Value Engineering / Point of Care Diagnostic Test

Project Snapshot 

Sterling Engineering was contracted by a Japanese POC medical diagnostic device manufacturer to evaluate and optimize the cost-effectiveness of their product packaging. The company manufactures about 6 million of the tests per year. The notable expense was identified in the primary and secondary package construction and the use of desiccant and moisture barrier materials. In an early analysis of package performance, engineers discovered a weakness in the methods employed to test seal integrity. 

Sterling identified the technology most appropriate to test the package seal and a specific supplier in Ireland with a product best suited to satisfy this in-process manufacturing quality control issue. With an accurate test platform, Sterling was able to develop validation test protocols for the factory to ascertain the integrity of the current package and the ability to qualify and substitute a more cost-effective construction. 

Project Challenges 

Minimal information and legacy data was available from the initial package development and it became clear that the package was over-engineered to achieve satisfactory product integrity. 

To quantify the performance of the current package components before potential revision, Sterling had to discover a reliable and accurate package seal integrity test and instrument. 

When the test was identified, the seal integrity could be optimized. With this basis, the individual package components could be challenged to determine performance and need. And with the protocols to carry out those tests, Sterling had successfully completed the Project requirements. 

Sterling’s Solution 

As is typical of a diagnostic test, package cost reduction was desired that would not affect product integrity. The lateral flow diagnostic test materials are highly degradable by moisture ingress, which diminishes shelf life. Therefore, Sterling developed: 

• An accurate platform and process to test seal integrity
• An improved seal with existing materials to remain within current regulatory acceptance
• Test protocols with accelerated aging to allow the manufacturer to qualify then package components and constructions of a more cost-effective nature
• Test method to ultimately validate product integrity in various realistic challenge conditions to retain maximum shelf life