Document Control:
Document Number: PQ-BB-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Bin Blender / IBC Blender
Objective: To validate the performance of the Bin Blender / IBC Blender used in the production of solid dosage forms, ensuring the equipment meets defined critical parameters and acceptance criteria.
Scope: This protocol covers the performance qualification of the Bin Blender / IBC Blender located in the Production/Blending area, specifically for contained blending processes impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the equipment during testing.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary equipment and materials for testing.
- Training of personnel on equipment operation and safety protocols.
Equipment Description:
The Bin Blender / IBC Blender is designed for contained blending of solid dosage forms, ensuring uniformity and consistency in the final product. The critical parameters to be monitored include RPM, docking seal integrity, and blending time.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify RPM during blending operation. | RPM within specified range as per URS. | Calibration logs and test records. |
| PQ-002 | Assess docking seal integrity. | No leaks observed during blending. | Visual inspection report. |
| PQ-003 | Measure blending time to achieve homogeneity. | Blending time meets URS requirements. | Blending time records. |
Detailed Test Cases:
- Test ID: PQ-001
- Procedure: Start the Bin Blender and set to the specified RPM. Monitor and record RPM during operation.
- Acceptance Criteria: RPM must remain within the specified range as per URS.
- Evidence: Calibration logs and RPM monitoring records must be documented.
- Test ID: PQ-002
- Procedure: Conduct a visual inspection of the docking seal before and after blending.
- Acceptance Criteria: No leaks should be observed during the blending process.
- Evidence: Document visual inspection findings in the report.
- Test ID: PQ-003
- Procedure: Blend a predefined batch and measure the time taken to achieve homogeneity.
- Acceptance Criteria: Blending time must meet the requirements outlined in the URS.
- Evidence: Record blending time and compare against the URS criteria.
Deviations: Any deviations from the established protocol must be documented and reviewed. A formal deviation report must be generated for any critical failures or non-compliance observed during testing.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance: ______________________ Date: __________
- Production Manager: ______________________ Date: __________