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Operational Qualification of Vertical Laminar Reverse flow Containment Station

  • PURPOSE:
  • To describe the Operational Qualification of Vertical Laminar Reverse flow Containment Station, 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 will be operationally qualified in accordance with current Good Manufacturing Practices
  • SCOPE:
  • The scope of this document applies to the operational qualification of Vertical Laminar Reverse flow Containment Station.
  • RESPONSIBILITIES:
  • It is the responsibility of the Manufacturer to prepare the operational qualification and identify the test parameters to be studied for qualifying the Vertical Laminar Reverse flow Containment Station operationally.
  • It is the responsibility of the client to check and approve the Operational qualification.
  •  PROCEDURE:
  • The following requirement / practices apply to Vertical Laminar Reverse flow Containment Station 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
5.1 Main Panel/Control Panel Testing
5.2 Power & Communication Failure Recovery Verification
5.3 Air Velocity Test
5.4 HEPA Filter Integrity Test
5.5 Differential Pressure Test across Filters
  • Main Panel / Control Panel Testing.
  • Purpose – To verify that the response of the equipment at the input from various Pushbutton / Switches on control or main panel is 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 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
Main Panels main switch switched ON. Control ON indicating lamp will glow.
Press ON Switch for Tube light Tube light will glow.
Press ON Switch for Equipment Equipment will start. Differential Pressure across HEPA, Intermediate and Prefilter will rise.
  • Conclusion:

 

  • 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–
    • 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 –
    • At step 5.2.3.2 the equipment stops in a safe and secure condition.
    • 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.
  • 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.
  • Conclusion:
  • 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

 

LC1

 

C

RC2

 

RC1

     Fig.1

  • Acceptance criteria –
    • The air velocity must be 90 ± 20 FPM.

 

  • Air Flow Velocity Test Results–
  • Name of Measuring Equipment:
  • Instrument Sr. No.:
  • Calibration Due Date:
HEPA

Filter No.

LC1 LC2 RC1 RC2 C Mean Meets Test

(Yes/No)

Checked By Date
F1
F2
F3
F4
F5
F6
  • Note: Mean = (LC1+ LC2 + RC1+ RC2 +C) / 5
  • Conclusion:    
  • 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 (less then 5% of filter area) 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 F1 100% _____%
2 F2 100% _____%
3 F3 100% _____%
4 F4 100% _____%
5 F5 100% _____%
6 F6 100% _____%
  • Conclusion:
  • Differential Pressure Test Across Filters
  • Rationale – To verify the differential pressure across HEPA, Intermediate and Pre filter.
  • Test equipment – Magnehalic 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 HEPA, Intermediate, Pre filter from respective Magnehalic Pressure Gauge.
  • Acceptance criteria – As mention in the test result table.

 

  • Differential Pressure Test Results
Test Acceptance Criteria Results Meets Test

(Yes / No)

Checked By Date
Differential Pressure Across Prefilter 1-3 mm WG
Differential Pressure Across Intermediate filter 1.5-5 mm WG
Differential Pressure Across HEPA 8-14 mm WG
  • Conclusion:                                                                                                          
  • Operational Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number

 

Critical Feature

 

Pass Fail Deviation Found
Yes No
5.1 Main Panel/Control Panel Testing
5.2 Power & Communication Failure Recovery Verification
5.3 Air Velocity Test
5.4 HEPA Filter Integrity Test
5.5 Differential Pressure Test across Filters

 

  • LIST OF STANDARD OPERATING PROCEDURES
Sr. No. Description SOP No. Verified By Date
1 Operating Procedure of Vertical Laminar Reverse flow Powder Containment Station.
2 Cleaning Procedure of Vertical Laminar Reverse flow Powder Containment Station.
3 Preventive maintenance of Vertical Laminar Reverse flow Powder Containment Station.
  •  Data Analysis, Summary of OQ & Recommendations

 

 

 

  • AMENDMENT RECORD

Sr. No.

Item Name

Remarks

Signature & Date

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