Performance Qualification Protocol for Leak Test Machine Used in IV Infusions
Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Next Review Date: 2024-10-01
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Leak Test Machine operates as intended and meets the specified acceptance criteria for detecting leaks in IV infusion bags and bottles.
Scope
This protocol applies to the Leak Test Machine used in the Production/QC area for IV infusions (both LVP and SVP) and encompasses all operational and critical parameters.
Responsibilities
The Validation Team is responsible for executing this protocol, while the Quality Assurance (QA) department will oversee the approval process.
Prerequisites
All personnel involved in the execution of this protocol must be trained on the operation of the Leak Test Machine and the applicable SOPs.
Equipment Description
The Leak Test Machine is designed to perform pressure and vacuum tests on IV infusion bags and bottles to identify leaks. It features a sensitivity leak rate audit trail to ensure compliance with validation standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Perform a pressure leak test on a sample bag. | Leak rate must not exceed 0.1 mL/min. | Test report and audit trail. |
| PQ-02 | Perform a vacuum leak test on a sample bottle. | Leak rate must not exceed 0.1 mL/min. | Test report and audit trail. |
Detailed Test Cases
Test Case 1: Pressure Leak Test
1. Set up the Leak Test Machine according to the SOP.
2. Place a sample bag on the machine.
3. Initiate the pressure leak test.
4. Record the leak rate from the audit trail.
5. Compare the recorded leak rate to the acceptance criterion.
Test Case 2: Vacuum Leak Test
1. Set up the Leak Test Machine according to the SOP.
2. Place a sample bottle on the machine.
3. Initiate the vacuum leak test.
4. Record the leak rate from the audit trail.
5. Compare the recorded leak rate to the acceptance criterion.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals
Approved by: [Name, Title]
Date of Approval: [Date]