Document Control Number: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Drying Oven Used in Coated Devices Production
Objective: To establish documented evidence that the Drying Oven is installed according to the manufacturer’s specifications and is suitable for its intended use in the curing and drying of drug-eluting stents and coated devices.
Scope: This protocol applies to the Installation Qualification of the Drying Oven located in the R&D/Production area, specifically for its application in the production of coated devices.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained and operational.
Prerequisites:
- Completion of equipment purchase and installation.
- Training of personnel on equipment operation and safety.
- Availability of manufacturer’s installation and operation manuals.
Equipment Description:
The Drying Oven is designed to cure and dry coatings applied to drug-eluting stents and other coated devices. It features temperature uniformity, controlled airflow, and data logging capabilities to ensure compliance with critical quality parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against manufacturer’s specifications. | All components must match specifications. | Installation checklist. |
| IQ-02 | Conduct temperature uniformity test. | Temperature variation within ±2°C. | Temperature mapping report. |
| IQ-03 | Verify airflow records. | Airflow meets specified rates. | Airflow measurement logs. |
Detailed Test Cases:
- Test ID: IQ-01
- Procedure: Inspect all installed components against the manufacturer’s installation manual.
- Acceptance Criteria: All components must be present and correctly installed.
- Evidence: Signed installation checklist.
- Test ID: IQ-02
- Procedure: Place temperature sensors at various locations inside the oven and record temperatures.
- Acceptance Criteria: Temperature readings must not exceed ±2°C variation.
- Evidence: Temperature mapping report with documented readings.
- Test ID: IQ-03
- Procedure: Measure airflow using a calibrated anemometer at designated points.
- Acceptance Criteria: Airflow must meet the specified rate as per the URS.
- Evidence: Airflow measurement logs and calibration certificates.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team. A root cause analysis will be conducted to determine corrective actions.
Approvals:
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Prepared By
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Reviewed By
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Approved By