OPERATIONAL QUALIFICATION PROTOCOL OF DISPENSING BOOTH

The sampling booth / Dispensing booth

The sampling booth / Dispensing booth is a purifying System. Unidirectional laminar flow Class ISO 5 (Class100).

The Raw materials and compounds are refilling, weighing, filling, and sampling. It is provided with a high-efficiency HEPA filter, which averts the airborne dusts by down flow of air technique. The unit eliminates powder contamination to protect the operator and the surrounding environment.

The dispensing booth removes powder contamination to protect the operator (user) and the nearby environment and is used for weighing, mixing, and dispensing of powder. The sampling / dispensing booth is the re-circulation of air principle.

The weighing room is one kind of clean equipment used in micro-organism research, pharmaceutical, and scientific experimentation, it can supply single and multi-way airflow, and clean air (HEPA AIR) will be circulated in the working area, the other part will be exhaust outside, it can make the working area negative pressure to prohibit cross population, it can guarantee the working area with high clean grade.

The focus weight room is one kind of specialized working room that is particularly used in specimen (sampling), analysis industry, and weighting, it controls the working area powder to prohibit them off the working room. The sampling / dispensing booth is a special equipment to control the powder floating and protect users (operators) not breathing the user-operated powder (User Safety). The center weight room’s working area will be kept at negative pressure condition, exhaust 10% re-circulated air. The small chamber air in the center weighting room will pass through a three-grade filter system HEPA (a high-efficiency filter will remove 99.99% granules ≥0.3um) to make personal circulation. It controls the powder floating, mixture surplus during the process of powder examination, and mixture filling. It can protect the WORKING environment and USER safety.

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.

  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

  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

• 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.

  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:

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

• 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

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

• AMENDMENT RECORD

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

• CONCLUSION

Prepared by                                                     Reviewed by                                       Approved by

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