Peter Makowenskyj, senior director of design consulting at G-CON Manufacturing, will be speaking at INTERPHEX, where he will explore the historical and current drivers shaping facility design. EPM spoke with Peter to find out more about his insights ahead of the session.
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Your session looks at both the historical and current drivers of cleanroom facility design. If you had to summarise it, what have been the biggest forces shaping cleanrooms over the past 20 years?
Over the past 20 years, we have seen various factors at play that drive cleanroom design. The big three have always been cost, speed, and quality where often they can be at odds with one another. Cost or budget has always been a dominant factor in projects and sometimes gets defined too early and without looking at the big picture. From experience, the lowest cost option is not always the best option, especially when considering the facility lifetime. We saw a major emphasis placed on speed to market 5-10 years ago and much of that was driven by an imbalance in supply vs capacity in our production space. While this can always be critical on a project-to-project basis, the general demand for project speed has somewhat lessened over the past couple of years. Lastly, of the big three, we will touch upon quality and maybe more importantly, discuss the cost of quality. Regulators set minimum requirements that must be met but how you get there can sometimes be ambiguous and this ties into the discussion around upfront cost for operating or maintenance costs vs potential costs around batches lost or ultimately quality impacts to patients.
While these have been the major factors influencing design, you do get into subsets such as capacity alignment and scalability, future proofing, flexibility, and multimodal facilities that also come into play. Depending on the end user and their corporate objectives and financial standings, some of these other factors will often come to the forefront.
Historically, cleanroom design has often been about risk mitigation and compliance. Are we now seeing a shift toward flexibility and adaptability as primary design drivers?
For the most part, we work in a conservative industry but surprisingly risk mitigation is not a factor that many consider up front. Compliance is quite important and depending on the end user, compliance can mean many different things. Rather, we have seen resistance to change as a big factor in our industry and this is not necessarily a good thing as it impedes progress. And because of this resistance, we can often see elevated levels of risks due to lack of modernization and adoption of more suitable materials of construction or technologies. Flexibility and adaptability are important, especially for certain end users, and over the past 10 years specifically, this has been a major focus with the evolution of different types of modalities. Flexibility, future proofing and multimodal facilities will often be a major focus for CDMO’s as this gives them wide latitude with their clientele and allowing their facilities to operates near full capacity.
Cleanrooms are traditionally high-energy environments. Is sustainability now a primary design input, or is it still something layered on after compliance and operational needs are met?
Sustainability is not now a primary design input but we anticipate this to change over the next decade. When many people think of sustainability, they associate it with higher costs and this is the primary impediment to implementation. But many companies are now becoming more cognizant of the total cost of ownership for such facilities and specifically the impact of operating costs. While it is typical that implementing technology that allows for sustainability measure will have a higher CAPEX, it is now starting to be apparent that the ROI can be significant when factoring OPEX. That is why we have seen big pharma been more progressive on this front since they have the resources and capital to better evaluate.
When we talk about sustainable cleanroom design specifically, where are the biggest opportunities — HVAC systems, airflow strategies, materials, layout optimisation?
Without spoiling too much information on the talk, HVAC and airflow are definitely landing on the higher end of the spectrum. Materials are important from a circularity aspect and there will also be a great round table happening earlier in the day at Interphex looking at legacy vs advanced materials in cleanrooms. What I will say now is that from an energy perspective HVAC is the highest contributor to energy demands and as such an ideal target for better sustainable practices.
How is AI influencing facility design decisions — are we talking predictive modelling, digital twins, smarter environmental control, or something else entirely?
Every decade or so, various new facility of the future concepts get discussed and without a doubt, AI will play a critical role in the design and operations of future facilities. AI requires data to be affective and as digitalization is becoming a more common practice, AI will have the data it needs to be put into use. That is not the only factor that comes into play but AI will not work without the proper data, so it is a precursor. But as mentioned earlier, we are a more conservative industry and as such late adopters to AI. This is starting to shift and multiple companies have started presenting on case studies for implementation. We are also seeing regulators being more active in AI than they have been in the past with more revolutionary innovations. So this is a major advantage as companies accelerate adaptation. It is slowly being implemented across the board and machine learning will likely be one of the more impactful types of AI in our space.
As robotics and automation become more integrated into manufacturing, how does that change cleanroom layout, material flow, and even classification strategy?
Again, level of adoption of robotics is still extremely low in our industry but as the technology for automation and robotics continues to progress it will be critical to ensure that the facilities are designed appropriately. One of the most immediate impacts would be to the contamination control strategy of the facility since robotics does eliminate the largest source of contamination. As robotics evolve there likely will be certain design factors that will need to be considered for material transfer and handling. And as risk assessment are done, it is quite likely that classifications can shift and allow lower overall energy consumption. Pertaining to layouts it could be likely that we can condense facility foot prints as the robots may be able to operate within smaller overall footprints.
Do you think the industry is truly ready for the level of change required to integrate sustainability, AI, and robotics into facility design — or are there cultural and organisational barriers still to overcome?
Corporate culture is a huge factor in how companies embrace change and progress forward. But there is only one direction our industry is heading in now and it is to embrace these changes. Right now, the trends are slow and overall adoption is still on the low end but as with many other technology innovations, we will see an accelerated and exponential growth in adoption soon enough as percentages shift from the singe digits or teens and into the 20% levels. And ultimately, all of these efficiency gains will allow for lower overall costs, higher quality and in the end work to advantages of our patients.