Thursday, February 3, 2011

Modular Cleanrooms

Mary Williams
Advantages,Trends, and Developments
There are many companies who are directly involved in manufacturing modular cleanrooms. I asked a few “experts in the field” if they could take some time out of their busy schedules to talk with me about what some of the advantages, trends, and developments may be in the modular cleanroom arena in the coming year.
I started my discussion with: What varieties of modular cleanrooms are available? The majority answered, as you may have guessed, hardwall and softwall. In further discussion, it is clear that there are a myriad of modular cleanrooms ranging from being built onsite, to portable containers being shipped to a site. Many of the contributors referred to the air design as one of the driving forces to determine what type of modular cleanroom would best suit the needs of clients, while others cited the ease of adapting the modular cleanroom to different solutions within the same company as the advantage.
What are the advantages to using modular cleanrooms?
The answers to this question highlighted the ability of a modular solution to save time and money while offering the possibility of creative solutions in design and planning.
Bryan Leisure, of United Partition Systems, Inc., stated, “Modular cleanrooms offer flexibility and can be easily expanded or upgraded which is a huge advantage for clients that may have minimal downtime.”
Jelle Hanse of Clean Modules Ltd. said, “As the main elements of the modular cleanroom solutions are prefabricated away from site, on site construction can be completed more quickly.”
“Pre-engineered, prefabricated components reduce the need for interruptions of various skilled trades that are typical in conventional construction. This keeps construction schedules compacted and reduces the time lost in sequential mobilization of specialized trades groups as a construction project progresses.” added Ron Kosmalski of Clean Air Technologies, Inc.
Kevin Weist, of Clean Air Products offered that a prefabricated modular cleanroom is ideal for expansion or renovation projects for existing, occupied facilities since it removes the debris and staging issues associated with conventional methods and reduces the potential for interruptions of ongoing activities.
Another advantage, according to Hanse, is that “modular cleanrooms can be extremely beneficial to projects with restricted site access. As modular units are transportable, they can be lifted into any location—within enclosed courtyards, on top of another building, or an open area. This enables cleanrooms to be constructed in locations that may have been ignored when considering a more traditional cleanroom facility.”
In addition to physical advantages, there are monetary ones as well—modular systems depreciate much faster than conventional construction enclosures. As noted by Kosmalski, “depending on geography and tax incentives, modular cleanrooms frequently qualify for rapid depreciation and other tax advantages.”
In addition to a possible tax advantage, what solutions can you suggest to small facilities working on a limited budget?
“Cleanrooms are versatile and can be used in many different ways and situations. The most suitable solution may not always be known to the customer, but can make a difference to the effectiveness and efficiency of the cleanroom facility,” said Hanse. “There are various cleanroom solutions available to match different demands, sites, and customer requirements.”
Most agreed that since small companies are less likely to be able to overcome delays and cost increases that could plague a complex controlled environment project, it is recommended to hire a professional modular cleanroom team. In almost all cases, a modular cleanroom can be completed much more quickly and inexpensively than a conventional building.
When planning, Weist noted that it is important to pay particular attention to “the location, the size, and the class of the room, and pay attention to the temperature and humidity that the room will require.”
Mike Buckwalter of Terra Universal warned “sophisticated modular rooms can, however, escalate in price if a project isn’t managed properly. It is of the utmost importance to understand and communicate all application requirements clearly from the moment a project is undertaken.”
“Challenges arise when a customer leads in the direction of a low-cost solution like a softwall cleanroom, only to discover later that unmentioned considerations (like containment) require substantial and expensive re-design or (worse) an entirely different approach. The low-cost room turns very expensive when you learn that it’s unusable because it doesn’t meet BSL requirements, or can’t be sterilized with the preferred disinfectant” added Buckwalter.
The lesson here is that owners of small businesses should insist on hiring a proven team with an established track record.
What trends do you expect to see in modular cleanrooms in the next few years and how will the controlled environments industry’s use of modular cleanrooms change?
Hanse replied, “More and more customers are going down the modular route as they recognize the benefits of modular cleanrooms. Over the past few years various modular cleanroom facilities have been constructed and they have proven that the modular facilities comply with regulations, are more cost and time efficient, and offer more versatility, yet give the comforts of a traditionally built cleanroom facility.”
“A trend destined to continue will be the do-ityourself advocates,” noted Kosmalski. “As catalog shopping and cleanroom industry forums emerge on the internet, many skilled or emboldened construction personnel are optimistic at the prospect of learning the principles of effective contamination control, and keeping the production in-house. Since several catalog companies offer hundreds of diverse products intended for use in cleanroom construction and operation, some managers are willing to empower their staff to accept the challenge of new endeavor.”
According to a recent article in Controlled Environments Magazine, there are still some projects best left to the experts. Cleanroom design and construction is one of those expert projects. Building a cleanroom is an engineering specific field and requires a qualified cleanroom designer and cleanroom construction manager. The cleanroom project must be coordinated from start to finish, or disaster may ensue. One way to avoid this is to have one single, well-qualified cleanroom contractor to integrate and coordinate the entire process and take responsibility for the final outcome to ensure a successful project.1
Buckwalter said that “in many fields, another trend surfacing is that operations are becoming increasingly sensitive to particle contamination over time. This has been the case particularly in semiconductor manufacturing, where “kill size” particles rapidly fell from one to 0.5 to 0.3 microns and smaller. In that industry, it made sense at some point to move humans out of the operation and encapsulate processes, using human/machine interfaces (from glove ports to joysticks to screens) where necessary.”
Weist noted a number of trends in modular cleanrooms that he sees surfacing including, “more energy efficiency, spot areas of cleanliness, using return air into the white room, modular configurations that allow faster changing of size and configuration. When a process changes, the room can be quickly changed.”
Most are also seeing more attention to “green” issues: energy consumption, use of recycled or recyclable materials, etc. and the demand for containment technologies as more and more processes are deemed potential biohazards. “That seems particularly true of drug and food development R&D operations,” added Buckwalter.
He went on to note that, “We seem to be moving past the era of large-scale production facilities that ran at high-capacity for an extended time. That was the era of large-scale chip fabrication and pharmaceutical manufacturing. There are fewer and fewer mass-produced drugs or semiconductors made in the U.S. that justify the cost of huge facilities dedicated to a single process. As production cycles shorten and volumes fall, modular rooms should become more widespread.”
What is currently the most exciting development in modular cleanrooms?
For Kosmalski, advances in nanotechnology may be improving the efficiency of filtration which will ultimately change how their air handling systems are configured.
For Buckwalter, it was about where to produce a designer drug, or even how low-volume production in a modular cleanroom could be franchised. They have been involved in many projects that began with one room and then (because of the inherent cost-effectiveness of production in a modular facility) led to multiple modular cleanrooms.
Space is obviously a huge factor when determining a location for a new modular cleanroom. Leisure stated that their company offers mezzanine solutions that allow clients to build up and utilize space that may not have been considered.
Hanse said the latest generation of their modular cleanrooms do not contain any timber elements. This improves the rigidity of the facility and makes the facility feel and behave like a traditional building. With environmental regulations tightening up further, the demand for constructing more environmentally friendly facilities will continue to increase.
How have modular cleanrooms evolved in the past couple of years?
“With advances in the biotech and pharmaceutical markets, modular cleanrooms have the advantage over traditionally built cleanrooms in that they can provide smooth surfaces and radius floor and ceiling trim to be USP compliant,” said Leisure.
Buckwalter commented that “Improvements in designs and protocol to meet the requirements of life science customers, especially those requiring FDA validation, are constantly being made. A decade ago, when a cleanroom was made for a semiconductor company, all you really needed to worry about was cleanliness rating and access requirements. Now you have to advise customers about validation challenges they may face and possibly coordinate with balancing, testing, and certifying companies.”
Is there anything else you would like to add?
In response to the question, many said a key topic related to modular rooms is city permitting.
Buckwalter expanded on this saying that for his company, “Modular cleanroom designs typically do not require external bracing or supports; as freestanding structures, they’re typically easier to install without the need for special permitting. When challenged, they’ve been successful at having them classified as “electro-mechanical equipment” rather than a building subject to city inspection and permitting. Clients choosing a modular cleanroom should be aware of possible complications they may have with local municipalities, particularly if they use cleanroom designs that must be tied to the external bracing or fire suppression or air conditioning systems.”
In conclusion, it can be determined that modular cleanrooms offer flexibility and can be easily expanded or upgraded which is a huge advantage for clients that may have minimal downtime, knowing what the requirements are of your room, and the choice of a well-qualified, cleanroom contractor to integrate and coordinate the entire process and take responsibility for the final project will ensure a successful outcome.
I wish to thank Mike Buckwalter from Terra Universal; Kevin Weist from Clean Air Products; Ron Kosmalski from Clean Air Technology, Inc.; Bryan Leisure from United Partition Systems, Inc.; and Jelle Hanse from Clean Modules Ltd. , for their insight on modular cleanrooms and for taking the time to contribute to this article.
  1. Pollick, George, “Don’t Do It Yourself,” Controlled Environments Magazine, November 2010


Bob said...

"What varieties of modular cleanrooms are available?" There are numerous modular cleanroom applications available. From wafer fabrication rooms to compounding pharmacies, modular cleanrooms can be a solution.

Lorna Croft said...

Modular clean rooms are really so much beneficial and scientific. Properly trained professional is needed for that really. can help us a lot to get one perfectly.