Document Control
Document ID: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Bottle Washing/Rinsing Machine
Objective
The objective of this protocol is to establish and document the operational qualification (OQ) of the Bottle Washing/Rinsing Machine used for cleaning bottles prior to filling in the production area.
Scope
This protocol applies to the Bottle Washing/Rinsing Machine used for IV Infusions (LVP/SVP – Bags/Bottles) in the production area. It includes the verification of critical parameters impacting product quality.
Responsibilities
The Quality Assurance team is responsible for the execution and documentation of this protocol. The Production team will provide support during the qualification activities.
Prerequisites
1. Completion of Installation Qualification (IQ) for the Bottle Washing/Rinsing Machine.
2. Availability of all necessary materials and equipment for testing.
3. Training of personnel involved in the OQ execution.
Equipment Description
The Bottle Washing/Rinsing Machine is designed to clean bottles used in IV Infusions, ensuring they are free from contaminants before the filling process. The machine utilizes a rinse pressure system to remove particulates and is equipped with PLC logging capabilities for data integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify rinse pressure settings | Rinse pressure within specified range | Pressure log report |
| OQ-02 | Check for particulate removal efficiency | Particulates removed as per specifications | Visual inspection report |
| OQ-03 | Review PLC logs for data integrity | Logs show no discrepancies | PLC log report |
Detailed Test Cases
Test Case OQ-01: Verify Rinse Pressure Settings
Procedure: Measure the rinse pressure during operation using calibrated gauges. Ensure it is within the specified range of [Insert Range].
Acceptance Criteria: Rinse pressure must be maintained within the specified range.
Test Case OQ-02: Check for Particulate Removal Efficiency
Procedure: Conduct a visual inspection of the bottles post-washing to verify the absence of any particulates.
Acceptance Criteria: No visible particulates should be present on the bottles.
Test Case OQ-03: Review PLC Logs for Data Integrity
Procedure: Extract and review PLC logs for the washing cycle to confirm no discrepancies or errors have occurred.
Acceptance Criteria: All logs should show consistent data without any anomalies.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan shall be developed and implemented as necessary.
Approvals
This protocol must be reviewed and approved by the Quality Assurance Manager and the Production Manager prior to execution.