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
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
of the facility will be
more efficient. This
will also allow for
more efficient and
less expensive runs
of services within the
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
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
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
Bio Tech spatial planning
diagram. Image created
by Robert Rice, CRB.