Document ID: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Terminal Sterilization Load Carts/Racks
Objective: To validate the operational performance of Terminal Sterilization Load Carts/Racks used in the production of IV Infusions.
Scope: This protocol applies to the Operational Qualification of Load Carts/Racks utilized for holding bags and bottles in the autoclave process within the Production area.
Responsibilities:
- Validation Team: Responsible for executing the qualification protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Staff: Responsible for the proper use of the equipment during the qualification process.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary equipment and materials.
- Training of personnel on the use of the load carts/racks.
Equipment Description:
The Terminal Sterilization Load Carts/Racks are designed to hold IV infusion bags and bottles during the autoclave sterilization process. They are constructed from stainless steel to ensure durability and compliance with sterilization requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify load configuration stability during sterilization cycles. | Load configuration must maintain stability without shifting or collapsing. | Photographic evidence and observation logs. |
| OQ-001-02 | Check the integrity of racks under maximum load conditions. | Racks must not deform or show signs of failure. | Visual inspection reports. |
Detailed Test Cases:
- Test Case OQ-001-01:
- Load the cart with bags/bottles as per the defined configuration.
- Run the sterilization cycle in the autoclave.
- Document any shifts or collapses during the cycle.
- Test Case OQ-001-02:
- Load the maximum capacity of racks with bags/bottles.
- Visually inspect the racks before and after the sterilization cycle.
- Document any deformation or failure.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address any identified issues.
Approvals:
- Validation Team Lead: _____________________ Date: ___________
- Quality Assurance Manager: ________________ Date: ___________