Are Food-Grade Lubricants Biocompatible? An Interview with Lubrication Expert Daryl Williams
Daryl is one of our Regional Engineering Managers (REMs) at Nye Lubricants consulting customers in the Northwestern United States to help them select lubricants that best meet their specific needs. Daryl specializes in helping find solutions for demanding next-generation applications in the Medical, Automotive, and Semiconductor industries. Prior to joining Nye, Daryl worked as an engineer in the plastic components industry. Daryl holds a Bachelor of Science degree in Mechanical Engineering from San Jose State University.
Are there medical grade lubricants? Can you explain the difference between food-grade and biocompatible lubricants?
That’s a great question, many engineers have a misconception of medical grade lubricants. There is no official medical grade certification for lubricants. Nye is ISO 13485:2016 certified, which means we have quality management systems in place that consistently meets regulatory requirements for use in medical devices and applications.
Food-grade lubricants, per the Food and Drug Administration, are only approved for incidental food contact up to 18ppm. These lubricants are not required to pass biocompatibility tests. NyeMed® gels and fluids are backed by biocompatibility data and must meet ISO 10993 standards which ensure the lubricant can safely come into indirect contact with the skin and body: ISO 10993-5 for cytotoxicity, ISO 10993-10 for skin irritation and ISO 10993-11 for acute systemic toxicity.
Why is it so important that customers choose ISO 13485:2016 certified gels and fluids?
This is a quality standard that shows medical device customers that Nye operates under the ISO Quality Management System, which goes through a stringent 3rd party audit and certification process. This is the same ISO quality system our medical device customers work under and are familiar with. This standard shows that our process controls and documentation meet or exceed for all requirement for design, manufacturing and distribution of NyeMed® lubricants for the medical device marketplace.
What design challenges do engineers face when designing surgical tools? How can gels and fluids be used to address these challenges?
Each application can be very different. Surgical tools can range from catheters to robotic surgery tools, but patient safety is always paramount. Engineers are looking to reduce friction and wear on devices where they need to ensure that the added steps add value. This can include controlling precision motion, controlling haptic feel, reducing noise and vibration, sealing from blood contact and improving patient comfort. These attributes of lubricants improve device performance and mitigate risk for the manufacturer, the device user and the patient.
When compared to other industries, how does the lubricant selection process differ for medical devices?
The medical device industry needs to reduce risk and have products that can be manufactured reliably with batch to batch consistency. Their ISO standards need to be met to ensure patient safety; Nye provides data which customers can rely on for development. Nye can also formulate and modify products for even more specific needs.
Nye also offers samples for prototypes and early development needs. We understand the long development process and changes that come along with device development and work with customers to find the correct lubrication for each application.
What is your favorite part about working at Nye?
My favorite part about working at Nye is getting to work with our customers on many different applications and helping them solve their engineering challenges that can all be solved with a lubricant. Each day working at Nye is different ranging from helping customers with sealing on O-rings in medical devices to finding the perfect lubricant for e-bike gears or LIDAR sensors. Each application showcases Nye’s ability to meet specific design criteria for each individual customer.
