When discussing modern building techniques, the modular movement is an inescapable trend. Peter Makowenskyj and Martin Birch are two of G-CON Manufacturing's best and brightest from opposite sides of the pond that specialise in this product. Both specialists in modular design and build, Makowenskyj is the Director of Sales Engineering based in the US, whilst Birch is the Director of Architecture EMEA based in the UK.
An architect by profession, Birch understands the varying pressures on construction projects through his many roles related to the design and construction of life-science facilities, influencing his approach to design and execution. "For the last 15 years, I have worked predominantly as a concept architect and I have had the opportunity to work with many different client organisations on different types of projects," he says.
More often than not, we are competing with onsite construction
Meanwhile in Europe, Makowenskyj has previously worked for Sartorius Stedim Biotech, working hand in hand with clients, understanding their process needs and how to facilitate the design. These were typically complex projects spanning months if not years, much the same as seen on facility design. This helps him see through his client's eyes, a strength he believes is integral to his current role.
"Not only do we need to speak the same language as our client when it comes to their process in order to be successful, but we also need to clearly understand their viewpoint and clearly assimilate that viewpoint in our design," Makowenskyj adds.
Dramatic shift
Between the two men, there is over 40 years of expertise in the cleanroom sector. Through this extensive experience, Makowenskyj and Birch have formed unique takes on construction of controlled environments today. Makowenskyj says that cleanrooms have historically been viewed as a commodity item.
"That has recently been changing with technologic advancements and market drivers," he says. "It has been a great time to work in this space as we see a dramatic shift in how cleanrooms are being designed and supported in our industry."
Just as clothes used to all be custom made, then slowly moved into standard sizes, so too are cleanrooms. Advances in modular technology have meant G-CON has been able to produce products like Microcell POD, Pall Viral Vector POD platform, and iCON. These are fully formed 'building blocks' for specific uses, which will help reduce the schedule and improve overall certainty without the need for unnecessary bespoke engineering on each project.
"This really relates back to standardisation and pre-engineered solutions which facilitate speed to market," Makowenskyj enthuses. "We are not reinventing the wheel every time, instead we capitalise off basic building blocks."
These technological advancements are helping modular construction compete with more traditional methods. Birch explains: "More often than not, we are competing with onsite construction. As we see a shift into prefabricated cleanroom solutions, we anticipate more companies developing solutions in this space but as of now, we primarily compete with localised subcontractors with a range of construction experience."
Makowenskyj adds that they are also considered as equipment, allowing for accelerated depreciation over onsite construction, as well as for leasing opportunities that can support cash flow needs.
We are not reinventing the wheel every time, instead we capitalise off basic building blocks
Although modular construction can be viewed as in competition with traditional methods, Birch says it is actually a far more complex relationship. "There remains a place for traditional methods in the construction industry if it suits the project type and location," he explains.
Makowenskyj adds that there is a mature industry of modular panel cleanroom manufacturers and installers in Europe. "Typically, prospective customers compare G-CON PODs to modular panels in regard to cost and schedule," he says.
Though traditional methods still play their part, Birch does say that within cleanroom environments, 'stick-built'/ dry-wall construction are getting outdated.
"Dry-wall requires a significant amount of attention to design detailing and construction supervision to ensure that building components and complementary trades are properly integrated," he explains. "It is much better to engage a specialist cleanroom contractor that is familiar with the requirements of a cleanroom to meet with cGMP, or better still to integrate G-CON PODs."
Makowenskyj echoes this with a wider scope: "There are many projects today where the project is farmed out to multiple subcontractors who specialise in their trade but not necessarily in the biopharma sector. These projects tend to be overly complex due to the sheer number of parties involved and we have seen this negatively impact schedules and budgets."
Biopharma
Seeming very enthusiastic about the cell and gene therapy space, Birch explains that the new sector is requiring many totally novel regulations to be brought into effect, and this changing GMP landscape does not only affect the manufacturers.
"Over the past few years, we have started to see guidance documents in the cell in gene therapy space that have provided more structure on how to design and operate these types of facilities. We are seeing more of a risk-based approach which allows for more rapid implementation of newer technologies as clinical pipelines progress," Makowenskyj says.
As this new regenerative therapy sector develops, it revolutionises the services that it requires. This has pushed G-CON to supply pre-engineered manufacturing suites and building blocks that form part of a complete facility.
This new way of operating represents a pre-investment by G-CON and other stakeholders that benefits the client, and therefore, the eventual patients. "There have been touchpoints in past projects where I have gotten to walk through a clinical hospital and see directly the patients struggling through the diseases we are helping to cure. It is always fulfilling to know that in the future, these lives will be impacted," Makowenskyj says.
There has been a recent domino effect on CDMO’s falling behind schedule
Cleanrooms service many industries, so even within the sector, a specialist in the project is not guaranteed. G-CON's focus on biopharma means both Makowenskyj and Birch are very interested in the development of a new coronavirus vaccine. "When people look back on 2020, everyone will remember it for the year Covid-19 dominated the headlines and impacted everyone's life on this planet. That has been no different for G-CON and we are proud to support the build-out of critical infrastructure to support future vaccines in this space," Makowenskyj says proudly.
"While we cannot provide details on the nature of these projects right now, it is particularly important to us since many of us have lost someone due to this pandemic and we are all looking forward to getting back to normalcy in our lives," Makowenskyj adds.
Pandemic
No business has escaped the effects of the global health crisis. "We have had to hold back on shipping out facilities due to sites not being ready on time and also site groundbreaking delays which have pushed back our project schedules," Birch explains.
However, Birch also tells Cleanroom Technology that he has more recently noticed a domino effect on CDMO's falling behind schedule and the need for new infrastructure to bring manufacturing in house, and this is where the certainty and simplicity of modular technology shows its strength.
Like many servicing the cleanroom sector, G-CON has seen a major upswing in demand, not just from established industries, but from completely new business. Birch explains that obviously disease prevention is critical, and many have seen the risks associated with operating in an uncontrolled environment.
"A great deal of policies have to be put in place to ensure a reduced risk of infection but unfortunately, many of them have efficiency impacts. Moving into a controlled environment allows for both reduced risk and better operating efficiencies," Makowenskyj says.
Makowenskyj doesn't see the pandemic-driven upswing in demand for prefabricated solutions dropping off any time soon as PODs do not have the inherent risk of onsite construction.
Sustainability
From one global crisis to another, G-CON knows the win-win scenario of energy-efficient and sustainable design. "G-CON employs a series of initiatives with the MEP design to minimise energy usage. Most significantly, the POD superstructures are made from aluminium, which has a relatively high level of embodied energy," Birch says.
This also means that ultimately the POD superstructures can be recycled as well. Alternatively, they can be upcycled and repurposed as a new facility, for the same owner or a new owner. The environmental benefit is therefore realised in the POD's future life as a new facility. "The mobility aspect of our PODs has created an alternative path for cleanrooms to be reused," Makowenskyj says. A solution not possible with stick-built or modular facilities.
However, Birch recognises that sustainability is not just about the product's properties, it also lies in its production. Though many think of futuristic solar panels and crazy technology to decrease the environmental impact of a production line. But the truth is a lot simpler and less cosmopolitan. "PODs are manufactured within a controlled factory environment, by a local labour force, meaning fewer tradespersons are mobilised to a construction site for the duration of a project and the consequential environmental impact that causes," Birch explains.
No matter the crisis, it seems Makowenskyj and Birch have their eye in and are ready to respond how and where they are needed most.