Operational Qualification Protocol for LVP/SVP Compounding Vessel
Document Control Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this protocol is to validate the operational performance of the LVP/SVP Compounding Vessel to ensure it meets specified requirements for preparing bulk infusion solutions.
Scope
This protocol applies to the LVP/SVP Compounding Vessel located in the Production area and is intended for use in the preparation of bulk infusion solutions with direct product impact.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ documentation.
- Production Personnel: Responsible for operating the equipment during testing.
Prerequisites
- Completion of Installation Qualification (IQ) for the LVP/SVP Compounding Vessel.
- Availability of necessary equipment and materials for testing.
- Training of personnel on the operation of the compounding vessel.
Equipment Description
The LVP/SVP Compounding Vessel is a jacketed stainless steel vessel designed for the preparation of large volume parenteral (LVP) and small volume parenteral (SVP) infusion solutions. The vessel includes features for temperature control, agitation, and a PLC for monitoring and control.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify agitation functionality | Agitation meets specified RPM | Agitation log |
| OQ-02 | Check temperature hold time | Temperature maintained within specified range for duration | Temperature log |
| OQ-03 | Review PLC audit trail | All critical parameters logged without discrepancies | PLC audit report |
Detailed Test Cases
Test Case OQ-01: Verify Agitation Functionality
Procedure: Operate the vessel at specified RPM for 15 minutes. Record RPM and assess functionality.
Acceptance Criteria: Agitation must achieve and maintain the specified RPM throughout the test duration.
Evidence: Agitation log will be reviewed for compliance.
Test Case OQ-02: Check Temperature Hold Time
Procedure: Set the vessel to the specified temperature and maintain for the required hold time. Record temperature data.
Acceptance Criteria: Temperature must remain within ±2°C of the target for the entire hold time.
Evidence: Temperature log will be reviewed for compliance.
Test Case OQ-03: Review PLC Audit Trail
Procedure: Access the PLC audit trail and review logs for critical parameters during operation.
Acceptance Criteria: No discrepancies or anomalies in the logged data.
Evidence: PLC audit report will be reviewed for compliance.
Deviations
Any deviations from the defined acceptance criteria must be documented and assessed for impact on the validation process. A corrective action plan should be implemented as necessary.
Approvals
Approved By: ______________________
Date: ______________________
Title: ______________________