Vision 2022: new year, new cleanroom

2022 is the beginning of another year of pandemic life. After two years of responding to the virus and its resulting reverberations across all industries, the cleanroom sector has truly upped its game. Innovations and new business have begun cropping up more and more rapidly and this is a trend that looks to continue into another year.

Of the new design concepts launched in 2021, multimodal facility design at the suite level is a trend that shows plenty of potential. Born of the need to balance flexibility with speed, this trend has plenty of potential, especially within the ATMP sector, which includes the popular COVID-19 treatment of monoclonal antibodies.

Multimodal facility design is an interesting concept that constitutes concurrently running various suites for different therapies at the same time, with the ability to change these suites easily to mix and match what is needed at any time.

When there is high demand and growing innovation, new business quickly follows. Cleanroom build specialist Guardtech has already announced a huge restructure after a late 2021 turnkey cleanroom construction acquisition. One of the five pillars of the companies new corporate structure is the Isoblok pre-fabricated plug-and-play cleanroom modules that will be coming out this year.

More and more projects are starting to state the use of 3D modelling, VR facility tours, AI, and digital twins as key parts of the design and build phase

Deborah Haisman, Commercial Director of cleanroom expert Validair, said: "We're looking forward to our customers enjoying the benefits of our restructured support solutions, now divided into three Service Care Plan levels."

Newly-founded CleanSpace Cleanrooms in the Netherlands has also announced its first modular crossflow cleanroom for the high-tech industry at the start of 2022. Both established and new businesses boomed in 2021, and all involved are looking to maintain this high as long as possible.

Another concept that looks set to gain prevalence in 2022, is the concept of 'Industry 4.0'. This trend has been around for a fair while, but practical implementation of the ideas seemed to really find their niche at the end of 2021. GEA even brought a VR facility experience to the Manufacturing Chemist Live - Cleanroom Technology Conference event, which was a hit with attendees. As news of new cleanroom projects come out, more and more are starting to state the use of 3D modelling, VR facility tours, AI, and digital twins as key parts of the design phase. 2022 may show if this trend is here to stay.

The letter of the law

I am sure that many of you will be holding your breath for the release of the new finalised EU GMP Annex 1 as it is believed that this will be published in early 2022. The publication will most certainly cause a lot of cleanroom service providers to have to adjust their business and protocols. From environmental monitoring systems providers to disinfectant and containment specialists, the sterile medicinal products will have a busy time of it when the document is out in the world.

The draft brought many of the individual aspects of cleanroom control into the holistic contamination control strategy, but that made the validation expectations that come with it apply too. "[It will] change the landscape in a positive way for our particle monitoring products in 2022," Haisman enthused. With the new Annex 1 fundamentally changing many things at the same time as innovation is accelerating, 2022 is bound to be a very interesting year for the controlled environment sector.

The EU is also due to release a major revision to the EU general pharmaceuticals legislation on medicines for human use later this year as part of the EU Pharmaceutical Strategy for Europe.

Following the public consultation which ended at the end of 2021, the revision will be published at the end of 2022. The updates are aimed to address shortcomings such as 'antimicrobial resistance', 'security of supply of medicines', 'quality and manufacturing' (including views on strengthening or adapting GMPs to reflect new manufacturing methods), and 'environmental challenges'. These are all factors that will greatly affect the European pharmaceutical infrastructure and beyond, cleanroom service providers would do well to keep an eye on this ruling as it will inevitably affect one of their biggest consumer industries.

We're witnessing a growth in demand for dry rooms

An interesting regulatory and standards topic is that of medicinal cannabis production and the processing of cannabis-derived products. Cleanroom players are starting to get to grips with hydroponics, and specifically the growing and processing of the plant that is now being used to treat many common ailments, such as chronic pain and anxiety. But as a relatively new product to the legal world, the production capacity is still finding its feet and for those involved in controlled environments this is a key sector to gain experience in going forward.

A rep from design and build cleanroom specialist Connect 2 Cleanrooms, reveals that the company is currently working on a large environment for a medical marijuana cultivator. "The facility we are working on is complex. For the cultivation, a cleanroom envelope with an advanced HVAC system is creating a controlled environment with the optimum growing conditions for the production of the desired cannabinoids. Cultivation areas are linked to areas for processes such as the drying and processing of the plant material."

The C2C rep goes on to explain that these areas are GMP-compliant, as medical marijuana products, like all medicinal products, must have either a Product License (Marketing Authorisation or MA), an Investigational Medicinal Product (IMP) licence for use in Clinical Trials, supplied as a Special under Regulation 167 of the Human Medicines Regulations 2012 and must be manufactured according to EU GMP guidelines.

This is a massive opportunity for growth in the controlled environment sector and gaining experience in how to apply the regulations to this product is invaluable.

Coming up short

Supply chains issues were an earmark of the 2020/21 era, from PPE, to chips, to APIs of essential medicines. After the initial problems, some of these have become long term shortages.

A headline throughout most of 2022 was the global chip shortage. Unfortunately, this does not look to resolve itself in 2022 just yet.

Fabrication facilities take a notoriously long time to build, and the increased capacity needed to make up for the shortfall will not start helping until the middle of the year at the earliest. But the domestic production push has meant that this capacity will be coming in from a lot of Europe and the US, something that those supplying to this industry will be looking heavily into.

In fact, according to a CNBC article in 2021, many of the big tech companies are looking to bring their chip manufacturing in house. Chip innovation and production limits are a bottleneck to these companies, so is a reason this opportunity seems to be drawing them so much.

High demand has drained the market of a lot of its plasmid manufacturing supply

Batteries is also an area of high tech production that is seeing some supply issues. C2C's XYZ, says: "Battery production is surging right now and tight environmental controls are needed to create a stable environment for the advanced materials involved. Connect 2 Cleanrooms is already working with a number of organisations at the forefront of battery production, both for medical devices and electronic vehicles, and for these clients the control of humidity is mission-critical."

The rep C2C explains: "We're witnessing a growth in demand for dry rooms, with an ultra-low dew point air supply of around -40°C, due to the advancements in these technologies."

Speaking of shortages, the semiconductor industry is not the only one feeling the squeeze. High demand has drained the market's plasmid manufacturing supply. An essential ingredient for both the cell and gene therapies and vaccine production, there are obvious reasons for the high demand, but without a crystal ball, the manufacturers had little to no warning. In order to 'keep the lights on' in 2022, there will be most likely be high demand for facilities that can bridge the shortage of plasmid production. Supply chain issues have hit every corner of industry. Ecolab stated transportation and logistics costs as one of the main reasons for its price increase for all industrial segment divisions in 2022. This increased cost of procurement is a factor that will be affecting the competition in many industries and it will be interesting to see how this plays out this year.

Hindsight is 2022

With COP26 lighting a fire under a lot of companies to get their sustainability in order, companies like EcoVadis are looking forward to a bright 2022. EcoVadis is a company that provides business sustainability ratings.

Companies like WHP Engineering and Howorth Air Tech are two cleanroom players that have already signed up to the initiative with aims to improve waste management and energy consumption. 2022 is also going to see the first fully qualified applications of adaptive cleanroom control in pharmaceutical manufacturing. The project, that involves EECO₂, was discussed at the Cleanroom Technology Conference in 2021 and provoked a lot of enquiry about how the experience with the regulators has gone. If this project is a success this year, it may set a precedent for other manufacturers and signal that the idea of adaptive control has the green light from those in charge.

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This is why industry events are going to be so important in 2022. Catching up with peers is essential in keeping up with all the new developments across the sector. The Cleanroom Technology Conference will be back to its normal spring date this year (barring any change in coronavirus measures), taking place in Birmingham, UK on the 25th May.

All in all, although 2020 will be the year that will go down in the history books, it is the years following great turmoil where emergency strategies turn into global trends that last for decades. This is just a snippet of the interesting advancements in the sector, at a time like this there is far too much to cover than can fit in one magazine.