Performance Qualification Protocol for Ophthalmic Bottle Washing Machine
Document ID: PQ-OBWM-001
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the performance of the Ophthalmic Bottle Washing Machine to ensure it meets the defined acceptance criteria for washing bottles prior to sterilization and filling.
Scope
This protocol applies to the Ophthalmic Bottle Washing Machine used in the production area for the manufacturing of sterile eye drops and eye ointments. The validation process will focus on critical parameters impacting product quality.
Responsibilities
The Validation Team is responsible for the execution of this protocol, documentation of results, and ensuring compliance with regulatory requirements. The Quality Assurance (QA) department will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary cleaning agents and materials.
- Training of personnel on the use of the equipment.
Equipment Description
The Ophthalmic Bottle Washing Machine is designed to wash bottles used for sterile eye drops and ointments. It operates using high-pressure water jets and adjustable temperature settings to ensure effective cleaning.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure wash pressure | Pressure within specified range | Pressure logs |
| PQ-02 | Measure wash temperature | Temperature within specified range | Temperature logs |
| PQ-03 | Particulate removal test | No visible particulates post-wash | Visual inspection report |
| PQ-04 | Review PLC logs | Logs indicate normal operation | PLC log reports |
Detailed Test Cases
Test Case PQ-01: Measure Wash Pressure
Procedure: Connect a calibrated pressure gauge to the wash system and record the pressure during operation. Compare with the acceptance criteria.
Acceptance Criteria: The wash pressure must fall within the range of [insert range].
Evidence: Documented pressure log.
Test Case PQ-02: Measure Wash Temperature
Procedure: Use a calibrated thermometer to measure the wash temperature during operation. Ensure it meets the set parameters.
Acceptance Criteria: The wash temperature must be within [insert range].
Evidence: Documented temperature log.
Test Case PQ-03: Particulate Removal Test
Procedure: After washing, inspect the bottles for any visible particulates. Conduct a rinse test if necessary.
Acceptance Criteria: No visible particulates should be present on the bottles.
Evidence: Visual inspection report.
Test Case PQ-04: Review PLC Logs
Procedure: Retrieve and review the PLC logs for any anomalies during the washing cycle.
Acceptance Criteria: Logs must indicate normal operational parameters.
Evidence: PLC log reports.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions implemented where necessary.
Approvals
Prepared by: ___________________________ Date: ___________
Approved by: __________________________ Date: ___________