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.

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

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

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 

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 –

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

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.

LIST OF STANDARD OPERATING PROCEDURES

Data Analysis, Summary of OQ & Recommendations

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

CONCLUSION

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