If you're looking for experience, it seems you could ask for no better than Integrao's Mack Powers. Trained as a mechanical engineer and with experience leading a whole host of different companies, Powers' abilities live up to his name.
To be successful in the cleanroom sector, requires you wear a lot of hats. Powers explains how that was invaluable to him starting out. "Being an engineer has been very helpful when it comes to understanding the critical design requirements of cleanrooms. For example, having the knowledge of thermodynamics, heat transfer, and fluid dynamics enables me to grasp the technical aspects of cleanrooms such as HVAC design and air movement."
The tight environmental controls cleanroom must demonstrate means an understanding of industrial automation, control systems and structural engineering has also been helpful, Powers adds. "My background in structural and mechanical engineering has also been helpful when our team used finite element analysis (FEA) models to ensure that our products would hold up to internal and external loads such as process equipment and earthquakes," he says.
Designing, building, and testing controlled environments is not for the faint of heart
Taking this expertise and relevant experience throughout the year, Powers then spent over 7 years as Director of Manufacturing. Here he was at the forefront of the modular and prefabricated cleanroom movement, which was a huge part of Powers' journey. "I started with the company in 2009 and there were very few employees," he explains. "It was very exciting to work with the team to develop and prove the POD concept. We were proving the concept not only to each other and the shareholders but also to the market. When I started with the company, GCON had a patent for the design and a partially constructed and partially functioning prototype of a 12' x 42' POD. There were only two engineering drawings of the POD which primarily consisted of a supply air schematic on page one and an exhaust air schematic on page 2. To fully develop the concept, we had to solve many problems."
These problems involved everything from the structural, electrical, mechanical and automation design, to the types of products that would be used for each component, Powers explains. "Then we had to determine the best manufacturing methods to produce the PODS as efficiently as possible, what vendors would be part of the supply chain and how we would ship and commission the PODS at our customers' sites," he continues.
In 2017, Powers took all that expertise to his role as President of Integrao, which provides a range of controlled environment services, such as; MEP engineering, commissioning, qualification, validation, regulatory affairs consulting, process engineering, toxicology safety assessments, and industrial automation.
What it takes
Talking about his favourite parts of the job, Powers has a lot to say: "The project delivery function is such a critical part of what we do," he explains. "It does not matter if you are technically competent, you must be able to deliver your scope of work within a specified time frame, within a specified budget and according to the terms of the contract with your client. This can be a challenge by itself and it requires a clear understanding of your work and clear communication with all project stakeholders."
Building faster means using capital for facilities later
Powers also talks about his ambition to always get the technical specifications just right. "Designing, building, and testing controlled environments such as cleanrooms is not for the faint of heart," he says. "The cleanrooms must work as an independent system, but they also must integrate into the overall facility envelope. Understanding both the cleanroom and the envelope and how they will work together as a complete system is a key to ensuring that the final project delivers on all user requirements and specifications. Weaving the compliance component into the project delivery and technical scope is also great!"
Powers explains the from the beginning of a project, as the teams are developing early schematic designs and concepts, records must be kept and the detailed design requirements must be captured and verified at each stage of the design, build and commissioning process. "This makes for a great challenge as well as a great sense of accomplishment when it all comes together when we complete the projects for our clients," he enthuses.
Here we are
Powers really starts to show his enthusiasm when discussing the nitty-gritty of cleanrooms design. Since he has been working in the industry for a while now, Powers has increasing demand from customers who require shorter project life cycles and increased facility flexibility to accommodate changing business model demands and changes to process equipment and technologies is driving significant change.
For example, drug developers and manufacturers need cleanrooms and facilities that are built quickly and yet will also minimally impact the ongoing operations at the site or will minimally affect the site if the project is new construction.
Some major changes included:
- The transition from stick-built cleanrooms to modular and prefabricated cleanrooms.
- Faster engineering cycles due to the ability to standardise on form factor designs with minor modifications for each customer based upon user requirements for unit operations vs. a custom design for each project.
- Lower Total Cost of Ownership (TCO) - The ability to drive down the TCO of a project by building cleanrooms concurrently with the construction of the manufacturing facility. A decrease in the total project build time of between 20-40% can be realised with some of the leading vendors.
- Total Facility Life Cycle - Cleanrooms might need to be able to adapt more to meet ongoing business objectives and the evolution of the science and technology used in the production of therapeutics and drugs.
- Higher quality materials that minimise contamination and are more durable for the cleaning protocols required.
Modular construction is a particular topic of interest for obvious reasons.
Powers states emphatically that continued integration with process equipment for the delivery of process solutions such as production environments to produce mAbs, viral vectors or gene therapies, is needed if modular is going to continue to grow as a concept.
"If the industry is designing these types of solutions and have completed the engineering work, then we are able to help our clients build projects faster," he says. "Building faster means using capital for facilities later in the drug development life cycle which translates to less risk. Also, these types of pre-engineered designs will have a greater success of approval by regulatory agencies."
Powers truly believes that modular and prefabricated cleanrooms are key to the future of controlled environment construction, especially as they continue to gain acceptance in the industries that use them.
Each company has found a way to carve out a niche in the sector
But there is more than one way to skin a cat, and Powers knows that cleanroom providers are innovative. "The variety of manufacturers and the way that each is approaching the market is interesting," he says. "There are companies that provide components such as walls, ceiling grids or FFU's and those who provide a more integrated and complete process solution based upon pre-engineered designs for the entire cleanroom. Each company has found a way to carve out a niche in the sector and I have always found that interesting."
As part of the cleanroom industry's competition, Powers talks about his current company is carving its niche. "Integrao is working with cleanroom component manufacturers, cleanroom fabricators, and bio/pharmaceutical companies by providing project and programme management, process design, HVAC engineering design, C&Q, and startup services," he says.
Specifically, Powers talks about partnerships with engineering and CQV service companies that allow it to provide these types of services in North and South America, Europe, and Asia. "Our niche within the cleanroom industry is helping manufacturers and fabricators when they want to take on more complex projects and they need supplemental project resources," he adds.
2021 and beyond
Seeing first hand the causes and effects of changes in the industry up until now, Powers has some interesting insights about trends that are happening now. "Improving the operational performance of cleanrooms while still maintaining GMP compliance is a definite trend," he says. "Several ways to do this might include using Computational Fluid Dynamics to model and simulate airflow to find the optimised balance between operational efficiency and technical performance."
Looking at the energy consumers such as lighting and FFUs and linking the settings to the occupational status or process status within the cleanroom will also be an area where gains can be made to optimise the performance.
When it comes to FFUs, Powers thinks they will continue to be used going forward to reduce energy consumption. But he also thinks that the ability to integrate the FFUs with building management systems will continue to gain importance.
The ever-present pandemic is not a factor to be underestimated as time goes on.
"When responding to pandemics and other emerging pathogens, countries will be more interested in manufacturing their own treatments as part of their public health policy in lieu of relying on other nations for the manufacturing of these products," Powers says.
The ability to integrate the FFUs with building management systems will continue to gain importance
As a result of the Pandemic, there is a higher spending rate on R&D he explains. "This will translate into more products in the clinical trials pipeline and more products manufactured," he adds. "Therefore, cleanroom manufacturers will be responding to capacity constraints within their organisations and adjusting to manage the increased demand of their products."
In addressing this growing global demand, sustainability can not be overlooked. Powers explains that his customers have varied sustainability goals, and each is concerned with how to be responsible to their patients, co-workers, stakeholders, the communities in which they operate and the planet. "We must be able to respond by understanding those goals and then working together within our own organisations to develop products and services that will help them to achieve those objectives," he says.
Powers thinks that one of the areas that might warrant focus would be in terms of mitigating the environmental impact of manufacturing. "For cleanroom manufacturers how can we mitigate the environmental impact of manufacturing and operating a cleanroom," he postulates. "From an operational standpoint, the primary challenge is to come up with solutions to meet the space classifications required while consuming the least amount of energy."
