Migration to
Prefabricated Cleanrooms

In the biopharmaceutical industry, there has been a shift away from on-site construction to prefabricated solutions. Peter Makowenskyj, Director of Sales Engineering at G-CON Manufacturing Inc., recently told Pharmaceutical Technology that speed to market and lower total cost of ownership for facilities has accelerated this movement in the biopharma sector. He also discussed the strain that the COVID-19 pandemic has placed on operations across the industry and how the situation is creating a need for additional capacity.

PHARMACEUTICAL TECHNOLOGY: What is one benefit of prefabricated construction that businesses might not know about or might not expect?


MAKOWENSKYJ: When people think of prefabricated construction, they often associate it with speed to market and risk mitigation. What sometimes gets overlooked is that prefabricated solutions can provide significant financial benefits. They are considered to be a piece of equipment, and this allows for accelerated depreciation over typical onsite or modular construction that has been more of the historical pathway in our industry. Traditional fixed installed infrastructures are depreciated for 30–40 years because they are considered to be part of the facility for tax purposes. Prefabricated, modular and mobile cleanroom units are depreciated as equipment during a period of 7–8 years (1). Also, there are advantages for people looking to preserve cash flow because this equipment can be leased.


PHARMACEUTICAL TECHNOLOGY: What are some growing practices in prefabricated construction for cleanrooms and facility design in general?


MAKOWENSKYJ: About 5–10 years ago, only a few key players specialized in prefabricated cleanrooms. More recently, we’ve seen multiple companies enter this space. This shift is being driven by demand in our industry to move to prefabricated solutions. We’re also seeing interest in adaptation to standardized and pre-engineered solutions, which typically facilitate speed to market and can drive down costs. This follows some general trends we saw years ago on the equipment side where people were looking to avoid the complexities involved in custom bioreactor and custom crossflow projects and moved toward standardized solutions. That’s definitely becoming more prominent in our space.


PHARMACEUTICAL TECHNOLOGY: What about the opposite end of the spectrum? What do you think is an outdated practice in construction?


MAKOWENSKYJ: Historically, cleanrooms have been viewed as a commodity item, but this situation

has been changing because of technological advancements in our space and the market drivers associated with that. It’s not just about minimizing upfront cost per square foot, specifically on the cleanroom side, so we are seeing a dramatic shift in how cleanrooms are being designed and supported. In addition, some outdated practices are still in use today. There are still many projects where the actual work is being farmed out to multiple subcontractors that specialize in their space. But it is difficult to maintain oversight over these skilled labor forces, especially those that are not specialized in the biopharmaceutical space. This practice negatively impacts project schedules and project budgets.


PHARMACEUTICAL TECHNOLOGY: What are the most important parts of the company-client relationship that can ensure success?


MAKOWENSKYJ: Communication often gets overlooked as a project progresses. As simple as it sounds, communication, or lack thereof, can turn a project from a success to a disaster. Each client we work with has different process needs and preferences for how they like to interact on a project level. We need to ensure that we can adapt effectively to communicate with them in their preferred methods and means. Communication is critical to ensuring success for a project.


PHARMACEUTICAL TECHNOLOGY: How has your company been impacted by the COVID-19 pandemic?


MAKOWENSKYJ: I am not aware of anyone not being impacted by the pandemic. For us, being in the biopharmaceutical sector, the pandemic has impacted us in multiple ways. We have seen projects put on hold because clients’ priorities shifted or changed. We have also seen some clients focused on building up facilities as quickly as possible so that they can get their COVID-19 treatments out to the market. And then there is the impact at the personal level. As a company, we are not immune to COVID and employees are being impacted. Luckily, we have not had any major difficulties within our company, but we have had to reexamine how we work and our workflows. We must ensure that our employees work in an environment that minimizes the risk of being impacted by this disease.


PHARMACEUTICAL TECHNOLOGY: Have you seen an increase in interest from businesses looking to prevent infection because of the pandemic? 


MAKOWENSKYJ: Yes, disease prevention is critical and many have seen the risks associated with operating in an uncontrolled environment. Many policies have to be put in place to ensure risk is reduced and infection is mitigated. Unfortunately, this will lend itself to efficiencies being impacted on a project level. Moving to a controlled environment as opposed to on-site construction allows for reducing risk and maximizing operating efficiencies when designing and building a cleanroom environment. This will allow for de-bottlenecking the constraints of on-site construction because you can have now multiple swim lanes that will have little to no overlap as you can work through them. It’s a more effective way to deal with the constraints of personal space and mitigate overlap of workers in the field.


PHARMACEUTICAL TECHNOLOGY: How do you see the market rebounding after the pandemic? MAKOWENSKYJ: We have seen an increased demand in the cleanroom space to alleviate the constraints around COVID. Sites that weren’t focused on manufacturing vaccines or treatments for COVID now are and they need additional capacity. There is also a pent-up demand for other projects that were put on hold. We anticipate that they will be released slowly and those projects will take hold. As a whole, the cleanroom space—the facility design space—has actually seen some positive impacts.


References

1. M. Jornitz, Manufacturing Chemist, April 16, 2019, www.manufacturingchemist.com/news/article_page/The_promise_of_manufacturing_in_modular_

cleanrooms/153649

About the Author

Migration to
Prefabricated Cleanrooms

Peter has over 15 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various technical roles in process solutions for the biotech industry prior to moving into management positions in technical and sales roles. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities with single use technologies. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their facilities utilizing G-CON’s pre-fabricated autonomous clean rooms.


Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University.

Migration to
Prefabricated Cleanrooms

Highlights

  • The new advancements in cleanroom technology that have led to an industry shift towards prefabricated cleanrooms

  • The financial benefits of prefabricated construction

  • How the COVID-19 pandemic is creating an immediate need for additional capacity