Document Control:
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Terminal Sterilization Autoclave in IV Infusions
Meta Description: This document outlines the Performance Qualification Protocol for the Terminal Sterilization Autoclave used in the production of IV infusions (LVP/SVP).
Tags: Equipment Validation, Performance Qualification, Terminal Sterilization, Autoclave, IV Infusions
Objective
The objective of this protocol is to establish and document the performance qualification of the Terminal Sterilization Autoclave used for the terminal sterilization of filled units in the production of IV infusions.
Scope
This protocol applies to the Terminal Sterilization Autoclave utilized in the production area for the terminal sterilization of large volume parenterals (LVP) and small volume parenterals (SVP) in bags and bottles.
Responsibilities
The following personnel are responsible for the execution and documentation of this protocol:
- Validation Team: Execute the PQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Ensure equipment is prepared and maintained for testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
- Availability of necessary equipment and materials for testing.
- Training of personnel involved in the PQ process.
Equipment Description
The Terminal Sterilization Autoclave is designed to ensure the effective terminal sterilization of filled IV infusion units. Key features include:
- F0 mapping load patterns
- Venting cycle control
- Audit trail capabilities
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Conduct F0 mapping of load patterns | F0 values meet defined specifications | Mapping report |
| PQ-002 | Verify venting cycle control | Venting completed as per specifications | Cycle control records |
| PQ-003 | Audit trail verification | Audit trail is complete and accurate | Audit log report |
Detailed Test Cases
Test Case 1: F0 Mapping Load Patterns
Conduct F0 mapping to verify that the sterilization process achieves the required lethality for all load configurations. Data will be collected and analyzed to confirm compliance with the acceptance criteria.
Test Case 2: Venting Cycle Control
Verify that the venting cycle operates within the defined parameters. Document the venting times and ensure compliance with the specifications outlined in the URS.
Test Case 3: Audit Trail Verification
Review the audit trail generated by the autoclave to ensure all actions are recorded accurately and completely. Any discrepancies must be addressed and documented.
Deviations
Any deviations from the protocol must be documented, including a description of the deviation, potential impact, and corrective actions taken.
Approvals
Prepared by: [Name] – Validation Team
Reviewed by: [Name] – Quality Assurance
Approved by: [Name] – Production Manager