Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Review Date: YYYY-MM-DD
Operational Qualification Protocol for Bin Blender / IBC Blender
Objective: To validate the operational performance of the Bin Blender / IBC Blender to ensure it meets specified requirements and operates within defined parameters.
Scope: This protocol covers the operational qualification of the Bin Blender / IBC Blender used for contained blending of solid dosage forms in the production area.
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ protocol and results.
- Production Team: Provide necessary equipment access and support during testing.
Prerequisites:
- Equipment installed and operational.
- Personnel trained on OQ procedures.
- All necessary documentation available for review.
Equipment Description:
The Bin Blender / IBC Blender is designed for contained blending of solid dosage forms, ensuring uniformity and quality of the final product. The equipment allows for efficient mixing while maintaining a controlled environment.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify RPM settings at various levels. | RPM within specified limits as per URS. | Calibration logs. |
| OQ-001-02 | Check docking seal integrity. | No leaks detected during operation. | Seal integrity test results. |
| OQ-001-03 | Measure blending time. | Blending time within specified limits. | Blending time logs. |
Detailed Test Cases:
- Test Case OQ-001-01:
Procedure: Set the Bin Blender to specified RPM levels (e.g., 10, 20, 30 RPM). Record RPM using calibrated tachometer.
Acceptance Criteria: RPM readings should be within ±5% of set values.
Evidence: Calibration log showing RPM readings. - Test Case OQ-001-02:
Procedure: Operate the blender at full capacity and inspect docking seals for leaks.
Acceptance Criteria: No leaks should be detected.
Evidence: Seal integrity test report. - Test Case OQ-001-03:
Procedure: Blend a standard batch and record the time taken.
Acceptance Criteria: Blending time should not exceed specified limits (as per URS).
Evidence: Blending time documentation.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team. Corrective actions should be implemented as necessary.
Approvals:
- ____________________ – Validation Team Lead
- ____________________ – Quality Assurance Representative