Operational qualification protocol of Gelatin Melting Reactor

Operational qualification protocol of Gelatin Melting Reactor

PURPOSE:

To describe the Operational Qualification of 300 L Gelatin Melting Reactor, and 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 the Gelatin Melting Reactor.

RESPONSIBILITIES:

It is the responsibility of the Manufacturer to prepare the 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 concerning Operation Qualification and compile data in coordination with the 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.

CRITICAL FEATURE
Main Panel / Control Panel / MMI  Testing
Power & Communication Failure Recovery Verification
Safety Features verification
Password Security Verification
Stirrer RPM verification

Main Panel / Control Panel / MMI Testing.

Purpose – To verify 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
Turn the Main ON / OFF switch to the ON position. R, Y, B indicator shall glow up. The main screen shall display within 1 minute.
Press the start push button. The start push button shall turn green
Press LOGIN on the screen The keypad shall appear on top of LHS of the screen with a beep sound
Enter correct password The entered password shall display on the screen with a beep sound
Touch enter symbol on the screen and then touch the ‘X’ symbol on the keypad screen The keypad shall disappear with a beep sound
Touch the main menu on the screen The main menu screen shall appear with a beep sound
touch set parameter on screen. The set parameter screen shall display the following parameters with a 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 the screen. Loaded parameters shall save with a beep sound
Touch the main menu on the screen. The main menu screen shall appear with a beep sound
Touch process mode on screen. Process mode screen shall display with a beep sound
touch operator code on the screen. The Keypad screen appears with a beep sound
Enter the operator code and check for max. digit. Max. 6-digit operator shall enter with a beep sound for each entry
Touch cycle on the screen The cycle screen shall display contents with a beep sound :

Ingredient transfer

Heating

Mixing

Cylinder up / down

Touch go in front of the content one after another The respective function shall perform as per loaded parameters

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 the system is running once the power is restored The system is not starting on its own, restart the equipment.

Acceptance criteria –  the equipment stops in a safe and secure condition & Lifted load doesn’t come down by its weight. the equipment should not start on 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
Main Power Shut Down Equipment shall stop in a safe and secure condition.
Main Power Restored Equipment shall not start on its own without user permission
Equipment shall be restarted with NO problem.

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 the operational manual.  Press the emergency switch and try to run the equipment and try to start the equipment.  Lift the Top lid to maximum height and leave it as it is. Press the 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.

The top lid shall not come down by its weight when the emergency switch is pressed.

  • Failsafe Results 
Test Acceptance Criteria
Start the machine as per the operational manual The machine shall start running
Press emergency switch Equipment shall stop in safe and secure condition and a beep alarm shall   sound
Try to start the equipment Equipment shall not start until the emergency alarm has been acknowledged
Acknowledged the alarm and restarted 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 weight during the test period and it shall not lift at the end of the test

Password Security Verification

Purpose – To verify the Password Security of the equipment.

Test equipment – None Required.

Procedure – Operate the equipment as mentioned in the tabular column.

Acceptance Criteria – As mentioned in the tabular column

Test Results –

Test Acceptance Criteria
Press LOGIN on the main screen. The keypad shall appear on top of LHS of the screen with a beep sound
Enter the correct password for the operator level The entered password shall display on the screen with a beep sound and the respective screen shall appear with a beep sound
Touch the main menu on the screen. The main menu screen shall appear with a beep sound
Enter the correct password for supervisor-level The entered password shall display on the screen with a beep sound and the respective screen shall appear with a beep sound
Touch the main menu on the screen. The main menu screen shall appear with a beep sound
Enter the correct password for manager-level The entered password shall display on the screen with a beep sound and the respective screen shall appear with a beep sound
Touch the main menu on the screen. The main menu screen shall appear with a beep sound
Enter an incorrect password. The entered password shall display on the screen with a beep sound
Touch the main menu screen The main menu screen shall not appear

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 the operational manual. Set the RPM on MMI and observe the RPM of the stirrer with the Digital Tachometer (Note down the value in the respective trial column) three times. Continue the procedure for a total ‘3’ times.

Acceptance Criteria – The average RPM of the Gelatin Melting Reactor shall not vary more than ± 5% from the RPM of the 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

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

Operational Qualification Tests Status

The table below lists the tests performed and related results.

Critical Feature

 

Pass / Fail
Pass Fail
Main Panel/Control Panel / MMI Testing
Power & communication Failure Recovery Verification
Safety feature verification
Password Security Verification
Stirrer RPM verification test

LIST OF STANDARD OPERATING PROCEDURES

Description
Operating Procedure of 300 L Gelatin Melting Reactor
Cleaning Procedure of 300 L Gelatin Melting Reactor
Preventive maintenance of 300 L Gelatin Melting Reactor

Data Analysis, Summary of OQ & Recommendations

Note: Any changes made in the system must be recorded in this sheet.

CONCLUSION

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