OPERATIONAL QUALIFICATION PROTOCOL OF DISPENSING BOOTH
TABLE OF CONTENT
- Purpose
- Scope
- Responsibilities
- Procedure
- Operational qualification tests
- Main Panel / Control Panel Testing
- Power & Communication Failure Recovery Verification
- Air Velocity Test
- HEPA Filter Integrity Test
- Differential Pressure across Filters
- Operational Qualification Tests status
- List of Standard Operating Procedures
- Data Analysis, Summary of OQ & Recommendations
- Amendment record
- Conclusion
- PURPOSE:
To describe the Operational Qualification of Open Fronted Containment Facility, its accessories and to define the specification of the system in order to:
- Ensure that the equipment meets the Operational/Design limits.
- 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 Open Fronted Containment Facility and its accessories to be installed at Pharmaceutical company.
- RESPONSIBILITIES:
- It is the responsibility of the Validation team to prepare and check operational qualification.
- It is the responsibility of the Quality Assurance approves the operational qualification.
- PROCEDURE:
The following requirement / practices apply to Open Fronted Containment Facility Operational Qualification activities:
- To verify the components design parameters.
- Review the preventive maintenance procedures, cleaning procedures and general Operation 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 |
Main Panel/Control Panel Testing | |
Power & Communication Failure Recovery Verification | |
Air Velocity Test | |
HEPA Filter Integrity Test | |
Differential Pressure across Filters |
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 is as per the system design.
- Test equipment –
Not Required.
- Procedure –
Give inputs from various Push buttons & Switches on Control Panel / Main Panel & observe the Response from the machine.
- Acceptance Criteria –
- The equipment will respond as mentioned in the target column of the table given below.
- 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 MCB to ‘ON’ position.
Turn light ‘ON/ OFF’ switch |
Tube lights of Dispensing Area will glow. | |||
Press ON Switch for Equipment | Equipment will start. Differential Pressure across HEPA, Intermediate and Prefilter will rise. | |||
Press green air flow push button | Blower starts. Reading is shown across magnehelic pressure gauge | |||
Press red air flow push button | Blower stops. Reading goes to zero |
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 –
Not 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 minute 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.
- 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 stops in a safe and secure condition. | |||
Main Power Restored | Equipment is not starting of its own without user permission | |||
Equipment can be restarted with NO problems . |
|
- Air Velocity Test
- Rationale –
This test covers testing to determine air velocity and uniformity of air velocity at the work location in a clean air device.
- Test equipment –
Air velocity meter.
- Procedure–
- Switch ON the equipment by pressing ON/OFF button and let the system to stabilized for 5-10 minute.
- Take reading in a plane parallel to and 6 inches downstream of the HEPA filters or the protective grille over the filters.
- Take reading at four corners and centers (Refer Fig.1) for minimum of 10 sec. and note the values in the table.
LC2 | RC2 |
LC1 | RC1 |
Acceptance criteria –
The air velocity must be 90 ± 10 FPM within the uniformity of ± 10%.
- Air Velocity Test Results
Name of Measuring Equipment:
Instrument Sr. No.
Calibration Due Date:
HEPA
Filter No. |
LC1 | LC2 | RC1 | RC2 | C | Mean | Acceptance Criteria
|
Meets Test
(Yes / No) |
Checked By | Date |
Note: Mean = LC1+ LC2 + RC1+ RC2 +C/5
HEPA Filter Integrity Test
- Rationale –
To verify that the filter system is properly installed and leakage has not developed.
- Test equipment –
Aerosol Generator and Photometer
- Procedure–
- Ensure the LAF is running for minimum 1 hour.
- Operate the Aerosol generator as per its operation manual.
- Introduce the aerosol before HEPA at a concentration in the range of 10-100 mg/ m3.
- Hold the Photometer probe about 4-5 cm. away from the filter face or the frame structure.
- Scan the entire downstream face of each filter at a scan rate of 5cm/s (for square probe of 3cm X 3cm) and 15cm2/s for rectangular probe.
- Acceptance criteria –
- Leakage factor is not more than 0.03%.
Note:
Air velocity test should be confirmed before this test.
Replace any HEPA filter leakage with silicone sealant. Eliminate leaks in the gasket frame area by re-tightening the filter hold-down clamps.
- HEPA Filter Integrity Test Result
Name of the Measuring Instrument:
M/C Serial No.
System No.
Room Name
Sr. No. | Terminal No. | DOP1- Cold DOP Charged Before HEPA Filter | DOP 2 – Penetration after HEPA filter |
1 | ST/001-HF01 | 100% | _____% |
2 | ST/001-HF02 | 100% | _____% |
3 | ST/001-HF03 | 100% | _____% |
4 | ST/001-HF04 | 100% | _____% |
- Differential Pressure Test
- Rationale –
To verify the Differential Pressure of filters
- Test equipment –
Megnehelic Pressure Gauge inbuilt with the equipment.
- Procedure–
- Start the equipment as per operational manual and allow the blower to get stabilized for 5-10 minutes.
- Note down differential pressure across Magnehalic Pressure Gauge.
- Acceptance criteria –
- As mention in the test result table.
- Differential Pressure Test Results
Description | Acceptance Criteria | Actual Pressure mmwc | Done By | Remark |
Differential Pressure HEPA Filter | 10-20 |
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 | ||
Main Panel/Control Panel Testing | |||||
Power & Communication Failure Recovery Verification | |||||
Air Velocity Test | |||||
HEPA Filter Integrity Test | |||||
Differential Pressure across Filters |
- LIST OF STANDARD OPERATING PROCEDURES
Sr. No. | Description | SOP No | Verified By | Date |
1 | Operating Procedure of Open Fronted Containment Facility | |||
2 | Cleaning Procedure of Open Fronted Containment Facility | |||
3 | Preventive maintenance of Open Fronted Containment Facility |
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