Medical Device Manufacturing Facility – Device Assembly and Packaging Line Validation

The Challenge

A large mid-western pharmaceutical company planned to upgrade an existing device assembly and packaging line to increase production capacity to keep up with market demand. The scope of the project included increasing overall line speed by at least 20% and increasing line production by replacing manual operations with automated equipment and improving line efficiency. Because the line operated 24-7 to meet product demand, the project had to be implemented in phases with minimal line downtime.

The Solution

PV was selected for this project because of their strong performance on previous projects where they had demonstrated the ability to develop and implement a validation program that balanced the company’s policies, procedures, and practices with industry standards, best practices and innovative ideas. Additionally, resources were able to work as part of the project team and provide more than just validation document support.

  • The PV Validation Coordinator was responsible for creating and implementing a validation strategy that improved and expanded the existing validation documentation while also supporting a multi-phase implementation.
  • The PV team worked closely with client engineers and vendors to develop customized design and testing documentation for each new piece of equipment and for changes to the existing equipment.
  • PV engineers worked side by side with the client and vendors to resolve equipment issues and to ensure the equipment worked correctly and reliably. During implementations, PV was intimately involved in equipment adjustments, programming modifications, test execution, and issue investigation and resolution.
  • The PV team utilized our internal quality system to ensure that all documents were peer reviewed for technical content, procedural compliance, grammatical correctness, and organizational logic prior to issue for client review.
  • The PV team developed a strong working relationship with the quality department to ensure the documentation met their expectations and also challenged them with new styles and approaches. The good communication and positive relationships with quality also helped to ensure that documentation was able to be reviewed and approved in a timely manner with minimal edits and revisions.
  • The PV Validation Coordinator participated in weekly project planning meetings to ensure the project was implemented smoothly.

The Results

Implementation was satisfactorily completed within the limited time allowed and within budget.  At the completion of the project, the client was extremely pleased with how smoothly the project had gone and how few issues arose during implementation. This was achieved through detailed implementation planning, excellent teamwork and communication among the project team, and the flexibility and dedication of team members willing to work long hours, nights, weekends, and holidays in order to meet the needs of the customer.

The Benefits

The completed project accomplished the following for the device assembly and packaging line:

  • Phase I added two faster operating speeds which enabled the line to operate up to 40% faster.
  • Phase II was a Kaizen event where the operation team identified multiple incremental improvements that resulted in significant efficiency improvements.
  • Phase III installed the following new equipment:
    • 4 component feeding systems manufactured by Service Engineering
    • Customized automated machine that places caps onto the device
    • Cognex vision system for tamper evident label inspection
    • IMA Casepacker/Palletizer at the end of the line
  • Phase IV added a data matrix code (DMC) reader for part verification to facilitate shipping products for sales outside of the United States.

For additional information, contact:

Brad Henry
Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana 46241
(317) 248-8848
(317) 727-8495 Mobile
e-mail