40 years of innovation: Nelson Labs marks milestone in scientific testing excellence

Nelson Labs President Joseph Shrawder speaks at the 40th anniversary celebration Oct. 1. The company was started in Salt Lake by a husband and wife. (Photo courtesy Nelson Labs)

In 1985, Dr. Jerry R. Nelson and his wife, Lynda S. Nelson, started a small company in Salt Lake City called Nelson Labs and they were the only employees. Gradually they started hiring more people as the company grew and now 40 years later, Nelson Labs employs nearly 1,000 people worldwide. What started as a small company in 1985 is serving 3,000-plus customers across facilities in the U.S. Mexico, Asia and Europe.

“Jerry and his wife Lynda were doing post-doctorate work at the University of Utah,” said Nelson Labs President Joseph Shrawder. “In the course of doing that, they came across some opportunities to support companies who wanted some microbiological testing to ensure the safety of their products.”

A scientist conducts tests for bacteria. (Courtesy photos)

That was the seed of the idea for the Nelsons to start Nelson Labs, he said. “It was very small, with just the two of them. As they hired more people, they moved out of the space at the University of Utah and created another lab across town.”

They outgrew that after a few years, said Shrawder. “Then they moved to the current campus on (6280 S.) Redwood Road in Taylorsville, all the while expanding to more and more testing services and more and more capabilities to test for more things.”

It has just continued to grow and expand, he said. “Customers have basically said, ‘We do testing on X, Y, Z with (this other company). We also have to go to somebody else to do these other things and you do it all for us.’ That’s really been how Nelson Labs has expanded its capabilities from requests from existing customers who needed more length of work that Nelson was doing.”

Nelson Labs tests medical devices, pharmaceutical products, drugs and their packaging to make sure that they are safe and are compliant with regulations to be able to put them on the market, said Shrawder. “What that means generally is that they will do no harm to the human they are intended to help by being non-sterile, a product that needs to be sterile, or has a compound that could cause contamination that would be harmful if it was introduced into the human system.”

Shrawder said the lab has a microbiological test and a chemical test. “These are to make sure we’re avoiding any toxicity — anything that’s toxic that’s going to harm a patient or even a caregiver.”

Nelson Labs has a consultation with the customer about the product and how it’s being manufactured and how it’s being used, he said. “We determine what testing is needed to make sure that it’s safe. They send samples of the product, we do the testing, we give them the test results and they use those results to document their compliance with the requirements for the FDA or for the other regulators in other countries.”

Many manufactured products require a confirming test that they are sterile, said Shrawder. “We feel this is going to really change an important part of our industry. A product is manufactured, it goes through a process to sterilize the product but before it can be sold there needs to be some test of sterility.”

This year Nelson Labs introduced some innovative methods that reduce the waiting time for a test result by more than half, he said. “This means days or a week of improvement in turnaround time on testing of sterility of urgently needed medical devices and drug products. We have other areas we’re looking for in developing new testing methods. This innovation in actual scientific testing methods gets results so we can focus on staying ahead in the industry.”

The rapid sterility test has historically taken seven to 30 days, depending on the test, said Shrawder. “Now we’re five to eight days out.”

Nelson Labs broke ground on a new state-of-the-art cleanroom facility in June. A sterile medical device is taken into the cleanroom where scientists try to eliminate as much bacteria as possible. The device is put into a container with a liquid medium that gives the bacteria everything it would need to grow. Over time, they look for growth, which tells them if any bacteria has escaped the sterilization process.

“Cleanrooms are roughly 20 years old,” Shrawder said. “The design of cleanrooms has improved. It’s a step to the forefront for yet faster turnaround times and to further reduce false positives.”

The new cleanroom will have improved filter air vents and will be larger, which allows for more freedom to test more drugs and devices to get more products out to market.

“Across four decades, our teams have advanced methods from extractables and leachables to packaging integrity, supported thousands of customers on every continent where we operate and helped strengthen the standards that industry and regulators rely on,” Shrawder said. “Scaling from one Utah lab to a global network while ensuring science is uncompromised, that’s the accomplishment we’re most proud of and it’s what the next 40 years will build on.”