The Knowledge Bench™ Guides a Global Medical Device Manufacturer to Success

The Knowledge Bench™ at Network Partners Group assists a Packaging Engineering Apprentice in improving quality control processes.

Results at a Glance

• Identified solutions to overcome roadblocks encountered by our client-based Packaging Engineers
• Provided subject matter expertise in EUMDR compliance to our client-based Packaging Engineers that resulted in highly effective solutions to our clients’ packaging programs
• Generated an action plan to remove barriers
• Resolved problems with equipment and processes
• Improved packaging quality control
• Reduced risk to the manufacturing process
• Effectively deployed The Knowledge Bench™ to assist our clients

Background

The Knowledge Bench™ is a team of industry professionals in the areas of Regulatory Affairs, Packaging Engineering, Labeling, Quality, and Project Management at Network Partners Group (NPG). This group is composed of subject matter experts, readily available to support our professionals, as well as any other partners at the client company with any challenges they encounter.

This case study features a global medical device manufacturer that produces terminally sterilized class III products. The packaging engineering activities demonstrate an example of deploying The Knowledge Bench™ to help develop and execute a package test method development and validation at their external manufacturer site.

Challenge

The challenge involved deploying new packaging test equipment for implementation into the client’s external manufacturers’ operations. The packaging test equipment was integral to the execution of an in-process quality control test for sterile barrier integrity. The necessary Good Manufacturing Practice (GMP) activities were to perform a test method validation of the specified packaging integrity test. The implementation of a validated package integrity test method reduces the risk of manufacturing packages with compromised seal integrity which reduces risk to patient safety.

Results

The NPG Packaging Engineering Apprentice was an integral member of the client’s cross-functional team, tasked with successfully implementing an in-process quality control test method for sterile barrier packaging integrity. The project included the validation of the sterile barrier packaging integrity test method and obstacles were encountered and overcome during the test method development with the new package test system. The clients’ cross-functional team partnered with NPG’s Knowledge Bench™ through the Packaging Engineering Apprentice and the equipment manufacturer to overcome test equipment test method development roadblocks, which included a system software program hiccup.

The Knowledge Bench™ leveraged its relationship with the package test equipment supplier and provided the necessary resources to solve the software issue. This allowed the Network Partners Group Packaging Engineering Apprentice to continue with the test method validation activities. The effective utilization of the Knowledge Bench™ provided the additional expertise and leverage to quickly overcome a technical challenge and move the project forward to implement an in-process quality control test method.