Document Control
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for Drying Oven in Coated Device Production
Objective: To validate the drying oven utilized in the curing and drying of coatings on drug-eluting stents, ensuring it meets specified requirements for product quality and safety.
Scope: This protocol applies to the drying oven used for coating applications in the R&D and production areas for drug-eluting stents and other coated devices.
Responsibilities:
- Validation Engineer: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the DQ protocol and results.
- Production Team: Provide operational insights and support during testing.
Prerequisites:
- Installation Qualification (IQ) must be completed prior to DQ execution.
- All personnel involved must be trained on the operation of the drying oven.
Equipment Description:
The drying oven is designed for the curing and drying of coatings on drug-eluting stents. It features precise temperature control, uniform airflow, and data logging capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify temperature uniformity across the chamber. | Temperature variance within ±2°C. | Calibration logs, temperature mapping report. |
| T2 | Measure drying time for coatings. | Drying time within specified limits from URS. | Time logs, batch records. |
| T3 | Check airflow records during operation. | Airflow must meet the specified rates. | Airflow measurement logs. |
Detailed Test Cases:
Test Case T1: Temperature Uniformity
- Procedure: Place temperature sensors at various locations inside the oven.
- Execute the drying cycle and record temperatures.
- Analyze temperature data for uniformity.
Test Case T2: Drying Time
- Procedure: Apply coating to stents and initiate the drying cycle.
- Record the time taken for the coating to reach the specified dryness.
- Verify against URS specified limits.
Test Case T3: Airflow Measurement
- Procedure: Measure airflow using appropriate gauges during operation.
- Document airflow rates and verify against specifications.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals:
Prepared by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________
Data Integrity Checks:
- Ensure all data logs are time-stamped and securely stored.
- Implement access controls to prevent unauthorized modifications.
- Regular audits of data integrity to ensure compliance with CSV requirements.