Operational Qualification Protocol for De-lumper / Lump Breaker
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Name]
Approved by: [Name]
Objective: To establish the operational qualification of the De-lumper / Lump Breaker to ensure it operates within defined parameters for breaking lumps in powder/granules.
Scope: This protocol applies to the De-lumper / Lump Breaker used in the Production/Sieving area for Solid Dosage Form (OSD) manufacturing processes.
Responsibilities:
- Validation Team: Prepare, execute, and report on the OQ protocol.
- Quality Assurance: Review and approve the protocol and reports.
- Production: Provide support during testing and ensure equipment is available.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All relevant personnel must be trained on equipment operation.
Equipment Description:
The De-lumper / Lump Breaker is designed to break down lumps in powder and granules, ensuring uniformity in particle size for further processing in Solid Dosage Form manufacturing. Key critical parameters include blade speed and torque.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Measure blade speed at various settings. | Blade speed must operate within the range specified in the URS. | Calibration records and speed measurement logs. |
| OQ-02 | Measure torque during operation. | Torque must not exceed limits specified in the URS. | Torque measurement logs and equipment calibration records. |
Detailed Test Cases:
Test Case OQ-01: Blade Speed Measurement
Objective: To verify that the blade speed of the De-lumper operates within the specified range.
Procedure:
1. Start the De-lumper and set it to the lowest speed.
2. Use a tachometer to measure the blade speed.
3. Repeat for all speed settings.
Acceptance Criteria: The measured blade speeds must be within the range specified in the URS.
Expected Outcome: All measurements must meet the acceptance criteria.
Test Case OQ-02: Torque Measurement
Objective: To verify that the torque does not exceed specified limits during operation.
Procedure:
1. Start the De-lumper at a medium speed setting.
2. Use a torque meter to measure the torque during operation.
3. Document the readings.
Acceptance Criteria: Torque must not exceed the limits specified in the URS.
Expected Outcome: All torque measurements must meet the acceptance criteria.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented if necessary.
Approvals:
All test results and deviations must be reviewed and approved by the Quality Assurance team before finalizing the OQ protocol.