and then die roll load push button | Die rolls shall come close to each other.
Die roll push button shall glow green |
|||
| Press die roll unload push button. | Dies rolls shall return back to their original position. | |||
| Turn the segment lifting switch to up position | Segment assembly shall start lifting upward. | |||
| Turn the segment lifting switch to pause position | Segment assembly shall stop lifting upward. | |||
| Turn the segment lifting switch to down position | Segment assembly shall start lifting downward. | |||
| Turn the segment lifting switch to pause position | Segment assembly shall stop lifting downward. | |||
| Turn ON temp. controller for Segment | Temp. Controller of segment shall turn ON.
Segment ON LED shall glow |
|||
| Turn ON ribbon lubrication rotary button | Lubricating oil shall start coming out from ribbon lubricating rollers | |||
| Turn ON the feed pump switch | Lubrication oil supply shall start to sliding plate. | |||
| Turn the conveyor switch forward position | Conveyor shall start running in forward direction | |||
| Turn the conveyor switch stop position | Conveyor shall stop running | |||
| Turn the conveyor switch reverse position | Conveyor shall start running in reverse direction | |||
| Turn the conveyor switch stop position | Conveyor shall stop running | |||
| Turn OFF both temp. controller for Spreader Box | Temp. Controller of Spreader Box shall turn OFF.
Heater ON LED shall turn OFF. |
|||
| Turn OFF temp. controller for Segment | Temp. Controller of segment shall turn OFF.
Segment ON LED shall turn OFF |
|||
| Turn OFF ribbon lubrication rotary button | Lubricating oil shall stop coming out from ribbon lubricating rollers | |||
| Turn OFF the feed pump switch | Lubrication oil supply shall stop to sliding plate. | |||
| 2.0 Tumble Dryer | ||||
| Turn ON the main switch | Blower shall start and MMI shall turn ON | |||
| Turn AUTO / MAN switch to MAN position and press the basket-1 In push button. | Basket-1 In push button shall turn green and basket-1 of tumble dryer shall start rotating in anticlockwise direction. | |||
| Press the red stop push button | Basket-1 In push button shall turn OFF and basket-1 of tumble dryer shall stop rotating. | |||
| Press the basket-1 Out push button. | Basket-1 Out push button shall glow and basket-1 of tumble dryer shall start rotating in clockwise direction. | |||
| Press the red stop push button | Basket-1 In push button shall turn OFF glowing and basket-1 of tumble dryer shall stop rotating. | |||
| Press the basket-2 In push button. | Basket-2 In push button shall turn green and basket-2 of tumble dryer shall start rotating in anticlockwise direction. | |||
| Press the red stop push button | Basket-2 In push button shall turn OFF and basket-2 of tumble dryer shall stop rotating. | |||
| Press the basket-2 Out push button. | Basket-2 Out push button shall glow and basket-2 of tumble dryer shall start rotating in clockwise direction. | |||
| Press the red stop push button | Basket-2 In push button shall turn OFF glowing and basket-2 of tumble dryer shall stop rotating. | |||
| Press the basket-3 In push button. | Basket-3 In push button shall turn green and basket-3 of tumble dryer shall start rotating in anticlockwise direction. | |||
| Press the red stop push button | Basket-3 In push button shall turn OFF and basket-3 of tumble dryer shall stop rotating. | |||
| Press the basket-3 Out push button. | Basket-3 Out push button shall glow and basket-3 of tumble dryer shall start rotating in clockwise direction. | |||
| Press the red stop push button | Basket-3 In push button shall turn OFF glowing and basket-3 of tumble dryer shall stop rotating. | |||
| Turn the conveyor button to forward position | Conveyor shall start running forward direction | |||
| Turn the conveyor stop position | Conveyor shall stop running. | |||
| Turn the conveyor button to reverse position | Conveyor shall start running reverse direction | |||
| Turn the conveyor stop position | Conveyor shall stop running. | |||
| Turn the AUTO / MAN switch to AUTO position and press setting key on MMI | Next screen shall display | |||
| Press F1 key on MMI | Password screen shall display | |||
| Enter the password | Setting mode screen shall display with following contents
Operator Name Operator ID No. Product Name Product ID No. Batch No. |
|||
| Load the Operator Name,
Operator ID No., Product Name, Product ID No. Batch No. |
Loaded details shall display on the screen | |||
| Press Cycle Time key on the MMI | Set Cycle Time screen shall display | |||
| Load the cycle time in min. | Loaded Cycle Time (min.) shall display | |||
| Press process key | Process shall start and it shall terminate automatically after the Set Cycle Time. | |||
| Open the main screen on MMI and press Manual Mode on the MMI | Manual Mode main screen shall display | |||
- Conclusions / Comments:
- PASS FAIL
- Verified By: ________________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Power & Communication Failure Recovery Verification–
- Rationale – To verify that in the event of a power loss or communications failure, the equipmentwill stop in safe condition.
- Test equipment – None Required.
- Procedure for Power and Communication Failure Recovery test – Operate the equipment in automatic mode or as directed in the User Manual. While the equipment is operating, shut down the power to the main control panel. Record if the equipment stops in a safe and secure condition. Wait for 5 minutes then restore power to the equipment. Check whether system is start running once the power is restored The system is not starting of its own, restart the equipment; check the lifting and lowering operation and note any adverse condition.
- Acceptance criteria – the equipment stops in a safe and secure condition & Lifted load doesn’t come down by its own weight. the equipment should not start of its own after the power is restored without user permission .the equipment can be restarted with NO problems or adverse conditions observed while Lifting & Lowering.
- Power and Communication Failure Recovery test results
| Test | Results | Meets Test
(Yes / No) |
Test Done by | Date |
| Main Power Shut Down | Equipment shall stop in a safe and secure condition. | |||
| Main Power Restored | Equipment shall not starting of its own without user permission | |||
| Equipment shall be restarted with NO problems or adverse conditions observed while. |
|
- Conclusions / Comments:
- PASS FAIL
- Verified By: ________________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Safety Feature Verification–
- Purpose – To avoid damage to the operator or property while operating the equipment.
- Test equipment – None Required.
- Procedure – Operate the Machine as per Procedure given in the test column of above table.
- Acceptance Criteria – Machine shall operate as per acceptance criteria column of the above table.
- Failsafe Results –
| Test | Acceptance Criteria | Meets Spec.
(Yes / No) |
Test Done by | Date |
| Operate the machine as per operation manual and press the Emergency button | Machine shall stop in safe mode | |||
| Try to start the machine | Machine shall not start | |||
| Release the Emergency button and try to start the machine | Machine shall start running | |||
| Stop the machine as mentioned in the operation manual | Machine shall stop running | |||
| Operate the Tumble dryer as per operation manual
And press the Emergency button |
Tumble Dryer shall stop running. | |||
| Try to start the tumble dryer | Machine shall not start | |||
| Release the Emergency button and try to start the tumble dryer | Tumble dryer shall start running | |||
| Stop the tumble dryer as mentioned in the operation manual | Tumble dryer shall stop running |
- Conclusions / Comments:
- PASS FAIL
- Verified By: ________________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Password Security Verification-
- Rationale – To verify that in the password security of the Tumble Dryer.
- Test equipment – None Required.
- Procedure– Operate the machine as per procedure mentioned in the test column of the above table
- Acceptance criteria – Machine shall operate as per acceptance criteria column of the above table.
- Password Security Verification Test Results
| Test | Results | Meets Spec.
(Yes / No) |
Sign. / Date |
| Turn the AUTO / MAN switch to AUTO position and press setting key on MMI | Next screen shall display | ||
| Press F1 key on MMI | Password screen shall display |
|
|
| Load the wrong password and press Enter | Next screen shall not display
|
||
| Load the correct password and press Enter | Next screen shall display
|
- Conclusions / Comments:
- PASS FAIL
- Verified By: ________________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Variable RPM verification test
- Propose – To check the capsulator rotation as per set RPM.
- Test equipment – Digital tachometer required.
- Procedure – Operate the machine as per operational manual and observe the RPM of Capsulator. Repeat the Step for 3 time.
- Acceptance Criteria – The average RPM of the capsulator shall not vary more than ± 5% than the set RPM.
- Variable RPM verification test results–
| Set RPM | Acceptance Criteria | Trial-1
No of Revolution |
Trial-2
No of Revolution |
Trial-3
No of Revolution |
Average RPM
|
Test Done by | Date |
| Average RPM should not vary more than ± 5% than the set RPM | |||||||
- Note:
- a) Enter the no of rotation for ‘1’ minutes in the trial –1, 2 & 3 columns.
- b) Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3
- Conclusions / Comments:
- PASS FAIL
- Verified By: ________________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Gravity Feed Pipe Heaters Verification–
- Rationale –To verify the normal functioning of the gravity Feed Pipe Heaters .
- Test equipment – None Required.
- Procedure– Operate the machine as per procedure mentioned in the test column of the above table.
- Acceptance criteria – Machine shall operate as per acceptance criteria column of the above table.
- Main Power Failure Test Results–
| Test | Results | Meets Spec.
(Yes / No) |
Sign. /Date |
| Turn both the heater ON/OFF button to ON position | Both Heaters ON LED shall turn ON and temp. indicator screens of both the heaters shall turn ON | ||
| Adjust the Temp. on both the temp. indicator cum controller | Set temp. shall display on the temp. indicator screens of both the heaters and after reaching the set temp. heaters shall turn OFF automatically and on when temp. will fall down below set temp. heaters shall turn ON automatically |
|
|
| Turn both the heater ON/OFF button to OFF position | Both Heaters ON LED shall turn OFF and temp. indicator screens of both the heaters shall turn OFF |
- Conclusions / Comments:
- PASS FAIL
- Verified By: ________________________ Date: ______________
- Reviewed By: ________________________ Date: ______________
- Operational Qualification Tests Status
- The table below lists the tests performed and related results.
|
Test Number |
Critical Feature | Pass | Fail | Deviation | |
| Yes | No | ||||
| 1 | Main Panel / Control Panel Testing | ||||
| 2 | Verification of Man Machine Interface Screens – MMI | ||||
| 3 | Power & Emergency Failure Recovery Verification | ||||
| 4 | Safety Features Verification | ||||
| 5 | Password Security Verification | ||||
| 6 | Variable RPM Verification | ||||
| 7 | Gravity Feed Pipe Heaters Verification | ||||
- LIST OF STANDARD OPERATING PROCEDURES
| Sr. No. | Description | SOP No. | Verified By | Date |
| 1 | Operating Procedure of Encapsulation Machine (Arbes) and Tumble Dryer | |||
| 2 | Cleaning Procedure of Encapsulation Machine (Arbes) and Tumble Dryer | |||
| 3 | Preventive maintenance of Procedure of Encapsulation Machine (Arbes) and Tumble Dryer |
- Data Analysis , Summary of OQ & Recommendations
- AMENDMENT RECORD
| Sr. No. | Item Name | Remarks | Signature & Date |
- Note: Any changes made in the system must be recorded in this sheet.
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