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Operational qualification protocol of Gelatin Melting Reactor

  • PURPOSE:
  • To describe the Operational Qualification of 300 L Gelatin Melting Reactor, its accessories and to define the specification of the system in order to:
  • ensure that the equipment meets the Operational/Design limits as per user requirements.
  • ensure that the equipment shall be operationally qualified in accordance with current Good Manufacturing Practices.
  • SCOPE:
  • The scope of this document applies to the operational qualification of 300 L Gelatin Melting Reactor.
  • RESPONSIBILITIES:
  • It is the responsibility of the Manufacturer to prepare Operation Qualification Protocol as per Design Qualification.
  • It is the responsibility of the client to check and approve the Operation Qualification Protocol.
  • It is the responsibility of the Manufacturer to perform all the specifications verification checks and tests with respect to Operation Qualification and compiling data in co-ordination with client.
  • PROCEDURE:
  • The following requirement / practices apply to 300 L Gelatin Melting Reactor 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 & Communication Failure Recovery Verification
3 Safety Features verification
4 Password Security Verification
5 Stirrer RPM verification
  • Main Panel / Control Panel / MMI Testing.
  • Purpose – To verify that the response of the equipment at the input from various. Push button / Switches on control or main panel are as per the system design.
  • Test equipment – None Required.
  • Procedure – Give inputs from various Push buttons & Switches on Control Panel / Main Panel & observe the Response from the machine.
  • Acceptance Criteria – The equipment shall respond as mentioned in the target column of the table given below.
  • Test Results
Test Acceptance Criteria Meets

Spec.

(Yes / No)

Test Done by  

Date

Turn Main ON / OFF switch to ON position. R, Y, B indicator shall glow up. Main screen shall display within 1 min.
Press the start push button. Start push button shall turn green
Press LOGIN on screen Keypad shall appear on top of LHS of screen with a beep sound
Enter correct password Entered password shall display on screen with a beep sound
Touch enter symbol on screen and then touch ‘X’ symbol on keypad screen Keypad shall disappear with a beep sound
Touch main menu on screen Main menu screen shall appear with a beep sound
touch set parameter on screen. Set parameter screen shall display following parameters with beep sound :

– Ingredient transfer stop –

Vacuum valve ( mmHg)

– Heating off temp. (ºC)

– Heating on temp. (ºC)

– Mixing Time (min.)

– Stirrer RPM

– Print Interval (sec.)

Load the parameters and touch accept on screen. Loaded parameters shall save with beep sound
Touch main menu on screen. Main menu screen shall appear with a beep sound
Touch process mode on screen. Process mode screen shall display with beep sound
touch operator code on screen. Keypad screen appears with beep sound
Enter operator code and check for max. digit. Max. 6 digit operator shall enter with beep sound for each entry
Touch cycle on screen Cycle screen shall display with contents with beep sound :

–          Ingredient transfer

–          Heating

–          Mixing

–          Cylinder up / down

Touch go in front of the content one after another Respective function shall perform as per loaded parameters
  • 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 equipment will 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.
  • 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. 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 start of its own without user permission
Equipment shall be restarted with NO problem.  

 

  • 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 – Start the equipment as per operational manual.  Press emergency switch and try to run the equipment and try to start the equipment.  Lift the Top lid to maximum height and leave as it is. Press emergency switch.
  • Acceptance Criteria –
  • Equipment shall stop in safe and secure condition when emergency switch is pressed and it shall not start until emergency alarm has not been acknowledged.
  • Top lid shall not come down by its own weight when emergency switch is pressed.
  • Failsafe Results 
Test Acceptance Criteria Meets

Spec.

(Yes / No)

Test Done by Date
Start the machine as per operational manual Machine shall start running
Press emergency switch Equipment shall stop in safe and secure condition and beep alarm shall   sound
Try to start the equipment Equipment shall not start until emergency alarm has been acknowledged
Acknowledged the alarm and restart the equipment Equipment shall restart
Lift the top lid to its maximum height and leave the equipment as such for half an hour and then try to lift the top lid top lid shall not come down by its own weight during test period and it shall not lift up at the end of test
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Reviewed By:            ________________________            Date:     ______________
  • Password Security Verification
  • Purpose – To verify the Password Security of the equipment.
  • Test equipment – None Required.
  • Procedure – Operate the equipment as mentioned in tabular column.
  • Acceptance Criteria – As mentioned in the tabular column
  • Test Results –
Test Acceptance Criteria Meets

Spec.

(Yes / No)

 

Test Done by

 

Date

Press LOGIN on main screen. Keypad shall appear on top of LHS of screen with a beep sound
Enter correct password for operator level Entered password shall display on screen with a beep sound and respective screen shall appear with a beep sound
Touch main menu on screen. Main menu screen shall appear with a beep sound
Enter correct password for supervisor level Entered password shall display on screen with a beep sound and respective screen shall appear with a beep sound
Touch main menu on screen. Main menu screen shall appear with a beep sound
Enter correct password for manager level Entered password shall display on screen with a beep sound and respective screen shall appear with a beep sound
Touch main menu on screen. Main menu screen shall appear with a beep sound
Enter incorrect password. Entered password shall display on screen with a beep sound
Touch main menu screen Main menu screen shall not appear
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Reviewed By:  ________________________            Date:     ______________
  • Stirrer RPM verification test
  • Purpose – To check the stirrer RPM as per set RPM.
  • Test equipment – Digital Tachometer Required.
  • Procedure – Set the equipment as per operational manual. Set the RPM on MMI and observe the RPM of the stirrer with Digital Tachometer (Note down the value in respective trial column) for three times. Continue the procedure for totally ‘3’ times.
  • Acceptance Criteria – The average RPM of the Gelatin Melting Reactor shall not vary more than ± 5% than the RPM of machine design.
  • Stirrer 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 shall not vary more than ±5% of the set RPM
  • Note:
  1. a) Enter the observed RPM in the trial –1, 2 & 3 columns.
  2. b) Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3
  • 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 Found
Pass Fail Yes No
1 Main Panel/Control Panel / MMI Testing
2 Power & communication Failure Recovery Verification
3 Safety feature verification
4 Password Security Verification
5 Stirrer RPM verification test
  • LIST OF STANDARD OPERATING PROCEDURES
Sr. No. Description SOP No. Verified By Date
1 Operating Procedure of 300 L Gelatin Melting Reactor
2 Cleaning Procedure of 300 L Gelatin Melting Reactor
3 Preventive maintenance of 300 L Gelatin Melting Reactor
  • 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.
  • CONCLUSION
  • Prepared by                                      Reviewed By                                               Approved by

 

 

 

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