Two headlines that had profound effects on the cleanroom industry in 2022 were the war between Ukraine and Russia, and the publication of the new EU GMP Annex 1. Rising energy costs with changing standards is a very interesting combination and it has been interesting to see the start of the industry’s response.
The obvious reactions were the initial knee-jerk reaction to withdraw from Russia. Most notably for the construction sector, panel manufacturer Kingspan immediately exited the nation.
Upsets like the Ukraine war have added further strain to a recovering and vulnerable global supply network. Supply chain reliability has understandably therefore been a huge line of questioning with new clients. Microbiology experts Cherwell Laboratories’ Managing Director, Andy Whittard, says: “Whilst the humanitarian impact is unimaginable and the biggest cost, global supply chains have also been severely challenged. We have known for many years that all economies are in essence part of a giant global puzzle, however, what has become apparent is the over-reliance on a small number of manufacturers or specific regions.”
Changes within pharma move slowly, despite pressure from regulators, and I suspect it will be sometime before the industry sees the true impact of the revised guidance
- Cherwell Laboratories’ Managing Director, Andy Whittard
In solution to this problem, Whittard highlights the importance of improving supply chain robustness as a key business factor in 2023. From a business perspective, the MD also explains that good customer service and communication are vital. Keeping customers fully informed is the absolute basics of managing the continued global disruption and instability. “[This] is a key in developing a strong partnership, something which is one of our core values,” he says.
In line with this continued effect on the supply chain, the latter half of 2022 seemed to see a surge in regional HQ expansions and global acquisitions. These measures could arguably give companies greater control of their own supply, therefore less disruption.
Angstrom had already been on a spree in the early part of the year though, purchasing UK-based companies Connect 2 Cleanrooms and Specific Environments Limited in January and February respectively.
Among the other companies making big acquisitions in the cleanroom sector in 2022 were CWS, High tech conversions, ChargePoint Technology, Trescal, Sidco Filters, and ZETA Group. Although one of the most notable big acquisitions was Asgatech company Asgard’s acquisition of Puritas, a Singapore-based cleanroom firm that demonstrates clearly Asgard’s globalisation plans. The newly created entity “Puritas Asgard” is a big part of those plans.
John Comerford, Asgatech CEO, said: “Asgard has worked with Puritas on several projects within the Asian market, particularly in Singapore. We quickly came to realise the Puritas team to be extremely professional, diligent and works to high standards. We presented Asgatech Group as an investment opportunity to assist Puritas to grow further within the Asian market," Comerford added.
The business moves of the cleanroom industry really prove the show will go on!
Alliances:
- ABN and MyCellHub
- Validair and TSI
- AAF and ClearSphere
- Esco Philippines and PSM
- Humidity Solutions and HiDew
- Medhini Group, DDE, and MMF
- Elemental Machines and Kanomac
Increasing energy costs
Cleanrooms are high-energy-demand environments. Not a phrase you want to think about in 2022. With many countries experiencing skyrocketing energy costs, cleanrooms suddenly got a lot more expensive to run. When you understand the prevalence of cleanrooms as a manufacturing environment for all sorts of products, you can see why prices are rising as a consequence.
In fact, September brought an appeal from the UK's Textile Services Association (TSA) to the Prime Minister to urgently consider immediate measures to help the commercial laundry sector before cost increases are passed on to the consumer.
This financial instability makes it hard to see the wood for the trees, and prediction range in severity, but “any growth in 2023 will be bucking the trend as a long, shallow recession is the consensus from economists,” Whittard says realistically.
The MD explains that well-run and financially sound businesses will have an advantage in this situation.
Cleanroom equipment specialist Teknomek’s Campaign Executive, Shaun Speight, also explains how the company is preparing for the next year: “We have pre-purchased many of our vital stocks so, to an extent, we have taken the volatility out of the situation,” said Speight. “With regards to raw materials, we are protected well into the first quarter of 2023 providing our customers with peace of mind that delivery deadlines can be met.”
Speight says that the company also prioritised developing good strategic partnerships in 2022. “[This] enabled us to take a longer-term view and retain our overall quality, value and service model for customers,” he said. In addition, Speight says that they have provided staff with cost-of-living bonuses to help support them during this difficult period.
2022 has been a year of disruption, but also of preparation, as many issues are predicted to peak in 2023.
“The economic pressures on both our customers and competitors are increasing, so there is a possibility of people turning to cheaper manufacturing alternatives that aren’t fit for purpose, or even looking to the second-hand market for their equipment. Of course, opting for furniture which is manufactured from less robust materials or which has already suffered damage by prolonged use of cleaning chemicals is a dangerous, and ultimately expensive, choice when it comes to contamination control and risk management,” Speight says.
This focus on long-term value, rather than short-term savings is why Teknomek have taken the decision to continue to focus on high-quality products. Learning from the pandemic, the company launched its new Hygienox range specifically made for cleanrooms.
“Moving forward into 2023, we know that many of our customers are planning ahead,” Speight adds. "COVID has taught us that forward-thinking and taking preventative measures is critical. Whilst not wishing to prey on fear, we all need to be prepared to deal with any new health scares. 2022 has taught us to make the right decision, not the easiest decision.” Speight also tells Cleanroom Technology that the company is currently developing a partnership with Sealwise, adding to its cleanroom/laboratory offering with its PVC laboratory furniture.
All of these company movements demonstrate the range of measures and strategies that can be taken to offset and prepare in 2022 for hurdles coming in 2023.
Acquisitions and mergers:
- Sidco Filters acquires Roome Technologies
- Trescal acquires Cleanroom Management International
- Angstrom Technology acquires C2C
- Olestra Cleanroom and PPG Cleanroom merge
- PE buys AirCare Automation
- CWS acquires Gorex (DACH)
- High tech conversions acquires JNJ Industries
- Chargepoint Technology chooses PuroVaso
- Crowthorne acquires Absolute Caron Filters
- Asgard acquires Puritas
- ZETA Group acquires stake in Biotree
- Imtech acquires Spie UK
Keeping the globe in mind
Long-term value vs short-term gains is also one of the main reasons being used to incentivise companies to be more eco-friendly. HVAC giant AAON released its 2021 ESG report in October, detailing the industry-leading use of a new innovative product through engineering, manufacturing, and testing its Zero Degree Cold Climate Air Source Heat Pump.
Cleanroom industry players should look not just at their own carbon footprint, but at the carbon footprint of the products they are buying as well, in order to encourage and support climate-saving initiatives.
In July, contamination control service provider for the life science industry, STAXS, announced the start of the ambitious construction of a dedicated carbon-neutral facility in the Netherlands. Energy usage for the facility will remove fossil fuels as a source entirely.
Business milestones:
- Envair moves HQ (UK)
- New consumables range from Integrity cleanroom
- New $14.2m hub for AES
- Camfil expands in Malaysia
- Viet Air Filter expands in Vietnam
- G-CON launches PODs in Europe
- ZETA opens in Singapore
- Prudential makes $35m investment (US)
- Extract Technology expands in UK
- QleanAir enters Japanese market
- Wiskind expands panel production
- WHO recognises MRC Cleanroom Systems
- SentrySciences moves HQ (US)
- KeyPlants launches in the US
- DPS Group expands in the US
- Saint-Gobain invests in C-Cube
Annex 1
The deadline has been set. By August this year, all sterile manufacturers of medicinal products will have to comply with the new standards set by EU GMP Annex 1. A daunting task for many, but the contamination control sector is hot on the heels of the new document with services to help companies comply.
“Changes to Annex 1 EU GMP have made hygiene requirements stricter in the production of medicinal products, Speight says. “We are continually evolving and developing new products to help our customers meet these new requirements.”
But much of this implies spending some money. Not something that is welcome during a cost-of-living crisis.
“Changes within pharma move slowly, despite pressure from regulators, and I suspect it will be sometime before the industry sees the true impact of the revised guidance,” says Cherwell’s Whittard.
But the writing is on the wall, change is coming.
New tech:
- POSS Airborne disinfection system from Airsurdis
- CGT modular cleanrooms from Germfree
- Mobile powerstation for cleanrooms from DTG
- POD concept from KeyPlants
- Lint-free wipes from AAwipes
- Hygienox cleanroom equipment from Teknomek
- Multi-compendial WFI from ILC Dover
- Endotoxin detection machine from Lonza
- 6-hour microbial test from Microgenetics
- HEPA exhaust housing from Camfil
- Modular range expansion from Guardtech
- Four glove isolator from Team Sinergie
New tech, launches, and milestones
Despite the troubles in 2022, there are those that have launched new endeavours. In a big year for modular cleanroom solutions, G-CON Manufacturing launched its modular PODs in Europe in March, whilst KeyPlants launched in the US in September. Sweden-based KeyPlants first released their pharmaceutical concept in June, so was a quick turnaround time to the US launch. Germfree also launched a specific modular solution for cell and gene therapy applications in late 2021, but followed this in 2022 with a sterile product prep line featuring BSCs and pass-through boxes. Guardtech also launched an expansion of its modular line, with three new standard models.
New microbiological tests were released by Lonza and Microgenetics, with the latter having a staggering six-hour results time.
A theme that has popped out of much of the 2022 news cycle is digitisation. With the pressures of money-saving and regulation changes, data is often a way to detect problems and inefficiencies, and often the capital cost can pay for itself with time. The Valgenesis and Zenovative partnership in May will provide a way to digitise validation in pharmaceuticals. The partnership combines Zenovative's Industry 4.0 expertise with ValGenesis' validation lifecycle management software.
Companies like pharma engineering powerhouse NNE have also stated continued focus on digitalisation within the company.
The digitalisation trend only gained traction in 2022, so 2023 will show if this trend will continue.
Let's see how it all plays out...
For a year that has been hard on many, with a pandemic hangover, a war, and a cost of living crisis, 2022 has still seen a thriving cleanroom sector. It will be interesting to see how 2023 measures up, and how all of last year’s preparations play out.
