US market report | A year full of problems, 365 days of solutions

The US is in a period of great transition when it comes to manufacturing. For years the trend had been to move production abroad, but as the effects of the COVID-19 pandemic are sweeping the globe, this seems to be reversing. Those in the US cleanroom sector are reporting huge changes in their daily operations, and speaking to them it is clear that this is an era of change.

Claire Barber, Marketing Manager at architecture, material decontamination and high containment specialist PBSC, is seeing this change first hand.

"With the repatriation of companies coming back to the US, the biotech/pharma market will provide the best opportunity for growth in 2021 and well beyond," Barber says.

Barber explains that in the northeast alone, there has already been a commitment for new laboratory facilities totalling close to $3.1 billion with projects starting mid-2021 and continuing through 2023.

"The same can be said for mid-Atlantic and West coast with startups and expansions happening throughout these areas," Barber adds.

With the repatriation of companies to the US, the pharma market will provide the best opportunity for growth

Bret Asper, the Chief Operating Officer from Clean Rooms International, says that this is because domestic suppliers have been much more reliable than from overseas.

VP of US Business Operations at Mecart, Charles Lipeles, sees a trend in cleanroom construction projects that reflect this repatriation. "We continue to see the market as very wide open and poised for continual growth," Lipeles says. "The US demand for quality cleanrooms continues to grow and we continue to see the shift towards modular construction across most sectors, especially those requiring higher specification rooms like pharma/biotech, cell and gene therapy, and 503b compounding to name a few."

Barber uses Pfizer and Moderna as prime examples of this trend of larger biotechs and pharmas moving production back to the US, or at least starting construction back up in production lines. "Both Pfizer and Moderna are building new facilities in the Midwest that will be able to double and triple their vaccine production within the next 18 months," she explains.

Though the increased interest in cleanroom production must also in part be attributed to the vaccine production effort for COVID-19, it can't be ignored that there has also been a push for increased indoor air quality across the board. Asper flags this as one of the main trends he noticed over the course of 2020 and into this year. "Standalone HEPA filtration units have been a focus of the market and modifying our existing product to meet these needs has been an exciting project" Asper enthused.

The US clearly led the global effort in aggressively pursuing vaccines

This is just one example of this trend of higher cleanliness demands from formerly less stringent industries. The trouble now seems to be the huge demand on cleanroom service providers, in uncertain times. Both the materials and labour force will need to see major expansion to keep up. "We see 2 major challenges for 2021," explains Lipeles. "First plant capacity to manufacture high-quality panels for our customers who continue to seek shorter lead times and quality labour across all portions of our business; engineering, manufacturing, and installation."

This expedited demand has accentuated an already prevalent and growing trend for modular technology.

"Companies like G-CON [Manufacturing] have been hitting their stride when it comes to this technology," Barber says. "With module/mobile cleanrooms, it gives potential customers more abilities than having to retrofit an existing space. The modular option has everything one needs and in completely mobile form."

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Projects

In the last year, there has been a whole host of interesting cleanroom projects taking place.

Asper says that demand has been strong across all sectors. Pharmaceutical and medical projects can be seen for obvious reasons, but the high-tech manufacturing and food sectors have also seen surges in demand for controlled environments. Food would seem to be due to an understandable public concern with virus transmission, but high-tech manufacturing is a bit more complex.

There are now semiconductor shortages due to factory shutdowns in Asia that need to be addressed as many companies that use these products have to halt productions. Ford was one such company that had to slow production of their F150 pick-up trucks due to a lack of supplies. Addressing this will mean increasing US production, and this will have inevitable effects on the cleanroom industry.

In a discussion about new undertakings, Lipeles talks about a large project he was part of with Mecart for a Fortune 500 company. The project supported the client's production of various sterile projects for COVID-19 test kits. "This was a fast-tracked project that we started during the COVID-19 peaks of the early summer [2020] and completed just recently in mid-February. It was very rewarding for us to deliver this cleanroom on time and under budget and then see actual products going to the 'front lines' to support the fight against COVID-19."

US market report | A year full of problems, 365 days of solutions

Lipeles adds that Mecart is continuing to work on new techniques to minimise the energy use of these projects for sustainability reasons, such as maximising recovery in the HVAC portion of its turnkey solution. This is something a lot of projects being commissioned now are really interested in for the environmental benefits and financial savings.

PBSC has also worked on a number of high-profile projects in the US throughout 2020.

Barber explains these projects often involved the company's vaporised hydrogen peroxide decontamination chambers and hatches with validated Log6 cycle times. These high containment solutions were in particular demand as they are suitable for applications from BSL2 to BSL4, which are useful for working on pandemic-related products.

"Local expertise has given PBSC the strength to complete high standards," Barber says. "For example, Lonza/Houston had asked us to build several large decontamination chambers, providing low heat decontamination solutions to add additional support to their ramped-up vaccine facility in Houston, Texas. As part of Operation Warp Speed, they were contracted by the government to assist and expand their current capabilities."

Cleanroom manufacturers building the products can’t work from home

PBSC UK and US are scheduled to deliver these chambers in late March 2021 after beginning talks back in April of 2020 with Lonza. Barber says that the company also opened a new office in Boston at the beginning of 2020 to support the company's growth.

Speaking on the part of the consumer, Barber says the biggest challenge has been finding companies with availability and that keep within the projected timelines. "This is largely in part due to difficulty securing supplies especially if those supplies are coming from overseas," she says. "At PBSC, we are running into that when it comes to getting finished goods shipped to the US."

Asper concurred with these shortage issues, stating supply chain reliability as the biggest challenge in 2021. And although Mecart saw no disruption being its modular cleanrooms across the US/Canada border, Lipeles says that he saw dramatically mixed views on this in 2020.

Consumables

The US and companies based in the country have played a significant role in the global fight against the pandemic. "The US clearly led the global effort in aggressively pursuing vaccines and then quickly, but safely, moving them into production," says Lipeles. "Manufacturers in the sterile cleanroom space helped support this effort!"

While the US lead the pack in vaccine development, an area of business that has been dominated by China for so long is PPE. This import issue caused significant problems for many countries, including the US, at the beginning of the pandemic. This shortage was also coupled with a rise in demand for vaccine products and the concurrent surge in facility construction that has trickled down to the already strained supply of consumables.

"We saw a large pick-up in customers needing rooms for consumables but more on the virus production side of things (as opposed to PPE) for customers that needed higher quality, sterile, GMP rooms for their products that were used to test or fight the COVID-19 virus," explains Lipeles.

Speaking about how the demand for consumables has been met, Asper says: "It's been good from a response time standpoint but has also brought in companies not familiar with the segment which has and will cause problems."

Barber agrees that it is an augmentation of the current supply chain but does not think that the changes will have any bad influence on the US market long term.

Increased demand on consumables supply is not only down to the pharmaceutical industry but also largely due to the medical sector. "We have seen strong growth in pharma, biotech and medical as the pandemic has focused attention (and dollars) here," said Lipeles. "I don't see that letting up anytime soon."

Homeworking on the front line

Many companies have been instituting home working, to varying levels. With cleanrooms, there are of course some processes that require a physical presence but it is a balance.

"We have moved the bulk of our office staff to a work from home regime but of course as a manufacturer and installer of cleanrooms we still have a majority of our team working in the factory or onsite with our customers," Lipeles says. "We do our best to stay abreast of the best practices to maintain the safest possible work environments while still maintain our efficiencies."

Barber tells of a similar situation. "We have not had any issues working remotely," she says. "Of course, our production side has gone on and have had to accommodate the occasional shut down for a brief period of time if someone tests positive but for the most part, we have all become accustomed to some type of work at home hybrid model."

It seems US cleanroom companies are hitting their stride when it comes to addressing pandemic problems. They are finding innovative solutions to the problems presented in order to support the front line work that the whole country, and the whole world, is relying on.