Document Control Number: DQ-ED-001
Version: 1.0
Effective Date: 2023-10-01
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Design Qualification Protocol for Depyrogenation Tunnel in Ophthalmics Equipment Validation
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Depyrogenation Tunnel operates within the specified parameters to effectively sterilize and depyrogenate glass bottles used in the production of sterile ophthalmic products.
Scope
This protocol applies to the Depyrogenation Tunnel utilized in the production area for the sterilization of containers intended for sterile eye drops and eye ointments. It encompasses the validation of critical parameters such as temperature profile, belt speed, dwell time, and endotoxin reduction.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for operating the Depyrogenation Tunnel as per the validated procedures.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ execution.
- Availability of all necessary equipment and materials for testing.
Equipment Description
The Depyrogenation Tunnel is a dry heat sterilizer designed to sterilize and depyrogenate glass bottles used for ophthalmic products. The equipment operates by circulating hot air to achieve the required temperature profile for effective sterilization.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Temperature Mapping | Temperature must reach 250°C for a minimum of 30 minutes. | Temperature log and printouts. |
| DQ-02 | Belt Speed Verification | Belt speed must be consistent at 5 m/min. | Belt speed calibration report. |
| DQ-03 | Dwell Time Assessment | Dwell time must be at least 10 minutes at sterilization temperature. | Dwell time recording and analysis. |
| DQ-04 | Endotoxin Reduction Test | Endotoxin levels must be reduced to below 0.25 EU/mL. | Endotoxin test results. |
Detailed Test Cases
Test Case DQ-01: Temperature Mapping
Using calibrated thermocouples, map the temperature across the length of the tunnel. Ensure that all areas reach the specified temperature for the defined duration.
Test Case DQ-02: Belt Speed Verification
Measure the belt speed using a calibrated tachometer to ensure it operates at the specified speed consistently throughout the test.
Test Case DQ-03: Dwell Time Assessment
Monitor the dwell time of containers as they pass through the tunnel to ensure compliance with the defined parameters.
Test Case DQ-04: Endotoxin Reduction Test
Conduct endotoxin testing on samples taken from the output of the tunnel to confirm compliance with acceptance criteria.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and approved through the change control process.
Approvals
Document must be approved by Quality Assurance and validated by the Validation Team before implementation.