Based in Switzerland, the company makes components for pharmaceutical companies using clean-room technology. See a video and more photos with this story.

A company based in Switzerland has built a $100 million, high-tech factory in Middletown to make ultra-clean items that most people probably never notice inside syringes and other pharmaceutical products.

Dan Stefanoiu, chief business officer for Datwyler Sealing Solutions, said the rubber stoppers and sealers his company makes may look insignificant, “but there’s incredible science behind it to make sure there is no interaction between the packaging and the drug.”

Datwyler’s new factory opened in September on Merrimac Avenue next to Amazon, off of U.S. Route 301.

The most common uses for the company’s products are in insulin pens and epinephrine pens for allergic reactions, said Megan Williamson, head of sales, Americas, for Datwyler Sealing Solutions.

She said she wasn’t allowed to give the names of the companies Datwyler makes products for, but said, “They are the top biotech and pharmaceutical companies in the country.”

The company plans to employ 120 workers when the factory is operating at full capacity, which is expected to be in two years. Right now, the company has 25 workers at the Middletown site and has started training workers. In addition to the jobs in Middletown, the company has increased its sales force in the United States.

“We’ve built the best plant in the world to manufacture components for drug packaging,” Stefanoiu said. “That’s a big claim, but I’ll tell you why we can make that claim. This Middletown facility is based on the ‘first line’ manufacturing concept which is unique to Datwyler.”

He said in the first line concept, “we are constantly striving for zero defects because patient safety is our top priority. There should be zero risk to the patient. We are the link between the drug companies and the patients. Our rubber does not react with the drugs. We have benchmark data to prove we have the best levels in the industry.”

Stefanoiu credited Dirk Borghs, the chief operating officer of Datwyler Sealing Solutions, with creating the innovative process, calling him “the father of the first line concept.”

Borghs said, “We’re proud to claim we have the best manufacturing concept and based on that we have built our U.S. plant in Middletown.”

The first line concept started in 2006.

“I was tasked with building the plant of the future,” said Borghs. “We found the requests from markets were getting more stringent. We made upgrades, but often they were too little, too late. We now have to anticipate requests not three to five years into the future, but 10 to 20 years.”

Borghs talked with representatives from large pharmaceutical companies to develop the new manufacturing process. He said the company’s board of directors was “shocked” with the cost, but eventually approved the plan.

“If you keep trying to improve what you have, based on old technology, you’ll never get where you need to go. The changes will be incremental. They will work for a little while. We were looking at a concept that would work for the next 10 to 20 years,” Borghs said.

In 2009, he led the design and construction of the original “first line” manufacturing plant in Belgium.

“It’s all about cleanliness,” he said. “What’s most important is in no way can the product interact with the drug.”

The plant design strives to limit particles in the air that could end up in the product.

“We studied what people wore, how people move, how machines are made. We needed to have a paperless office. Paper is one of the biggest contaminants as far as particles,” Borghs said.

Not an overnight success

The new concept didn’t translate into increased sales right away.

“In Belgium, it took off very slowly,” said Borghs.

Most companies didn’t think they needed to spend more for a superior product – not at first.

Borghs said, “It seemed like they needed to get into trouble before they said, ‘Oh, you have the solution.’”

Then the Food and Drug Administration (FDA) required higher cleanliness standards in drug packaging.

“The FDA raised the bar. The requirements became more stringent,” Borghs said.

Then more pharmaceutical and biotech companies started turning to Datwyler’s products.

Another change in the industry that helped Datwyler is the increase in production of drugs that are only needed in small quantities. Before, many of those drugs were not cost-effective to produce because companies had difficulties making a profit.

“The research is extremely expensive,” said Stefanoiu.

But as new, more innovative companies have started discovering ways to make a profit on smaller quantities, Datwyler has been able to provide the ultra-clean packaging the companies need for the drugs. After all, when a company is only making a small amount of the drug, it can’t afford for the drug to be contaminated by packaging.

“Many of these new drugs are very sensitive,” said Borghs.

He said the first line manufacturing concept makes small-batch production more cost effective.

Another major improvement Datwyler made in drug packaging is in how the parts are coated.

“Our process is a proprietary spray coating process, so the stoppers are fully coated all around. It was a breakthrough in particle reduction,” Borghs said.

The previous method was using a film coating and applying the film to the part by lining a mold with the film on the top and bottom, putting the part in the mold and pressing the film on the part; however, it was difficult to perfectly seal the part using that method. That old method works for many other uses such as automobile parts but it wasn’t effective in the healthcare business because of the high level of cleanliness required.

The spray-coated part also moves more easily in a syringe compared to a film-coated part, Borghs said.

Like making a pizza, but in clean-room suits

Frank Schoubben, the Datwyler Middletown plant manager, compared making the rubber components for syringes to making dough for pizza. First, the raw ingredients are mixed, and then the mixture goes into the sealed environment, similar to a clean room where microchips are processed.

In the sealed part of the factory, most of the work is performed by machines and robotics, with people observing the process in clean-room suits.

“Cellulose was the main contaminant in our product,” said Schoubben. “That can come from people. People shed skin and hair naturally. But it also comes from paper. We’re a paperless facility. Also we have no wooden pallets. They’re all plastic.”

To make the rubber plungers and stoppers used in syringes, once the rubber or elastomer is mixed to the proper specifications, it is cut into bricks, then pressed into a mold to make the proper shapes and then trimmed, weighed and rinsed.

Eight cameras inspect every part at high speed.

The factory has been built so that the machines operate in a cleanroom but the back of the machine can be accessed by maintenance workers in another room.

“The machines can be maintained without people coming into contact with the products,” said Schoubben.

In the clean room the air is flushed every two minutes through HEPA filters.

Products that need to be sterilized with steam are sterilized in the Middletown factory.

“We do have customers who ask for gamma radiation sterilization, but we outsource that at another company,” Schoubben said.

The Middletown factory is the company’s first facility with its own visitor center and corridors for tours. Representatives from the drug companies can see the cleanroom production without being in the clean room.

Middletown selected from about 200 locations

Deciding to build this state-of-the-art factory in Middletown was “a long process,” according to David Clark, vice president of operations, Americas, for Datwyler Sealing Solutions.

“We looked at five areas in the United States including Philadelphia, Boston, New York, San Francisco and Raleigh, North Carolina,” he said. “When we did all the analysis, we decided the Philadelphia area was the best, close to our customers and close to our other plant in Pensauken, New Jersey, so then we started looking at locations in southeastern Pennsylvania, southern New Jersey and northern Delaware.”

After visiting more than 100 locations in those three states, the search was narrowed to two, and Middletown made the final cut.

“We looked at the quality of the workforce and educational facilities,” said Clark. “We visited the University of Delaware, Rowan University in New Jersey, Drexel and the University of Pennsylvania to get the engineering and biological scientists. We met with Delaware Technical Community College to get manufacturing operators.”

Middletown Mayor Ken Branner said he believes the town’s ability and willingness to work with corporations is a big plus to enticing companies like Datwyler to locate here.

“We don’t hesitate,” said Branner. “We are business-friendly and have the ability and willingness to work with anyone interested in Middletown.”

As was done with Johnson Controls and Amazon, Datwyler was given a 10-year property tax abatement.

Branner said other benefits to locating in Middletown include the infrastructure in place – roads, water, sewer and electric – and the area selected was already zoned for manufacturing use.

The addition of 120 high-paying jobs should definitely help spur the local economy, Branner said, with the employees visiting local restaurants and retails stores. In addition, the hope is that many of them will also relocate and live in Middletown.

“In fact, I understand the plant manager at Datwyler has already found his home in Middletown,” Branner said.

Healthcare one part of global company

Datwyler was started in 1915 as a company that produced rubber and cables.

The company now has two divisions: sealing solutions, which includes the Middletown factory, and technical components.

The sealing solutions business employs about 7,000 workers and has annual revenue of about $830 million. It includes health care products like the ones made at the Middletown factory, and also items for consumer goods, civil engineering projects, industrial uses and automotive parts.

“One in two cars worldwide use a Datwyler component,” said Borghs.

Consumer goods include packaging solutions, liquid sealing, customized containers and capsules. The most well-known products in this area are the aluminum pods and silicone seals used in the Nestle Nespresso brand of hot beverage machines.

The company’s other division, technical components, includes automation electronic components and accessories for manufacturing, trades, retailers, wholesalers, universities and consumers. This division employs about 1,100 workers and has annual revenue of $460 million.