Performance Qualification Protocol for Aseptic Filling Machine Used in IV Infusions
Document Control Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Aseptic Filling Machine operates within specified limits to ensure the accurate filling of sterile IV bottles.
Scope
This protocol applies to the Aseptic Filling Machine used in the production area for filling sterile IV bottles, including both large volume parenterals (LVP) and small volume parenterals (SVP).
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with applicable regulations and standards.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the Aseptic Filling Machine.
- Availability of all necessary materials and equipment for testing.
Equipment Description
The Aseptic Filling Machine is designed for the sterile filling of IV bottles. It is equipped with features to ensure precision in fill volume and proper stopper/cap placement.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify fill volume accuracy | Fill volume within ±5% of target | Volume measurement logs |
| PQ-002 | Check stopper/cap placement | 100% of stoppers/caps placed correctly | Visual inspection records |
| PQ-003 | Conduct reject audit trail | All rejects logged and investigated | Audit trail report |
Detailed Test Cases
Test Case 1: Fill Volume Accuracy
Procedure: Fill a set of IV bottles with a predetermined volume and measure the actual volume filled. Repeat for multiple runs.
Acceptance Criteria: The fill volume should be within ±5% of the target volume.
Test Case 2: Stopper/Cap Placement
Procedure: Inspect a sample of filled bottles to verify that the stoppers and caps are placed correctly.
Acceptance Criteria: 100% of inspected bottles should have stoppers and caps placed correctly.
Test Case 3: Reject Audit Trail
Procedure: Review the audit trail for any rejected bottles during the filling process.
Acceptance Criteria: All rejected bottles should be logged and investigated, with no discrepancies.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be taken as necessary.
Approvals
Prepared By: [Preparer Name]
Approved By: [Approver Name]