Transfer Project Ultrasonic Cleaning

Background

ECI was engaged by a medical device manufacturer to support a transfer project of an ultrasonic cleaning process for medical device components from planning through production.

Approach and Solution

ECI engaged a Senior Manufacturing Engineer to work with the client in determining the detailed scope of components to be transferred. Additionally, we determined the validation strategy based on the client's internal procedures. The creation of validation protocols, execution, closure of validation reports, were also part of the services provided to the client.

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Comprehensive Action

ECI worked with the client and identified the steps to follow for a successful transfer project, as follows:

• Understanding of ultrasonic cleaning process (process and equipment)
• Determination of the scope (part numbers to transfer)
  • Determination of worst-cases
  • Extension of part numbers to Costa Rica site (BOM and routers)
  • Extension/update of internal manufacturing procedures
  • Validation strategy determination
  • Creation of OPQ protocols (3 protocols)
  • Validation execution
  • Validation reports

The project was intended to be a "transfer-as is" project, however, during the planning phase and strategy determination it was noted that newer equipment models were adequate for the process, so, changes in the process compared to the sending site were made.

Once the proposed changes and validation strategy was agreed to by management, a multidisciplinary team consisting of personnel from production, quality, microbiology, chemistry, regulatory, and research and development was formed to create the validation protocols. Additionally, this team determined the required test samples to assure adequate samples were available and tested for the submission.

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Results

ECI successfully supported and led the ultrasonic cleaning transfer project from the planning phase to the closure of validation reports. Three different operational and performance validations were performed given the differences in the process characterization; all were successfully executed with no failures. The ultrasonic cleaning process was validated and is now running in regular production.

This project resulted in process simplification for the client in addition to lower overall costs of the manufacturing process.