Document Control
Document Number: PQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Performance Qualification Protocol for De-lumper / Lump Breaker
Objective: To validate the performance of the De-lumper / Lump Breaker to ensure it meets the specified acceptance criteria for breaking lumps in powder and granules.
Scope: This protocol applies to the De-lumper / Lump Breaker used in the production area for solid dosage forms.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for assisting in the execution of the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel on equipment operation.
Equipment Description:
The De-lumper / Lump Breaker is designed to reduce the size of lumps in powder and granules, ensuring uniform particle size for further processing. The key critical parameters include blade speed and torque.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001 | Measure blade speed at different settings. | Blade speed must meet specifications as per URS. | Calibration report, speed measurement logs. |
| PQ-002 | Measure torque during operation. | Torque must not exceed defined limits. | Torque measurement logs, operational logs. |
Detailed Test Cases
Test Case 1: Blade Speed Measurement
Objective: To verify that the blade speed is within the specified limits.
Procedure: Set the De-lumper to the first speed setting and record the blade speed using a calibrated tachometer. Repeat for all speed settings.
Acceptance Criteria: Blade speed must fall within the range specified in the URS.
Expected Results: Blade speed measurements should be documented and compared against the URS.
Test Case 2: Torque Measurement
Objective: To ensure that the torque does not exceed defined limits during operation.
Procedure: Operate the De-lumper at maximum load and measure the torque using a calibrated torque meter.
Acceptance Criteria: Torque must not exceed the limits defined in the URS.
Expected Results: Torque measurements should be recorded and reviewed against the acceptance criteria.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report must be submitted to Quality Assurance for review and approval.
Approvals
Prepared By: [Insert Name] – [Insert Title]
Reviewed By: [Insert Name] – [Insert Title]
Approved By: [Insert Name] – [Insert Title]