Document Control
Document Number: IQ-TSLC-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Installation Qualification Protocol for Terminal Sterilization Load Carts/Racks
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Terminal Sterilization Load Carts/Racks are installed correctly and operate as intended for holding bags/bottles in the autoclave.
Scope
This protocol applies to the Installation Qualification of Terminal Sterilization Load Carts/Racks utilized in the Production area for IV Infusions (LVP/SVP – Bags/Bottles).
Responsibilities
The Validation Team is responsible for executing this protocol, ensuring compliance with regulatory standards, and documenting all findings.
Prerequisites
1. Completion of the equipment installation.
2. Availability of necessary documentation (URS, specifications).
3. Training of personnel on equipment operation.
Equipment Description
Terminal Sterilization Load Carts/Racks are designed to hold IV bags and bottles securely during the autoclave sterilization process, ensuring optimal load configuration and stability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify load configuration stability | Load configuration meets specifications outlined in URS Annex15 | Photographic evidence, configuration logs |
Detailed Test Cases
Test Case ID: IQ-01
Objective: To ensure that the load configuration of the Terminal Sterilization Load Carts/Racks maintains stability during operation.
Procedure: Load the carts/racks with specified weights and configurations, then monitor for stability during sterilization cycles.
Acceptance Criteria: The load configuration must not shift or collapse during the sterilization process.
Evidence: Documented observations, photographs of load configuration pre and post sterilization.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be developed and implemented.
Approvals
Prepared by: ____________________ Date: _______________
Reviewed by: ____________________ Date: _______________
Approved by: ____________________ Date: _______________