Smithers expands extractables lab in Akron

AKRON—Smithers Rapra expanded its existing U.S. chemistry laboratory space by more than 40 percent, by adding a new extractables and leachables lab at the Akron Global Business Accelerator.

The expansion, which is located near Smithers' headquarters site in Akron, adds about 2,000 square feet of chemistry laboratory for Smithers Rapra. The cost of the new lab and equipment was not disclosed.

The lab adds testing capabilities to Smithers' global extractables and leachables services, with capabilities for gas chromatography mass spectrometry, ultra performance liquid chromatography/HRAM mass spectrometry, Fourier-transform infrared spectroscopy, and pH and conductivity testing. It also supports Smithers' current Akron analytical lab serving rubber and polymer product manufacturers.

"We wanted to be certain we had some of the best capabilities available on the market today in order to best serve the increasing demands of extractables and leachables science," President Nat Leonard said. "Our LC-MS system is capable of accurate mass measurements of less than one part per million."

The lab also has added a Waters UNIFI scientific information system, which allows researchers to build out compound libraries using multiple points of identification for the trace level components in samples.

"This translates into more confident identification of unknown components in samples. Ultimately, this is what will best serve our clients' needs," Leonard said.

The GC-MS system is equipped with a robotic sampler that gives flexibility in preparing samples, and a cryogenic injection system that makes analysis of highly volatile compounds more reliable and sensitive. Other equipment includes a total organic carbon analyzer.

"Between our Akron laboratories and our package testing laboratory in Lansing, Mich., we work with clients on the entire lifecycle of medical components and devices: E&L analyses, materials characterization, device performance analysis and packaging optimization," Leonard said.

Paul Cummings joined the lab's team as general manager, and led the effort for extractables and leachables, and food contact analyses, Leonard said. Cummings brings more than 35 years of experience in chemistry and leadership in the pharmaceutical industry, most recently working as a research fellow and manager of trace organic analysis for Intertek Pharmaceutical Services. He also has worked at West Pharmaceutical, Drugscan, GlaxoSmithKline and Merck.

In April, Daniel Norwood joined the organization as senior consultant. Norwood has more than 41 years of experience in chemistry and pharmaceutical research, and has worked in multiple areas of analytical chemistry, including structural analysis of pharmaceutical impurities and degradation products, along with assessment of extractables and leachables. He has conducted research for Boehringer Ingelheim, Magellan Laboratories and the Glaxo Research Institute.

In July, Alison Schweda joined as principal scientist, bringing more than 10 years of experience in chemistry and research management in the pharmaceutical industry. She worked most recently as a research scientist at the Charles River Laboratory in Ashland, Ohio.

Most recently, Wes Gray joined the team as senior scientist and project lead in September. Gray has 25 years of experience in chemistry and laboratory operations management in the pharmaceutical and pharmacological industries. He most recently worked as the research operations manager at the Pediatric Pharmacology Research Center at the University of Toledo in Toledo, Ohio.

"We're fully staffed for the time being," Leonard said. "As client demands increase, we will look to add chemists or scientists to support the business. We will be building out the technical depth and breadth of the business."

The lab is a significant investment in Smithers' long-term strategy to better serve the medical device, pharmaceutical and food industries as clients continue to seek specific expertise in new product development, Leonard said.

"These industries are growing at a rapid pace, as is demand for high-caliber services and expert guidance. We want to grow in the same direction as our clients so they can continue to count on Smithers to support their business and product development goals from start to finish," he said.

Also, Smithers' client base in North America has continued to grow, originally pulling resources from Smithers' England lab for testing.

"Opening this new lab means our (United Kingdom) lab can focus on European clients, and both labs will be able to deliver faster turnaround times for client projects," Leonard said. "Time is of the essence when it comes to extractables and leachables studies, so delivering timely results is a top priority for us."

The expansion also allows Smithers to offer consistent results worldwide, keeping in mind local concerns, he said.

"Many of our clients operate and develop new products on a global basis," Leonard said. "Adding several new experts in the field and expanded lab capacity will allow us to closely match up our resources to our clients' regional needs. It also brings a consistency in methodology, communication and data delivery to streamline the full testing process."

Smithers is keeping a close eye on increasing market demand and regulation changes to guide additional future lab expansion, Leonard said.

"We are certainly focusing our effort on this market as we see significant market demand and potential future increases in demand as regulatory requirements change or increase for other related areas such as the e-cigarette and electronic nicotine delivery system market," Leonard said. "As the business grows, we will look at expanding capacity as well as our team to support client needs."