Operational Qualification Protocol for Bottle Unscrambler in Solid Dosage Form
Document Control:
- Document Number: OQ-001
- Version: 1.0
- Effective Date: 2023-10-01
- Reviewed by: [Name]
- Approved by: [Name]
Objective:
This protocol aims to establish the operational qualification of the Bottle Unscrambler used in the packaging area for solid dosage forms, ensuring it meets specified performance criteria.
Scope:
This protocol applies to the Bottle Unscrambler located in the Packaging/Primary area and is intended for use in the indirect impact on product quality during the bottle feeding and orientation process.
Responsibilities:
- Validation Team: Conduct the qualification activities and document results.
- Quality Assurance: Review and approve the protocol and results.
- Maintenance Team: Ensure the equipment is maintained and operational prior to testing.
Prerequisites:
- Equipment must be installed and calibrated according to standard operating procedures.
- All personnel involved must be trained on the equipment and validation processes.
Equipment Description:
The Bottle Unscrambler is designed to feed and orient bottles in preparation for filling. It includes speed control, jam sensors, and interlocks to ensure safe and efficient operation.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify operational speed settings. | Speed settings must be within specified limits. | Calibration report. |
| OQ-02 | Test jam sensor functionality. | Jam sensors must trigger alerts appropriately. | Test report. |
| OQ-03 | Check interlock system operation. | Interlocks must prevent operation when not engaged. | Test report. |
Detailed Test Cases:
- Test ID: OQ-01
- Procedure: Adjust the speed settings on the Bottle Unscrambler to the specified operational range.
- Acceptance: Speed must be within ±10% of the target setting.
- Evidence: Documented calibration report showing speed settings.
- Test ID: OQ-02
- Procedure: Simulate a jam condition and verify that the sensor activates the alarm.
- Acceptance: Alarm must activate within 5 seconds of a jam.
- Evidence: Documented test report with time stamps.
- Test ID: OQ-03
- Procedure: Engage and disengage the interlock system while attempting to operate the equipment.
- Acceptance: Equipment must not operate when interlocks are disengaged.
- Evidence: Documented test report showing operational status.
Deviations:
Any deviations from the acceptance criteria must be documented and justified within the final report.
Approvals:
All results and documentation must be reviewed and approved by the Quality Assurance team prior to final acceptance.