Document Control
Document ID: OQ-OBWM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Ophthalmic Bottle Washing Machine
Objective: To validate the operational performance of the Ophthalmic Bottle Washing Machine to ensure it meets specified requirements for washing bottles used in sterile eye drops and ointments production.
Scope: This protocol applies to the Ophthalmic Bottle Washing Machine used in the Production area for washing bottles prior to sterilization and filling. It covers the critical parameters and acceptance criteria as defined in the User Requirement Specification (URS) Annex 11.
Responsibilities:
- Validation Team: Execute the qualification protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production: Ensure the equipment is operated according to the validated procedures.
Prerequisites:
- Installation Qualification (IQ) completed.
- Standard Operating Procedures (SOPs) for operation and maintenance available.
- Training records for personnel operating the equipment.
Equipment Description:
The Ophthalmic Bottle Washing Machine is designed to wash bottles used for sterile eye drops and ointments. It utilizes a combination of wash pressure, temperature control, and particulate removal techniques to ensure cleanliness before the sterilization process.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify wash pressure settings. | Pressure within specified range (e.g., 30-50 psi). | PLC log report. |
| OQ-02 | Measure wash temperature. | Temperature within specified range (e.g., 60-80°C). | Temperature log report. |
| OQ-03 | Assess particulate removal efficiency. | Particulate count ≤ specified limit. | Particulate analysis report. |
Detailed Test Cases:
- Test Case OQ-01:
Procedure: Set the wash pressure to the required setting and record the PLC log.
Expected Result: Wash pressure should remain within the specified range.
- Test Case OQ-02:
Procedure: Set the wash temperature and monitor during operation.
Expected Result: Wash temperature should remain within the specified range.
- Test Case OQ-03:
Procedure: Perform a particulate removal test after washing.
Expected Result: Particulate count should be within acceptable limits.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on the validation status. A formal deviation report should be generated if critical parameters are not met.
Approvals: This protocol must be reviewed and approved by the Quality Assurance team before execution. All results must be documented and reviewed post-execution for compliance.
Data Integrity Checks:
- Regular backup of PLC logs to ensure data is not lost.
- Audit trail review to confirm all changes are logged and authorized.
- Periodic checks to ensure temperature and pressure sensors are calibrated and functioning.