Document Number: OQ-DEP-001
Version: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Operational Qualification Protocol for Depyrogenation Tunnel in Sterile Eye Drop Production
Objective: To validate the operational performance of the Depyrogenation Tunnel used for sterilizing glass containers for ophthalmic products.
Scope: This protocol applies to the Depyrogenation Tunnel situated in the Production area, used for sterilizing and depyrogenating containers for sterile eye drops and ointments.
Responsibilities:
- Validation Team: Ensure all validation activities are performed according to the protocol.
- Production Team: Operate the equipment as per the validated procedures.
- Quality Assurance: Review and approve the validation documentation.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Documentation of equipment calibration and maintenance.
- Personnel trained on the operation of the Depyrogenation Tunnel.
Equipment Description:
The Depyrogenation Tunnel is a dry heat sterilizer designed to sterilize and depyrogenate glass bottles used in ophthalmic formulations. The critical parameters include temperature profile, belt speed, and dwell time, ensuring effective endotoxin reduction.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Temperature Mapping | Temperature profile meets URS Annex15 Annex11 | Temperature log report |
| OQ-02 | Belt Speed Verification | Belt speed within specified range | Belt speed calibration report |
| OQ-03 | Dwell Time Assessment | Dwell time meets URS Annex15 Annex11 | Dwell time log |
| OQ-04 | Endotoxin Testing | Endotoxin levels below acceptable limits | Endotoxin test results |
Detailed Test Cases:
Test Case OQ-01: Temperature Mapping
- Place temperature sensors at critical points in the tunnel.
- Run the tunnel under normal operating conditions.
- Record temperatures at specified intervals.
- Compare recorded data against acceptance criteria.
Test Case OQ-02: Belt Speed Verification
- Calibrate the belt speed using a calibrated tachometer.
- Document the speed settings.
- Ensure the speed is within the specified range.
Test Case OQ-03: Dwell Time Assessment
- Measure dwell time using timers at critical points.
- Ensure dwell time meets the specified requirements.
Test Case OQ-04: Endotoxin Testing
- Collect samples post-sterilization.
- Perform endotoxin testing as per validated procedures.
- Document results and compare against acceptance criteria.
Deviations:
Any deviations from the protocol must be documented and reviewed by the Quality Assurance team. Justifications and corrective actions should be recorded.
Approvals:
By signing below, the undersigned approve this Operational Qualification Protocol.
______________________ [Validation Team Lead]
______________________ [Quality Assurance]