Record-quick time to market for IVD product during pandemic

Some time ago, Nolato MediTech in Hörby completed this kind of project, in which the normal lead time of two to three years to design and build a fully automated production line had to be halved. 

And, what’s more, it was in the middle of a global pandemic!

“The customer, a global pharmaceutical company, approached us in late spring 2021 wanting us to help them build a fully automated production line for the manufacture of a new diagnostic product,” explains Pelle Ekerholm, Key Account Manager at Nolato MediTech. “The product consisted of several parts that had to be injection-molded and then assembled.

“It was a complex, assembled product, which in itself required complex production equipment,” notes Pelle. “But the fact that it was also a product that would be used to detect illnesses, conditions and infections, known as in vitro diagnostics or IVD, meant there were stringent requirements in terms of the technology and the production environment.”

Stringent standards for IVD products

Nolato MediTech is used to producing medical devices in cleanrooms with exacting cleanliness requirements. But the standard cleanroom environment wasn’t enough for this product.

“The key difference is that the production of IVD products has to be completely free of DNA,” explains Niclas Johansson, Operational Coordinator at Nolato MediTech. “So there are requirements for special monitoring of particle levels in the cleanroom, staff have to wear protective clothing that covers the entire body, with a hood and face mask, which is restrictive and means the work environment has to be adapted.”

All the material used in production also has to be free of DNA. The tinniest fragment of foreign DNA in the product would be disastrous for the diagnosis security.

“As I’ve said, we have considerable experience of cleanroom production, but we’d not worked with IVD requirements before,” says Pelle Ekerholm. “To get some advice, we contacted our sister company in Switzerland, Nolato Treff, which is a world-leading manufacturer of IVD products.

“We got some great help from Nolato Treff’s IVD specialists and were able to work together to create a solution that satisfied all the customer’s needs,” explains Niclas Johansson. “And in the middle of July 2021, the customer placed their order – not just for one but for two of the same fully automated production lines.”

We started work on the project straight after the summer, which involved Nolato MediTech, in record time, converting an existing cleanroom of 900 square meters to IVD production, moving 14 injection-molding machines to different premises, adapting the infrastructure to the new area of use and then establishing the two new, fully automated production lines.

“Usually this kind of work would be carried out with a lead contractor, but we realized that normal solutions wouldn’t be suitable in this particular situation,” says Niclas. “So we appointed an internal project manager, who put together the necessary team of subcontractors. This meant we were able to work much more efficiently with parallel subprojects to make swifter progress.”

Two to three years’ work in one year

The IVD cleanroom was validated at New Year and ready to receive the new production equipment. And everything was in place just six months later. The first line was validated at the end of May and the second a month later.

“To complete in one year something that usually takes two to three years feels like a huge achievement,” says Niclas Johansson. “Some 15 suppliers were involved, and in record time we installed 10 injection-molding machines and equipment for fully automated assembly, with environmental requirements that were completely new to us. 

“And all this during a global pandemic, with all the challenges that involved, including physical issues, production limitations and unexpected disruption.

“To successfully complete a project like this requires us to work in close coordination with the customer and our suppliers. Everyone has stepped up to the plate and been keen to do something new to get the product to market as quickly as possible.” 

“One key element of the project was the vast pool of knowledge within Nolato,” emphasizes Pelle Ekerholm. “We were quickly able to access help from our sister company, which had the know-how and experience of IVD production that we lacked. We’re never alone at Nolato; we support one another as One Nolato, so we can always offer the customer the best solution. 

“We also try to be one step ahead at all times; to be constantly ready so we can adapt to changing circumstances. In this case the key was that we had spare cleanroom capacity by building for future needs when we recently extended the plant here in Hörby.

“Because you never know in advance when a customer might need a quick response!”