Q: My company will be constructing a new clean manufacturing facility. Where do I start?
A: “Let’s start at the very beginning, a very good place to start …” Maria, from The Sound of Music
While it’s probably safe for me to assume that most of you didn’t sing along as Julie Andrews taught her young charges to sing in The Sound of Music, the advice of the famous movie governess rings true in the reality of developing a new controlled environment. So following are seven basic rules to remember when planning your next clean facility.
Rule #1: Process rules
Simply stated, every single decision you make is grounded in the process requirements of your facility, as well as any future anticipated requirements that you can feasibly discern. Process in the controlled environment—driven by product, procedure, and regulatory requirements—rules.
Your job is to understand the product roadmaps, the research plans, the regulatory drivers that all impact process decisions. Get to know the key members of the development, R&D, and operations teams so you can not only understand their needs but form an alliance to ensure you develop and deliver the facility goods, and effectively troubleshoot any operational issues that arise in the future.
Process requirements will drive every decision of the design and engineering project, from positive or negative pressure and ISO requirements (consider your facility’s current and future cleanliness specifications and pick a number from 1 to 9), to decisions impacting size, layout, structural design, HVAC, filtration, process piping, waste handling, circulation, and hazardous production materials to name a few.
Bottom line: if you skimp on the front end knowledge base, you’ll pay at the back end.
Rule #2: Be a master of the regulations
Many sectors that utilize controlled environments are highly regulated, on top of standard land use, building codes, and local regulations that define and shape any building project. Failing to keep abreast of changing regulations is a cardinal sin. Bring in the outside guns if your schedule is too overloaded to keep pace with changing regulations.
Rule #3: Get the right planning consultants on board
The right engineering and design firm for the job may not be the guy or gal at the golf course. Don’t make these decisions on the 18th hole after they’ve just let you win. That boost to your ego will be short lived if the firm’s design capabilities score lower than your golfing abilities. Leave them on the 18th hole and move on.
So how do you evaluate and select the right engineering design firm? Here are a few critical factors to evaluate:
• Controlled environments are unforgiving design challenges in a multitude of ways, mainly because you are controlling within strict parameters on a number of environmental fronts, including particle count, humidity, temperature, and air flow. There are a multitude of ways to engineer for desired outcomes. As Albert Einstein said, “The only source of knowledge is experience.” Don’t let your project be the guinea pig.
• Lowest price can be costly in the long run. When evaluating proposals and design/engineering partners, try not to look at proposed fees until after you’ve thoroughly evaluated the candidate firms. In today’s world of tight budgets, it’s easy to be seduced by low fees. But the old adage that you get what you pay for may be true.
• Compatibility is important. Choosing an engineering partner isn’t an eHarmony exercise, but ensuring your two companies and key personnel have compatible approaches to the project is one significantly important, and often overlooked, criterion. You could be together on a project for several years; make sure you and your team can work with them and respect their knowledge.
Rule #4: Carefully select the best project delivery methodology
When it comes to a construction project, there are a variety of ways to skin the cat. Don’t find yourself stuck in the decades-old time warp of design/bid/build. It could be costing you lots of money and lots of time.
Investigate design-build, construction management, Integrated Project Delivery, and the other hybrid options in the design and construction world today. While too extensive to review here, there are shifts happening in delivery methodologies that you need to understand before heading down any delivery path.
Rule #5: Pay attention to cleanroom components
Choose the components of your cleanroom carefully, based on both immediate needs and future requirements, remembering my earlier admonition to consider life cycle costs. While cleanliness is Rule #1, ease of maintenance, flexibility for process, R&D, and product shifts are all factors to consider. An examination of wall, flooring, ceiling, and HVAC options warrants a more in depth discussion than space allows, but this is another area where the investment in an outside consultant’s time will deliver a short payback in issues avoided.
Build with room to spare, but don’t overbuild. One common mistake is the failure to program adequate square footage into the plan at the outset, not only to accommodate future growth but to provide for support systems. That means adding additional square footage around all sides of your “box” to handle expansion of air, water and chemical transport, and conditioning systems. Some suggest three feet all around your layout as an upside allowance; others prefer to determine best practice based upon each situation.
Consider that an appropriate mix of standard cleanroom, mini- and micro-environments tailored to your process or research requirements is smart money. Always ask: how much cleanroom; how much clean zone?
Rule #6: Don’t forget energy
Controlled environments can be unforgiving energy gluttons—but that need not be the case. Significant advances in engineering for sustainability and reduction in energy usage have been made. But be diligent in ensuring that sustainability measures meet the “Green for a Reason” threshold we employ at SMRT: every decision to “go green” must result in technically sound and highly functional buildings that make economic sense, and are operationally sound for the client moving forward. While that may appear to be an ode to many masters (and includes considerations of things such as the capabilities of the facility’s maintenance staff matched against HVAC and other systems), this approach has resulted in successes including the country’s first greenfield clean manufacturing facility awarded LEED Gold upon construction completion.
Rule #7: Look at lifecycle costs, not just initial costs
You will often be faced with a pretty clear choice: err on the side of first money into a project, or the side of reduced life cycle costs. Adapt the saying that one “needs to spend money to make money.” However, sometimes it makes sense to “spend money to save money.” Make sure your process thoroughly vets these scenarios. Modern advances in modeling software can provide accurate and detailed data upon which you can base your decision.
Conclusion
Your company is making a substantial investment when they undertake a controlled environments project. Whether to increase yields, improve quality, accommodate new processes, products, or research initiatives, the basic rules of engagement remain the same. Following these fundamentals will result in a better project outcome, a smoother project process, and more efficient maintenance over the life of your facility.
Richard Bilodeau’s 30-year career includes plant engineering positions in clean manufacturing. He has designed, operated, and supervised the construction of advanced technology facilities and engineered clean manufacturing facilities for lithium-ion batteries, medical devices, electronics, and pharmaceuticals. Contact: [email protected]
This article appeared in the November/December 2013 issue of Controlled Environments.
