- Operational Qualification of Ointment Manufacturing Vessel
- PURPOSE:
- To describe the Operational Qualification of Ointment Manufacturing Vessel, 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 Ointment Manufacturing Vessel.
- RESPONSIBILITIES:
- It is the responsibility of the client to check and approve the Operational qualification.
- 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.
- The following requirement / practices apply to Ointment Manufacturing Vessel Operational Qualification activities:
- PROCEDURE:
- 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 |
| 5.1 | Main Panel/Control Panel Testing |
| 5.2 | Power & Communication Failure Recovery Verification |
| 5.3 | Safety Features verification |
| 5.4 | Variable RPM verification test |
- Main Panel / Control Panel 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 | |||
| Set required temperature on Temperature Indicator/Controller by pressing Enter and Up or Down Arrow Keys. | Set temperature shall display by pressing Enter Key. | |||
| Turn OMV steam ON/OFF switch to ON position | Pneumatic valve for steam opens and steam starts flowing to jacket. | |||
| Steam valve cut off | Steam temperature shall not increase set temperature. | |||
| Push Anchor ON button | Anchor shall start rotating | |||
| Rotate Anchor Pot knob in clockwise direction | Anchor RPM shall increase | |||
| Rotate Anchor Pot knob in anticlockwise direction | Anchor RPM shall decrease | |||
| Push Anchor OFF button | Anchor shall stop rotating | |||
| Push Homogenizer ON button
|
Homogenizer pump starts operating | |||
| Homogenizer process timer displays | ||||
| Set Homogenizer Process Time
|
Homogenizer process timer | |||
| Homogenizer process timer | ||||
| Press cylinder DOWN push button. | Cylinder down indicator shall glow up and top lid assembly starts lifting down till cylinder down push in engaged and it shall automatically stops lifting down after reaching to min. height | |||
| Press cylinder motor off push button. | cylinder motor turns off. Cylinder motor ON indicator shall turn off. Ampere reading on digital ampere meter digital indicator shall decrease | |||
| Press mixing on push button. | Main motor shall start and stirrer shall start rotating. Mixing on indicator shall glow up and ampere reading on digital ampere meter digital indicator shall increase | |||
| Press mixing OFF push button. | Main motor shall stop and stirrer shall stop rotating. Mixing on indicator shall turn off and ampere reading on digital ampere meter digital indicator shall decrease |
- Conclusions / Comments:
- 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; check the lifting and lowering operation and note any adverse condition
- Acceptance criteria:
- At step 5.2.3.2 the equipment stops in a safe and secure condition & Lifted load doesn’t come down by its own weight.
- At step 5.2.3.4, the equipment should not start of its own after the power is restored without user permission
- At step 5.2.3.5, 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.
Lifted top lid shall not come down by its own weight. |
|||
| 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 Lifting & Lowering. |
|
- Conclusions / Comments:
- Safety Feature Verification
- Purpose – To avoid damage to the operator or property while operating the equipment.
- Test equipment – None Required.
- Procedure –
- Lift the bunker to maximum height and leave as it is.
- Press emergency switch and try to run the equipment.
- Press stop key when equipment is running and again try to start the
- Open the safety railing and try to start the equipment.
- Run the equipment and open the safety railing.
- Acceptance Criteria –
- Bunker shall not come down by its own weight.
- 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.
- Equipment shall not start when it is not in home position.
- Equipment shall not start when safety railing is open.
- Equipment shall stop when safety railing is opened in between the cycle.
- Failsafe Results –
| Test | Acceptance Criteria | Meets
Spec. (Yes / No) |
Test Done by | Date |
| 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 | |||
| Press the emergency button and try to start the equipment | Equipment shall stop in safe and secure condition when emergency push button is pressed and it shall not start until emergency push button has not been released |
- Conclusions / Comments:
- Variable RPM verification test
- Purpose – To check the Variable RPM of stirrer as per set RPM.
- Test equipment – Digital Tachometer Required.
- Procedure:
- Start the equipment as per operational manual.
- Set the RPM on stirrer controller and observe the RPM of the stirrer with Digital Tachometer (Note down the value in respective trial column).
- Repeat the step no. 5.5.3.2 for 3 times.
- Continue the procedure no: 5.5.3.1 & 5.5.3.3 for totally ‘3’ times.
- Acceptance Criteria – The average RPM of the stirrer shall not vary more than ± 5 % than the set RPM on stirrer controller.
- 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 |
| RPM of the stirrer shall not vary more than ± 5 % than the set RPM on stirrer controller | |||||||
- Note:
- a) Enter the RPM observed in the trial –1, 2 & 3 columns.
- b) Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3
- Conclusions / Comments:
- 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 | ||
| 5.1 | Main Panel/Control Panel Testing | ||||
| 5.2 | Power & communication Failure Recovery Verification | ||||
| 5.3 | Safety feature verification | ||||
| 5.4 | Stirrer RPM verification test | ||||
- LIST OF STANDARD OPERATING PROCEDURES
| Sr. No | Description | SOP No | Verified By | Date |
| 1 | Operating Procedure of Ointment Manufacturing Vessel | |||
| 2 | Cleaning Procedure of Ointment Manufacturing Vessel | |||
| 3 | Preventive maintenance of Ointment Manufacturing Vessel |
- 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
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