With a business focus on healthcare, Samyang Biopharm manufactures medical devices and pharmaceuticals, specifically key medical products like sutures and surgical mesh.
Since 1992, Samyang has focused on producing quality products for their global customers. But as times change, they have noticed an increase in demands from their customers, as well as a change in regulatory requirements … all of which have an impact on their testing processes.
“Customers are demanding more testing data, with higher quality and more repeatable results,” said Mr. Santee, Quality Manager. “Additionally, regulatory requirements are reaching across oceans and this is requiring us to review and take more care in developing testing processes.”
Faced with these new challenges, Santee set a goal for the quality lab to reduce the spread in test data by removing or reducing negative external factors.
“We noticed that many of the tests we perform were high in volume, but also repetitive in nature,” said Santee. “We understood that we needed a solution that removed manual factors.”
Samyang’s need for improved effectiveness in the lab and understanding that their lab technicians and engineers were more valuable performing value-added tasks, Santee approached Instron about an automated solution that could complement their existing frames.
“Due to the high volume testing of our lab, and the newer regulation requirements, we turned to Instron because we had experience with their highly-responsive and knowledgeable service engineers,” said Santee. “And because they are local, they are able to assist in our testing applications, which really boost our confidence in results.”
Samyang added a robot onto their current Instron system, freeing up their technicians to do more important tasks. Additionally, they integrated the add-on compliance solution, Compliance Builder, within their Bluehill Software, helping them develop 21 CFR Part 11 compliant processes.
In addition to the increased productivity and the new-found freedom to plan for future testing requirements, Samyang reports an improvement in data quality since the handling and insertion of specimens into the machine is performed exactly the same way every time with the automation system.