and technical process
requirements of clean
production spaces in
the biotech and pharma
industries, with the intent
to reduce or eliminate
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.
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 “
shrink-wrap” 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
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
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
Flexible pilot scale clean
space. Courtesy of CRB.
Sectional study for
multilevel clean space.
Image created by Patrick