Document Control:
- Document Number: PQ-BFS-001
- Version: 1.0
- Effective Date: [Insert Date]
- Reviewed By: [Insert Name]
- Approval Date: [Insert Date]
Performance Qualification Protocol for Blow-Fill-Seal Machine
Objective: To validate the performance of the Blow-Fill-Seal (BFS) machine to ensure it meets specified requirements for aseptic filling of IV infusions.
Scope: This protocol applies to the Blow-Fill-Seal machine used in the production area for the aseptic filling of large volume parenterals (LVP) and small volume parenterals (SVP) in bags and bottles.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production: Provide necessary access and support during validation.
Prerequisites:
- Completion of Installation Qualification (IQ) for the BFS machine.
- Training of personnel on the BFS operation and validation procedures.
- Availability of necessary materials and equipment for testing.
Equipment Description:
The Blow-Fill-Seal machine is designed for the aseptic production of containers and is critical for maintaining sterility during the filling process. It operates by blowing, filling, and sealing containers in a controlled environment.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify mold temperature during operation. | Temperature within specified range as per URS. | Temperature logs. |
| PQ-002 | Check fill accuracy for specified volume. | Fill accuracy within ±5% of target volume. | Weight measurement records. |
| PQ-003 | Evaluate sterile zone airflow alarms functionality. | All alarms must trigger correctly within defined limits. | Alarm test records. |
| PQ-004 | Audit trail verification for operation logs. | Complete and accurate audit trail maintained. | Audit trail reports. |
Detailed Test Cases:
Test Case 1: Mold Temperature Verification
Procedure: Monitor the mold temperature during the filling process using calibrated thermocouples. Record the temperature at regular intervals.
Acceptance: The temperature must remain within the specified range of [Insert Range].
Evidence: Temperature logs will be reviewed for compliance.
Test Case 2: Fill Accuracy Assessment
Procedure: Conduct fill accuracy tests by weighing filled containers. Compare the weight against the target volume.
Acceptance: Fill accuracy must be within ±5% of the target volume.
Evidence: Weight measurement records will be maintained and analyzed.
Test Case 3: Airflow Alarm Functionality
Procedure: Simulate airflow disruptions and verify that alarms activate as expected.
Acceptance: All alarms must trigger correctly when airflow deviates from set parameters.
Evidence: Alarm test records will be documented.
Test Case 4: Audit Trail Verification
Procedure: Review the audit trail generated by the BFS machine for completeness and accuracy.
Acceptance: The audit trail must show all operations without gaps or errors.
Evidence: Audit trail reports will be submitted for review.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed, and corrective actions will be implemented as necessary.
Approvals:
This protocol must be approved by the following personnel:
- Validation Manager: ____________________ Date: ___________
- Quality Assurance Manager: ______________ Date: ___________
- Production Manager: ____________________ Date: ___________