The Incompatibilities of Semiconductor and Life Science Cleanrooms

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Oct 20, 2010

There are distinct differences in the basic design criteria between semiconductor and biopharma cleanrooms — starting with the floors, ceilings, and walls.

As the CEO of a cleanroom room design/build company, a turnkey service provider for the life science industries, I’m frequently asked, “So, how’d you get into this?” And the answer is always the same — a long-winded monologue on how I started my career in the mid-1990s working for a subcontractor in Silicon Valley and how, due to a shift in capital expenditures, I was motivated to make a move away from semiconductor and focus instead on biopharmaceutical and health care. The not-so-subtle theme of follow the money always raises eyebrows and gets the slow but affirmative nod of approval, but what seems to get lost in translation are the reasons why such a move was necessary; that is, there are distinct differences in the basic design criteria between semiconductor and biopharma which make the engineering and construction of their cleanroom environments a mutually exclusive process.

For years, I witnessed cleanroom vendors and contractors grossly cannibalize semiconductor products in unsuccessful attempts at creating acceptable life science systems. It’s fair to say that the lack of understanding by professionals on all sides of both industries — designers, manufacturers, contractors, and end users — have slowed the process of innovation. It has resulted in many companies accepting products that don’t perform to the highest standards which have ultimately increased costs and slowed production.

The most commonly understood element of their incompatibility is in the contrasting nature of their exposed surface materials — the floors, walls, and ceilings. This is due to the obvious fact that the performance criteria of the architectural surfaces in a semiconductor facility are completely opposite to those in a life science laboratory. A somewhat typical semiconductor facility will have a combination of raised access floors with perforated tiles to achieve laminar flow; a modular (demountable/non-progressive) aluminum-based cleanroom wall system with electro-static dissipative properties; and any number of rod-hung aluminumbased ceiling systems, either stick-built or pre-fabricated plenum modules. In contrast, the prototypical life science laboratory has a single purpose: to eliminate the potential of microbial contamination of the end product. And therefore, the architecture itself is strikingly different from its semiconductor counterpart, as it’s designed to perform in a wash-down setting. The flooring in a life science environment is normally a resinous type with trowel coves for ease of cleaning; the walls tend to be of a seamless make-up, either epoxy paint or welded PVC laminate; and the ceilings are constructed as part of the same seamless transition into the walls, yet, in most cases, they have the added “walk-on” feature which allows serviceability and maintenance from the interstitial side without compromising batch production.

And so the phrase “homogeneous environment” can be fittingly applied. This is to suggest that a truly aseptic condition is created by designing and building the ideal state of sterile preparations (health care) and sterile manufacturing (biopharmaceutical). The most acceptable, and practical, method of doing so is to construct an encapsulated room in which the floors, walls, and ceilings become one entity, a concept of monolithic surface consistency with an unvarying seamless finish. In addition, the exposed surface material should be of a type that is resistant to both aggressive sanitizing agents and the routine impacts of material transfer. These types of systems are implemented in order to ease the labor of cleaning while ensuring the process of sterilization is foolproof.

Semiconductor facilities, to the contrary, are anything but homogeneous, yet they have demountable features that add flexibility to the manufacturing process that life science facilities can simply not implement. The hallmark of the semiconductor architectural cleanroom blueprint is the post and panel modular wall system; that which is seen in most bay and chase configurations. This combines an extruded aluminum structural stud and batten system (either anodized or powder-coated) which acts as the framing mechanism for the cleanroom wall panel, most typically a ¼" thick, four-foot wide composite panel made up of an aluminum honeycomb core sandwiched by two aluminum sheet skins with a factory-applied polyester roll-coat finish. Depending on the specification of the particular process, it’s not uncommon that the honeycomb panels and the framing system will be required to be coated with a static-dissipative paint, as the build-up of electro-static discharge (ESD) significantly affects production yields, manufacturing costs, product quality, product reliability, and profitability. The aluminum post-panel-batten configuration is the conventional model of a front-loaded assembly that is mechanically fastened with an air-tight seal to maintain the specified pressure drop yet has the ability to be demounted and reassembled by nondestructive means.

As value added as these modular and demountable features are to semiconductor facilities, they are fundamentally not acceptable within the regulations of cGMP (current good manufacturing practices) in which biopharma manufacturing must comply. Constructing a functionally demountable wall system — a body of components that are designed for the sole purpose of deconstruction and reassembly — is, by nature, contrary to the homogenous, encapsulated, and monolithic surfaces that make life science facilities aseptic. There is a basic reality in play: in order to reduce conditions that harbor microbial contamination and growth, a consistent, smooth, and cleanable exposed surface must be implemented and such a system cannot exist that also has functionally demountable features. This is not to say that the life science industry does not have a list of architectural modular wall products that are marketed as “demountable” and “non-progressive” — but, again, demountable only after a destructive process that compromises the pristine integrity of the original installation. And when the integrity of a life science facility is compromised, the potential of a tragic event becomes a possibility. In semiconductor, contamination effects yield which is an issue of property and casualty. In biopharma, contamination affects people which are issues of life safety and public health.

As the differences between the types of products used in these two industries are glaring, there are some current situations that are bringing them together. The inevitable result of the shift in capital from semiconductor to life sciences is a growing number of high-tech facilities being closed, leaving many state-of-the-art cleanrooms in use but unoccupied. One example is Seagate Technology, who, in September 2008, made plans to close its newly built research facility in the Strip District of Pittsburgh, Pennsylvania. Seagate, which is based in Scotts Valley, California, moved into this $40 million complex in the summer of 2002. Seagate’s decision to close the site was quite painful to Pittsburgh’s burgeoning high-tech sector, as Seagate is the world’s largest maker of computer hard drives. Seagate occupied four floors of a six-story building — or 160,000 of the 200,000 square feet of space in the building, often working in conjunction with Carnegie Mellon University. The problem now is that Seagate, like many other companies who abandon a location, is still under a long-term lease and they are incurring immense costs to let the building sit idle. Seagate’s building is in a prime location and it has an abundance of seemingly brand new hightech laboratories, so the original thought process was that it wouldn’t sit vacant for very long. But unfortunately, the Seagate building faces an obvious hurdle — it’s a semiconductor facility in a life science town. Pittsburgh, widely renowned for it’s innovations in heath care, and with a growing research community in biotechnology and tissue engineering, isn’t likely to attract the high-tech sector needed to occupy a building of this size. Which leaves Seagate with what may be the only viable option: modifying the spaces, as needed, into aseptic cleanrooms and laboratory environments to attract a life science or R&D clientele. As opposed to futilely waiting for tenants who just don’t exist, the practical step would be to adapt the space to meet the needs of the industries in place. This is a far better strategic move in times of economic scarcity as it creates a platform for Seagate to lease commercial real estate to both sectors.

But not all semiconductor companies are trending toward aseptic cleanrooms out of necessity; some are doing it by choice. One example would be that of ATMI, Inc., a company who recently announced a global plan to double its production capacity of ultraclean, disposable bioprocess vessels. To do so, ATMI will quickly upgrade and modify their North American manufacturing facility in Bloomington, Minnesota in the exact model of the ATMI Life- Sciences plant in Belgium. They will create a Grade B cleanroom for fabricating complex three-dimensional storage, mixing and bioreactor vessels for their life sciences customers while maintaining its foothold on the integrated circuit (IC) and flat panel display (FPD) markets. Furthermore, the upgraded facility will house a bio-burden analytical lab and manage sterility levels in the manufacturing environment. With these modifications, ATMI continues to capitalize on its command in semiconductor production while wielding much needed expertise in ultrapure manufacturing.

And thus, it seems, as the global economy forces companies to redirect capital expenditures more efficiently, the real winners of the next decade may be those companies who, although historically successful in the semiconductor sector, recognize the opportunity to re-design and renovate their manufacturing footprints to address the rapidly increasing demands of the biopharmaceutical industry. Through a higher level of understanding — that is, a greater knowledge of the required products and how they are best applied — the semiconductor and life science industries should experience a confluence of innovation and growth.

Deric Haddad is the CEO of Haddad-Wylie Industries (Pittsburgh, PA) established in 2004. Beginning his cleanroom construction career in the Silicon Valley, CA, Deric worked on some of the largest projects in the semiconductor industry. In 2003, Deric noticed that the capital expenditures were being heavily weighted toward the Life Science Industries and began his own company with this in mind. Haddad- Wylie Industries has high profile clientele in the cleanroom industry and truly aseptic cleanrooms.

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