Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed by: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Bag Washing / Blow-off Station
Objective: To validate the performance of the Bag Washing / Blow-off Station used for removing particulates from IV infusion bags to ensure compliance with regulatory standards.
Scope: This protocol applies to the Bag Washing / Blow-off Station located in the Production area, specifically for the validation of equipment used in the cleaning process of IV infusion bags.
Responsibilities:
- Validation Team: Execute and document the qualification protocol.
- Quality Assurance: Review and approve all validation documentation.
- Production Staff: Ensure equipment is maintained and operated according to SOPs.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of necessary materials and equipment.
- Trained personnel on equipment operation.
Equipment Description: The Bag Washing / Blow-off Station is designed to remove particulates from IV infusion bags using filtered air pressure and blow-off mechanisms. The equipment features a PLC for monitoring and controlling the washing process.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify air pressure filter integrity. | Air pressure must be within specified range. | Calibration logs and pressure readings. |
| OQ-02 | Review PLC logs for operational consistency. | PLC logs must show no errors during operation. | PLC log report. |
Detailed Test Cases:
Test Case OQ-01: Verify Air Pressure Filter Integrity
Objective: Ensure that the air pressure filter is functioning correctly to remove particulates.
Procedure: Measure the air pressure at the outlet of the filter using a calibrated manometer. Compare readings with the manufacturer’s specifications.
Acceptance Criteria: Air pressure must be within the specified range of [Insert Range].
Evidence: Documented pressure readings and calibration certificates.
Test Case OQ-02: Review PLC Logs for Operational Consistency
Objective: Confirm that the PLC controls are functioning without errors during the washing process.
Procedure: Retrieve and review the PLC logs from the last three operational cycles. Identify any error codes or anomalies.
Acceptance Criteria: PLC logs must show no errors during operation.
Evidence: Printed PLC log reports.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. Corrective actions must be initiated as required.
Approvals:
_________________________
Validation Team Lead
_________________________
Quality Assurance Manager