The demand for cleanrooms, controlled environments and consumables for these hi-tech facilities was fuelled in 2019 by unprecedented growth in the life sciences and semiconductor industries.
In the pharmaceutical market, for example, developments in new drug candidates, biotherapeutics, including booming cell and gene therapies, were behind business decisions that saw several drug-makers either expand existing manufacturing plants or acquire new sites.
WuXi, the Chinese CDMO, was among the companies that made high-value investments for the construction of new GMP manufacturing sites at home and abroad, tapping into the increased demand of viral vectors, vaccines and APIs. The company is investing US$240 million to build a new vaccine manufacturing facility in Ireland.
On the hi-tech manufacturing front, advances in wafer technology, coupled with the increasing demand for faster processing capabilities and minuscule electronics, has pushed semiconductor and chip manufacturers to upgrade production facilities.
In Korea, for example, SK Hynix is building four new semiconductor fabrication plants at a technology cluster in Seoul. Construction work on the 53,000 sqm site in Icheon is expected completion in October 2020. Read our review of significant GMP cleanrooms and hi-tech projects.
Mergers and acquisitions
The upward trend across the industries where contamination control is a must had lent itself to strategic business takeovers.
CWS Group, for example, the German solutions provider in hygiene, workwear and fire safety, agreed to acquire the laundry division of Staxs, the Dutch contamination control specialist, in a move to strengthen its position in the Benelux market. Find out all the details in our review of the key management shake-ups of 2019.
New products on the market
Cleanroom builders, consumables specialists, and equipment manufacturers launched innovative solutions in 2019. G-CON Manufacturing, for example, joined forces with L7 Informatics and developed a new SmartPOD, a fully integrated modular cleanroom and manufacturing software solution to improve biologics manufacturing. Read our review of the top new products on the market.
Regulatory affairs are the bitter-sweet taste of 2019. While the expected publication of the GMP Annex 1 is still uncertain, new documents in the ISO 14644 standard, the new part 16 on energy efficiency, were welcome additions to the industry.
EMEA General Manager at Lighthouse Worldwide Solutions
To get a better grasp of what lies ahead for the global cleanroom sector, leading personalities in the business have shared their analysis, 2019 highlights, and expectations for 2020.
For Hasim Solmaz, EMEA General Manager at Lighthouse Worldwide Solutions, the August release of the ISO 14644-3:2019 was one of last year's milestone moments.
The document provides guidance on the test methods to meet air cleanliness classification and is the result of a long period of discussion at the ISO/TC209 Working Group 3, where Solmaz is a member.
Solmaz also pointed to the growth in biotechnology, one that is likely to continue in 2020.
“Genome editing and personalised medicine will grow in 2020 due to extensive projects at the final stages. I wouldn't be surprised if cancer-curing therapies in different clinical trials were announced in 2020. This approach will also change the dynamics of pharmaceutical production giants, as we see a lot of investments in biotech start-ups by the big companies,” he said.
Cherwell Laboratories Managing Director
Cherwell Laboratories is one of the companies that seized business opportunities in 2019 and is now bullish on the prospects of its expanded portfolio. The company, together with Development Bank of Wales, took a minority holding in Pinpoint Scientific last September.
“Pinpoint is developing an exciting range of viable air monitors for the pharmaceutical industry. The ImpactAir range of air monitors will directly address the need for continuous monitoring within Grade A environments as per the revised Annex 1,” said Managing Director Andy Whittard.
For the Cherwell boss, growing demands around environmental monitoring within pharma will continue in 2020. “We see the ImpactAir product, alongside our range of prepared media, as being a key offering and we certainly look forward to discussing the new challenges with customers and prospects,” he noted.
The opening of a London office is Connect 2 Cleanrooms' highlight of 2019, MD Mike Wright said. “With an increasing amount of customers looking to standardise their clean operations across multiple manufacturing sites, we are looking forward to increasing global market penetration in 2020,” he warned.
The cleanroom specialist has deepened its presence in Europe, and now provides modular cleanroom, validation, consumables and equipment supply across the region. Wright explained: “In 2019, we increased our reach into pharma and healthcare markets with some key contracts awarded for delivery in 2020. With the planned introduction of GMP Annex 1 and an increased focus on Contamination Control Strategy implementation, our business model has never felt more appropriate. We will continue to support our clients in their complex and challenging environments with our integrated cleanroom services.”
VP of US Operations at Mecart
Trends in construction
Cleanroom construction specialists Exyte, Brecon and Mecart reported a positive 2019 and expectations for the year ahead are on par with the previous period. “We were very excited to see more and more small and midsize customers selecting modular cleanrooms for their needs,” said Charles Lipeles, VP of US Operations at Mecart. /p>
Lipeles noted the company had a solid year and was awarded multiple projects across all pharmaceuticals and biotechnology, compounding, and semiconductors. “We expect continued success in 2020 as the need for quality cleanrooms grows in the highly regulated world that we all live in,” he said.
Exyte took home two ISPE’s Facility of the Year Awards for its project with Kantonsapotheke Zurich (KAZ) that saw the construction of a new compounding pharmacy for Canton Zurich hospitals, and that's company's highlight of 2019. “This compounding pharmacy stands for a true shift forward. It leads to the very concept of hospital pharmacies into the future and establishes benchmarks of operational excellence never seen before in patient-focused facilities,” said François is President Global Business Unit Life Sciences & Chemicals. The site has achieved a performance record of 60 to 90 minutes turnaround from diagnostic test and prescription to patient injection for cytotoxic compounds used oncology.
Kleanlabs Co-Ffounder and CEO
The Exyte boss revealed that 2020 will see the company promote the ExyCell, a new patent-pending technology, and products tapping into the cell and gene therapy and biomanufacturing.
For Gabor Hangosi, co-founder and CEO of pass-thru specialist Kleanlabs, 2019 was a year of significant expansion. He explained: “Cleanroom users have begun to focus on the accuracy and precision of material flow. Besides the installed cleanroom hinged doors, there is a significant increase in the number of installed transfer hatches.”
The latest trend in the industry, Hangosi said, is the implementation of inbound and outbound material flow separately, with active ventilated transfer boxes. “This is an explicit trend that is clearly followed by our sales” Hangosi explained, adding that KleanLabs is set to introduce a range of new products to tap into this trend.
Geerd Jansen, General Manager and Head of the PP4C(E) alliance, said both organisations secured various projects in 2019 commissioned by hi-tech companies and pharmaceuticals. Jensen named renovation work at Zeiss SMT in Oberkochen, the construction of more than 2.500 sqm Cleanroom at Zollner in Bayern and a White Room in France for Dutch partner BOA among last year’s highlights.
“The Brecon Group again has a well-filled order book for the coming year," Jansen said. He pointed to the increasing use of air recirculation and FFU technology, based on the higher impact of sustainability demands, and the increasing interest in AMC filter technology within specifically the semiconductor-related market, as trends likely to continue in 2020.
Expectations are high. Now it is a question of whether the political and economic climate will remain stable for making 2020 another year of growth.
N.B. This article is featured in the January 2020 issue of Cleanroom Technology. Subscribe today and get your print copy!
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