Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Design Qualification Protocol for Stent Coating Machine
This document outlines the Design Qualification (DQ) protocol for the Stent Coating Machine used in the application of drug-polymer coatings to medical devices.
Objective: To ensure that the Stent Coating Machine is designed and installed in accordance with user requirements and applicable regulations.
Scope: This protocol applies to the Stent Coating Machine (Spray/Dip) utilized in the R&D and Production areas for drug-eluting stents and coated devices.
Responsibilities:
- Validation Team: Oversee the execution of the DQ protocol.
- Quality Assurance: Review and approve the DQ documentation.
- Engineering: Provide technical support and equipment specifications.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Approval of the project plan and validation strategy.
- Availability of the Stent Coating Machine for testing.
Equipment Description: The Stent Coating Machine is designed for the application of drug-polymer coatings on medical devices using spray and dip methods. It is critical for ensuring uniform coating thickness and proper adhesion of the drug-polymer mixture.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify coating thickness uniformity | Uniformity within specified limits | Thickness measurement records |
| T2 | Check spray parameters | Parameters within defined specifications | Spray parameter logs |
| T3 | Record drying time | Drying time within acceptable range | Drying time records |
Detailed Test Cases:
- Test ID: T1
- Procedure: Measure the coating thickness at multiple points on the device.
- Acceptance Criteria: Coating thickness must be uniform within the specified limits.
- Evidence: Documented measurement results.
- Test ID: T2
- Procedure: Monitor and log spray parameters during operation.
- Acceptance Criteria: All parameters must be within defined specifications.
- Evidence: Parameter logs and calibration certificates.
- Test ID: T3
- Procedure: Measure the time taken for the coating to dry after application.
- Acceptance Criteria: Drying time must fall within the acceptable range.
- Evidence: Drying time logs.
Deviations: Any deviations from the acceptance criteria must be documented, with an explanation and a plan for resolution.
Approvals:
- Validation Team Lead: _____________________ Date: __________
- Quality Assurance Manager: _____________________ Date: __________
- Engineering Manager: _____________________ Date: __________
Data Integrity Checks: Ensure that all data recorded during testing is verified for accuracy and completeness. Implement version control for all documentation and logs.