Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility

Equipment systems integration solutions are becoming increasingly important in medical device and pharmaceutical production facilities. There are several reasons for this including changing regulatory requirements, the need to improve the service offered to patients/users, and the need to remain competitive by making efficiency savings and increasing productivity.

These were some of the motivating factors for our client, a medical device manufacturer, in its decision to implement the Equipment Systems Integration project covered in this case study.

Objectives

The project involved introducing a Unique Device Identification (UDI) system on each line in its production facility. This new system needed to identify every product produced, a key requirement of FDA regulations as well as the new EU MDR (Medical Device Regulations) that is being implemented in May 2020.

Another requirement of the project was to introduce a Batch Integrity system on each line to ensure the integrity of all production line cells.

As a result, improving customer service levels and quality control in addition to making efficiency savings were also key priorities, among other things.

What We Did

Our client as approximately 50 medical device production and packaging lines in a single facility. The processes on those lines include automated assembly, sterilisation, and packaging.

The solution we developed included:

  • Line clearance and purge systems
  • Batch management control systems
  • Quality control systems
  • Verification systems

The solution also needed to be fully integrated with the customer’s ERP. All systems needed a GAMP 5 validation package and the solution needed to be 21CFR11 compliant.

Results

The solution we implemented met all customer requirements and now controls full data management on all lines. This includes managing the transfer of data to the equipment, identification, and verification systems, something that is a key part of the majority of Equipment Systems Integration projects.

The system we implemented also included a user interface that lets engineers and technicians create line clearance and purge interlocks as well as product changeover controls for batch management.

In addition, the system controls printers, vision verification systems, and batch parameters, plus it logs all batch details of the product.

To find out more and to discuss an Equipment System Integration project you are planning, please contact us at SL Controls today.

Mick McHale

Mick McHale is SL Controls' Projects Director. He has over 15 years' experience in project management and engineering design. His areas of expertise include managing complex systems automation projects and bringing them to successful completion in a range of industries including pharmaceutical, medical device, and food and beverage manufacturing. He also has expertise in process and front-end design.

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