Stent Coating Machine (Spray/Dip) – DQ Protocol

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:

  1. 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.
  2. 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.
  3. 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.
See also  VHP Decontamination Unit (if isolator/RABS) – Qualification Certificate Template

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.

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