Utah-based medical device testing laboratory Nelson Labs broke ground June 12 on a new multi-million-dollar cleanroom facility in Salt Lake City.
The lab provides microbiological and analytical chemistry testing for the medical device and pharmaceutical industries worldwide. It is located at 6280 S. Redwood Road.
“It’s the 40th year anniversary of the local company,” said microbiologist Thor Rollins. “We test medical devices and pharmaceuticals to make sure they are safe and sterile to use for patients. When you go to the hospital, everything you touch or that touches you needs to be sterile.”
Nelson Labs is best known for sterilization and validation that it is sterile, he said. “You don’t want to introduce bacteria into a patient. We make sure it’s sterile and that we kill the bacteria.”
A sterility test is super-simple, Rollins said. “We take a sterile medical device into a cleanroom and try to eliminate as much bacteria as possible. We put it into a container with a liquid medium that gives the bacteria everything they would need to grow.”
Rollins said over time they look for growth. “It tells us if any bacteria has escaped the sterilization process.”
The new cleanroom will have improved filter air vents, he said. “It will also be larger, which allows us more freedom to test more drugs and devices and get more products on the market.”
“We test packaging and the stability of the product,” said Zachery Anderson, senior director of the Salt Lake City lab operations. “We verify that the packaging the product is in is safe for use. Chemicals from the packaging may have come off and leached into the product.”
The cleanroom will provide a much more robust system, he said. “Our microbiologists and scientists make sure we’re meeting industry-specific needs.”
It’s a unique process, said Anderson. “If we had to shut one area down, we had to shut the whole thing down for three to four days. The cleanroom will allow us to shut down one level at a time.”
From a sterility standpoint, there is a validation process, he said. “There are processes and controls that have to take place before you can use or launch a product to ensure that it meets the regulatory bodies. We can support end-to-end.”
Nelson Labs is always focused on quality service and science, Anderson said. “We have thousands of clients with 12 labs globally in the U.S., Europe, Mexico and Asia. I’m happy to be a part of Salt Lake City, but also a global organization that safeguards global health.”