Jet Mill / Micronizer – IQ Protocol

Document Control:

Document ID: IQ-001

Version: 1.0

Effective Date: 2023-10-01

Reviewed By: [Name]

Approval Date: [Date]

Installation Qualification Protocol for Jet Mill/Micronizer

Objective: To establish and document the Installation Qualification (IQ) of the Jet Mill/Micronizer to ensure it meets operational and regulatory requirements.

Scope: This protocol applies to the Jet Mill/Micronizer used in the production of solid dosage forms within the Production/Milling area.

Responsibilities:

  • Validation Team: Responsible for executing the IQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
  • Production Team: Responsible for providing access to the equipment and necessary documentation.

Prerequisites:

  • Completion of equipment installation as per manufacturer’s specifications.
  • Availability of necessary documentation including User Requirement Specification (URS).
  • Training of personnel on equipment operation and safety procedures.

Equipment Description:

The Jet Mill/Micronizer is designed for micronization processes in the production of solid dosage forms. It utilizes high-velocity air to reduce particle size effectively.

Test ID Procedure Acceptance Criteria Evidence
IQ-01 Verify air pressure settings. Air pressure must be within specified range as per URS. Calibration records.
IQ-02 Check feed rate settings. Feed rate must meet specifications in URS. Operational logs.
IQ-03 Confirm output Particle Size Distribution (PSD). Output PSD must comply with URS requirements. Test results.

Detailed Test Cases:

  • Test ID: IQ-01
    • Procedure: Measure the air pressure at the inlet using a calibrated pressure gauge.
    • Acceptance Criteria: Air pressure should be within the range specified in the URS.
    • Evidence: Documented calibration records of the pressure gauge.
  • Test ID: IQ-02
    • Procedure: Set the feed rate and verify it using a calibrated flow meter.
    • Acceptance Criteria: Feed rate must be as specified in the URS.
    • Evidence: Operational logs showing feed rate settings.
  • Test ID: IQ-03
    • Procedure: Collect samples of the output and analyze for PSD using a laser diffraction particle size analyzer.
    • Acceptance Criteria: Output PSD must comply with the requirements in the URS.
    • Evidence: Test results documentation.
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Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Validation Team and Quality Assurance.

Approvals:

  • Validation Team Lead: ________________________
  • Quality Assurance Manager: ________________________
  • Production Manager: ________________________

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