Document Control:
Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Performance Qualification Protocol for Aseptic Filling Machine in IV Infusions
Meta Description: This document outlines the Performance Qualification protocol for the Aseptic Filling Machine used in IV Infusions, ensuring compliance with URS Annex1 and Annex11.
Tags: Performance Qualification, Equipment Validation, Aseptic Filling Machine, IV Infusions, PQ Protocol
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Aseptic Filling Machine for IV Bags operates within specified limits and meets all acceptance criteria as defined in the User Requirements Specification (URS), Annex 1, and Annex 11.
Scope
This protocol applies to the Aseptic Filling Machine used for filling sterile IV bags in the production area. It encompasses all critical aspects of the filling process, including fill volume accuracy, seal parameters, alarms, and audit trail.
Responsibilities
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ protocol and results.
- Production Team: Ensure the Aseptic Filling Machine is set up and maintained according to standard operating procedures.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Aseptic Filling Machine.
- Availability of all necessary materials and equipment for testing.
Equipment Description
The Aseptic Filling Machine is designed to fill sterile IV bags with a specified volume of liquid. It includes features for maintaining sterility, monitoring fill volume accuracy, and ensuring proper sealing of bags.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify fill volume accuracy | Within ± 5% of target volume | Calibration report, measurement logs |
| PQ-02 | Check seal integrity | No leaks observed | Seal test results |
| PQ-03 | Monitor alarm functionality | All alarms function as expected | Alarm logs |
| PQ-04 | Audit trail verification | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases
Test Case 1: Fill Volume Accuracy
Objective: To ensure the fill volume is accurate.
Procedure: Fill a set of bags with a predetermined volume and measure the actual volume.
Acceptance Criteria: The measured volume must be within ± 5% of the target volume.
Data Integrity Check: Verify calibration status of measuring devices before testing.
Test Case 2: Seal Integrity
Objective: To confirm that the seals on the bags are intact.
Procedure: Perform a visual inspection and pressure test on filled bags.
Acceptance Criteria: No leaks should be observed.
Data Integrity Check: Document seal test results and compare against historical data.
Test Case 3: Alarm Functionality
Objective: To verify that all alarms function correctly.
Procedure: Simulate alarm conditions and check response.
Acceptance Criteria: All alarms must activate as expected.
Data Integrity Check: Review alarm logs for accuracy and completeness.
Test Case 4: Audit Trail Verification
Objective: To ensure the audit trail is complete and accurate.
Procedure: Review the audit trail generated during the filling process.
Acceptance Criteria: The audit trail must be complete and without discrepancies.
Data Integrity Check: Cross-reference audit trail against operation logs.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be established to address any identified issues.
Approvals
Prepared by: ____________________
Date: ____________________
Reviewed by: ____________________
Date: ____________________
Approved by: ____________________
Date: ____________________