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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

 

  C
                                                   RC2
 

 

LC1

 

RC1

        Fig.1

  • 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

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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