Document Control:
Document Number: IQ-TS-AUT-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Installation Qualification Protocol for Terminal Sterilization Autoclave
Objective: To establish and document the installation qualification of the Terminal Sterilization Autoclave used for the terminal sterilization of filled units in IV Infusions production.
Scope: This protocol applies to the Terminal Sterilization Autoclave located in the Production area, intended for the sterilization of LVP/SVP bags and bottles. It covers the validation of critical parameters to ensure compliance with applicable regulatory requirements.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for the upkeep and calibration of the autoclave.
Prerequisites:
- Installation of the Terminal Sterilization Autoclave completed.
- All utilities (water, steam, electrical) are connected and operational.
- Staff trained on the operation of the autoclave.
Equipment Description:
The Terminal Sterilization Autoclave is designed for the terminal sterilization of filled LVP/SVP units. It features advanced controls for F0 mapping, load patterns, venting cycle control, and an audit trail for compliance tracking.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-1 | Verify installation and utility connections | All connections are secure and functional | Installation checklist |
| IQ-2 | Check calibration of critical parameters | Parameters within specified limits | Calibration certificates |
| IQ-3 | Conduct F0 mapping | F0 values meet defined specifications | Mapping report |
| IQ-4 | Test venting cycle control | Venting cycle operates as per protocol | Cycle log |
| IQ-5 | Review audit trail functionality | Audit trail captures all critical operations | Audit trail report |
Detailed Test Cases:
- Test ID: IQ-1: Verify all utility connections (water, steam, electrical) are properly installed and functional.
- Test ID: IQ-2: Check calibration of temperature and pressure sensors against calibrated standards.
- Test ID: IQ-3: Perform F0 mapping using biological indicators to ensure sterilization effectiveness.
- Test ID: IQ-4: Validate the venting cycle by monitoring the pressure changes during operation.
- Test ID: IQ-5: Ensure the audit trail captures all actions taken during the sterilization process.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed for any critical deviations identified during the IQ process.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Quality Assurance)
- ____________________ (Maintenance Supervisor)