Document Control:
Document Number: OQ-IBC-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Bin/IBC Washer
Objective: To validate the operational performance of the Bin/IBC Washer used for washing IBC/bin contact parts in accordance with the established acceptance criteria.
Scope: This protocol applies to the operational qualification of the Bin/IBC Washer in the Production/Cleaning area, impacting the direct quality of solid dosage form products.
Responsibilities:
- Validation Team: Execution of the OQ protocol and documentation of results.
- Quality Assurance: Review and approval of the OQ protocol and results.
- Maintenance Team: Ensure equipment is maintained and calibrated prior to OQ execution.
Prerequisites:
- Completion of Installation Qualification (IQ).
- All necessary equipment calibrations and maintenance performed.
- Availability of required cleaning agents and materials.
Equipment Description:
The Bin/IBC Washer is designed to wash IBC/bin contact parts using a combination of wash temperature, time, pressure, and detergent dosing, controlled via a PLC. This equipment is critical for ensuring product quality in solid dosage forms.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify wash temperature settings | Temperature within specified range as per URS Annex11 | Temperature log |
| OQ-002 | Verify wash time settings | Time within specified limits as per URS Annex11 | Time log |
| OQ-003 | Verify wash pressure settings | Pressure within specified range as per URS Annex11 | Pressure log |
| OQ-004 | Verify detergent dosing accuracy | Dosing within specified limits as per URS Annex11 | Dosing log |
| OQ-005 | Verify PLC functionality | PLC operates without errors during wash cycle | PLC log |
Detailed Test Cases:
- Test Case OQ-001: Measure and record the wash temperature. Ensure it meets the specified range.
- Test Case OQ-002: Initiate the wash cycle and record the duration. Confirm it aligns with the defined wash time.
- Test Case OQ-003: Measure the wash pressure during operation. Ensure it falls within the acceptable range.
- Test Case OQ-004: Check the detergent dosing system for accuracy. Confirm the amount dispensed meets the requirements.
- Test Case OQ-005: Monitor the PLC during the wash cycle for any errors. Document the operational status.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be proposed and implemented as necessary.
Approvals:
Prepared By: _____________________ Date: _______________
Approved By: _____________________ Date: _______________