Case Study

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. Notable expense was identified in the primary and secondary package construction and the use of desiccant and moisture barrier materials. In 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 Location
Japan & Ireland
4 Months
Project Team
2 Engineers
Medical Device

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

An accurate platform and process to test seal integrity

Test protocols with accelerated aging to allow the manufacturer to qualify then package components and constructions of a more cost-effective nature
An improved seal with existing materials to remain within current regulatory acceptance
Test method to ultimately validate product integrity in various realistic challenge conditions to retain maximum shelf life
By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information.