Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Operational Qualification Protocol for Pneumatic Conveying System in Solid Dosage Form Production
Objective: To validate the Pneumatic Conveying System for the transfer of solid dosage forms, ensuring it meets the specified performance criteria as per URS Annex11.
Scope: This protocol applies to the Pneumatic Conveying System used in the Production/Material Transfer area for conveying solid dosage forms via air stream.
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ documentation.
- Production Personnel: Ensure equipment is operational and available for testing.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All necessary equipment and materials must be in place and calibrated.
Equipment Description:
The Pneumatic Conveying System operates on a dilute phase conveying principle, utilizing an air stream to transport solid dosage forms from a pickup point to a receiver. The system is critical for maintaining product integrity during the transfer process.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify airflow velocity at pickup point. | Airflow velocity must be within specified range (e.g., 15-25 m/s). | Flow meter readings, calibration certificates. |
| OQ-001-02 | Evaluate receiver performance. | Receiver must collect 98% of conveyed product. | Weight measurements before and after test. |
| OQ-001-03 | Test PLC functionality for system controls. | PLC must respond accurately to input commands. | PLC logs, screenshots of command inputs and outputs. |
Detailed Test Cases:
- Test Case OQ-001-01: Measure airflow velocity at the pickup point using calibrated flow meter. Document readings and ensure they fall within the specified range.
- Test Case OQ-001-02: Conduct a test run to convey a known quantity of product. Weigh the product before and after the test to verify collection efficiency.
- Test Case OQ-001-03: Simulate various operational scenarios to ensure PLC functions correctly. Document all inputs and outputs for review.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address any issues identified during testing.
Approvals:
- Validated by: ____________________ (Validation Team Lead)
- Date: ____________________
- Approved by: ____________________ (Quality Assurance)
- Date: ____________________
Data Integrity Checks:
- Ensure all data is recorded in validated electronic systems.
- Implement regular audits of data entries and calibration logs.
- Backup all data in accordance with SOPs to prevent loss.