The design of a cleanroom should be a well-orchestrated collaboration of many disciplines to create a product-specific functional space. As one discipline, we, as architects, are trained to look beyond the technical requirements and consider the aesthetic and human element of all spaces, including the cleanroom. We attempt to blend these functional, aesthetic, and humanity considerations into cleanroom design.
In the last century, an influential French architect named Le Corbusier published a somewhat radical manifesto in his 1923 book Vers Une Architecture (Towards a New Architecture). He wrote “a house is a machine for living in.” Throughout my architectural career (which has included the design of many cleanrooms), the idea has resonated with me, though I have paraphrased in my mind to say “a cleanroom is a machine for production.”
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With that in mind, designing cleanrooms requires both architects and engineers to recognize that they are a complex means of production – often resembling a living, breathing, growing organism more than a machine. This is partly because cleanrooms are constantly changing. Sometimes the changes are minor (e.g. tweaking the airflow); other changes are more robust (e.g. making spatial modifications, replacing the air handler, process equipment, or the product). If executed with care, both minor and major changes can enhance the room’s productivity.
Knowing the ever changing nature of cleanrooms, designing for flexibility becomes the key to long-term return on the investment of a clean space. Even though the user requirements of these spaces can be multifaceted and pose unique challenges to a designer, there are simple design considerations that we, as architects, can use when assisting our clients to achieve the best operating outcomes in such a space.
Do you really “need” a cleanroom?
A cleanroom or suite of cleanrooms is, hands-down, the most expensive space to build and operate in a facility, so deciding to build one is not a decision to be taken lightly. Once operational, it should run as reliably and consistently as possible; when it’s not operating, your business isn’t making money. Appropriate design to address these concerns is crucial to minimize facility downtime and maximize optimal operations.
The first thing we, as architects, can help our clients understand is whether or not a cleanroom is truly a requirement for their facility. Beyond the technical or product/personnel safety interest of providing a cleanroom, there are often other, softer reasons that a client may say they want a clean space. In my past experience, I’ve had clients request cleanroom environments for the sake of elevating the comfort level of their clients who may be touring the facility. Requests have even been made similar to this: “We want the material, finishes, and look of a cleanroom, but we aren’t going to certify or validate it.” These can all be valid reasons to design a clean space – sometimes, perception is reality. But the question still remains concerning the regulatory, functional, or technical necessity of a cleanroom.
There are also wide swings in the eye of the beholder of what constitutes a cleanroom in the first place. We have all been in facilities that rely on an inordinate amount of Personnel Protective Equipment (PPE) and Standard Operating Procedures (SOPs) and operate without much infrastructure to support the requirements of clean spaces. Other buildings with more sophisticated operations typically do not rely as much on these precaution protocols.
Client opinions are just as varied as their appetites for cleanroom design. It’s important to bring to the drawing board all facility stakeholders during the programming phase of a project; Management, Quality Compliance and Assurance, EHS, Engineering, Maintenance and Operations should all be involved to add their input and ensure their needs are addressed.
Several of my facility design colleagues have spent years working to precisely understand the regulatory and technical process requirements of clean production spaces in the biotech and pharma industries, with the intent to reduce or eliminate unnecessary cleanroom spaces. This is not an easy feat and is not without resistance, but if we can determine (through facility and process modifications, improvements, or innovations) that we can eliminate or reduce some of these clean spaces, our clients can reap significant operating cost savings.
Such reduction of clean space and space declassification ideas are at the heart of CRB’s FutureFacility concept that we began to discuss and consult on nearly 10 years ago. Still relevant today, we are frequently charged by our clients to challenge what the required cleanliness of a cleanroom actually is. In the biotech realm, the advent of employing closed systems has allowed us to begin to declassify or reduce air changes with a keen interest to reducing the cleanroom environment footprint. In the pharma side of the industry, hot topic discussions are centered on continuous processing, which is posited to boost manufacturing efficiency but would also attempt to reduce the amount of clean space required in a facility.
Ultimately, with the advances in the biotech and pharmaceutical industries and beyond, a keen analysis should be performed to determine if and to what degree a cleanroom is actually required for your facility. Engaging in such an exercise is the best way to save yourself time and money before you make the capital and ongoing investment.
Collaborative cleanroom design means flexibility
If analysis confirms that a clean space is required, then the appropriate technical and programmatic tools should be applied to the design process; collaboration of various disciplines and stakeholders is absolutely required. First, as architects, we need to know that there are crucial programmatic differences between the various industry sectors that use cleanrooms (I was once a consultant on a case where these subtle distinctions were apparently not known by the designer or owner, and a multi-million dollar lawsuit was the result). Just as a train is a “machine for transportation” of persons and materials, there are still specific variations to meet specialized transportation needs. We wouldn’t use a coal car to haul passengers.
Once the industry requirements for your cleanroom are established, we must work hand-in-glove with process engineers to create spaces that meet the specific needs of the room, and then expand design considerations to the various support spaces and functions throughout the entire facility design.
The high installation and operating costs of cleanrooms can tempt clients (and designers) to “shrinkwrap” the layout around the process equipment. Unfortunately, this short-sighted approach can introduce hidden costs that have long-term effects on flows, efficiency, and personnel. Additionally, what is often neglected in the initial planning for a new cleanroom is a look into the future. With only nominal foresight, the complete lifecycle of the room and/or facility can be projected; i.e., after the initial functional use of the space has been exhausted, there is usually a renovation/addition or series of renovations/additions that occur. Thoughtfully planning for these future facility changes during the initial planning of the cleanroom can significantly reduce the cost or even eliminate the need for the renovation altogether – an approach that could contribute to a more sustainable facility as well.
Therefore, from an architect’s point of view, designing a flexible cleanroom that can be used for 20 years with minor modifications (as opposed to a more stagnant one used for 3 to 5 years, then repurposed with major modifications) is something we can and should encourage our clients to take into account in early feasibility and conceptual planning.
Process = programming
One of the more obvious elements of cleanroom design is an efficient layout based on the programmatic needs of the process. As mentioned earlier, an understanding of the program is essential to meeting the client’s user requirements.
Many who are involved in cleanroom design will know the major differences between a biotech space as opposed to a microelectronic space. For those spaces with heightened biocontainment requirements, one of the primary focuses is on personnel protection and containment of microorganisms. Properly locating the containment barrier within the architectural and decontamination equipment elements can be challenging. A good knowledge of the NIH BMBL document helps with the general approach to facility design, although it is not particularly very detailed in its description of architectural solutions.
In the more controlled microelectronic spaces, the requirement is to prevent particles from attaching themselves to wafers, etched chips, or sensitive research equipment, etc. This approach requires much more filtering of the air and plenums under a raised perforated floor to help create a more laminar airflow. These low particle count requirements sometimes reduce the particle count down to 1 per cubic foot of air volume. That would be cost prohibitive in most biotech and pharmaceutical production areas, where 100 particles per cubic foot is considered very clean. Although in the pharmaceutical sector, particularly in an oral solid dose facility, we are also concerned with occupational exposure limits (OEL) from product particles being liberated into the space (a problem often solved by integrating a restricted access barrier (RAB) into the architecture).
Where sterile environments are required, there are various levels of cleaning needed for equipment and product containers. A knowledge of washing, filling, lyophilizing, and capping processes help guide design decisions for those types of programs.
Understanding of the programmatic requirements of a cleanroom is essential for an architect. Understanding the design process for one cleanroom and/or a comprehensive cleanroom-based facility assists in executing a cost-efficient project. Best practices for laying out and constructing an efficient cleanroom or suite of cleanrooms consist of many of the following items:
1. Maintain one-foot partition thicknesses until conceptual planning is complete. This allows space for flush: low wall returns, utility panels, MMI panels. Keeping the one-foot dimension in the early design phases will also allow you to shift some partitions so they can get deeper and others to get shallower without having to shift all the partitions within a suite.
2. If designing a complete facility, design the cleanroom modules from the inside out to assure the correct space allocations and flows.
3. Establish efficient hierarchies of space in the facility for services and utility zones both vertically and horizontally. This could include interstitial spaces above or parallel utility corridors.
4. Establish accurate and efficient spatial hierarchies for ingress and egress zones, circulation, containment, etc.
5. Select the appropriate compliant airlock or transitional spaces ingress and egress out of clean areas.
6. Early decisions on the cGMP SOPs for airlocks and flow directions drive room layout sizes and facility circulation square footage.
7. Try to keep partitions aligned and straight for all runs so that the construction layout of the facility will be more efficient. This will also allow for more efficient and less expensive runs of services within the partitions. Corners cost money.
8. If there are a large scale tanks and/or IBCs moving through the facility, the following should be taken into consideration:
a. The safe transport of hazardous materials in approved containers
b. Correctly specified material handling equipment needs to be defined early so that the corridors are sized properly.
9. It is crucial to define (if necessary) how the interstitial space should be configured to give the most efficient runs of utilities thru the facility. There are code implications to that space and it may not be able to be considered a mezzanine from a code point of view.
10. The team should consider the sectional elevations of the building and not reduce the vertical clear dimensions too low.
11. A consideration of the use of a pipe bridge that runs strategically through the facility and could either be supported from the roof or the floor below will help organize utility runs.
12. The use of a penthouse may help with maintenance of equipment usually exposed to the elements, but there are area limitations and are usually not big enough to house everything that needs to go in them. Although, a second floor or a penthouse might take some of the footprint off the mechanical space.
13. It is important from a detailing and operations perspective to try to keep the hazardous separations at the perimeter and preferably at a corner of the facility so that only two perpendicular fire walls are required. They are expensive. Those walls should be straight and should follow through to the interstitial space.
As architects that specialize in high value technical facilities, we must be fully integrated with all other disciplines and stakeholders in the art and science of clean design. This type of collaboration can result in cost-effective, sustainable, and healthy “machines for production.”
Robert Rice, RA is Architectural Practice Lead at CRB, headquartered in Kansas City, Mo. www.crbusa.com
This article appeared in the March 2015 issue of Controlled Environments.