Performance Qualification Protocol for Bottle Washing/Rinsing Machine
Document Control:
Document Number: PQ-001
Version: 1.0
Date: 2023-10-01
Prepared By: Validation Team
Approved By: Quality Assurance
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Bottle Washing/Rinsing Machine consistently operates within specified parameters to ensure the cleanliness of bottles prior to filling, thereby maintaining product integrity and compliance with regulatory requirements.
Scope
This protocol applies to the Bottle Washing/Rinsing Machine used in the production area for the cleaning of IV infusion bottles (both LVP and SVP) before filling. This document covers the qualification activities necessary to ensure the equipment meets the defined acceptance criteria.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for operating the equipment as per SOPs during qualification.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment for testing.
- Training of personnel on the operation of the Bottle Washing/Rinsing Machine.
Equipment Description
The Bottle Washing/Rinsing Machine is designed to clean LVP and SVP bottles using a combination of water rinse and air drying. The machine operates under controlled conditions to ensure effective particulate removal and meets the criticality requirements outlined in the User Requirements Specification (URS) Annex 11.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001 | Verify rinse pressure | Rinse pressure within specified range | PLC logs |
| PQ-002 | Particulate removal test | No visible particulates in bottles | Visual inspection report |
Detailed Test Cases
Test Case 1: Rinse Pressure Verification
Objective: Ensure that the rinse pressure is within the specified range.
Procedure: Monitor the rinse pressure through the PLC during a complete wash cycle and record the values.
Acceptance Criteria: Rinse pressure must be within the range of 30-50 psi.
Evidence: PLC logs demonstrating pressure readings throughout the cycle.
Test Case 2: Particulate Removal Test
Objective: Confirm that no visible particulates remain in the bottles post-wash.
Procedure: Conduct a visual inspection of 10 randomly selected bottles after the wash cycle.
Acceptance Criteria: No visible particulates should be present in any of the inspected bottles.
Evidence: Visual inspection report documenting the findings.
Deviations
Any deviations from the established acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and appropriate corrective actions must be implemented.
Approvals
Prepared By: ______________________ (Validation Team)
Date: ______________________
Approved By: ______________________ (Quality Assurance)
Date: ______________________
Data Integrity Checks
During the PQ, the following data integrity checks will be performed:
- Regular review of PLC logs for consistency and accuracy.
- Cross-verification of visual inspection reports against actual bottle conditions.
- Backup of all electronic records in compliance with data integrity standards.