Pulse Oximeter Manufacturing Transfer

Background

A medical device manufacturer from the Fortune 500 list hired ECI to support the production transfer of Pulse Oximeter SpO2 devices from Germany and India to their Costa Rica site, during the early stages of the COVID-19 pandemic. Because the transfer project involved contract manufactured devices, limited production information was available to support process development, making it a challenging task. The transfer project required strong process development stages to ensure the end-to-end process was successful.

Additionally, the project was developed during the pandemic, which increased the demand for the SpO2 sensors. Five production lines were to be validated in a Costa Rica facility in accordance with ISO 13485 and FDA Food and Drug Administration requirements, the required Quality Management System elements including several documents such as a Master Validation Plan, Process Failure Mode Effects Analysis, all validations, and transfer project report.

Approach and Solution

An ECI team of four (4) engineering consultants led by a senior project manager were engaged to support the project. The first task was to complete a due diligence assessment on the necessary steps to complete the Master Validation Plan. This assessment identified documents impacted or the required creation of new documentation.

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Comprehensive Action

ECI engineers worked collaboratively with the client to support the drafting, reviewing, and approving the multi-phase documentation review and implementation. The following deliverables were completed:

• Master Validation Plan & Report
• New Process Failure Mode and Effects Analysis
• Process Development:
  • Design of Experiments
  • Process Specifications
  • Process Flow Diagrams to Risk Management documentation
• Validation Protocols & Reports:
  • Engineering Studies
  • Installation Qualification
  • Operational Qualification
  • Process & Performance Qualification
  • Test Method Validation

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Results

This project began in March 2020 and was completed in February 2021. At the end of the successful validation, 5 production lines were launched supporting four (4) product families in the Costa Rica facility, the client highlighted the effort made by ECl's engineering team and project manager as exceptional.