An efficient, safe, and cost-effective cleanroom is often vital to the manufacturing process for therapeutics, particularly biologics. Strategic planning, practical design, and careful fabrica- tion that build in the aspects of “clean” from the
very beginning all contribute to the creation of an environment that is easy to maintain and operate.
While the concept is fairly straightforward, the actual process of building or renovating a cleanroom is anything but.
It requires alignment between the client, construction, and
design team, and an open line of transparent communication.
Designing in the concept of ‘clean’
The primary role of a biopharmaceutical
cleanroom is to safely and effectively
produce products for people. Closely
aligned with this role is the need to
protect operators from contact
with certain ingredients, excipients, and other compounds,
such as powders used to make
up buffers and media. A
cleanroom arrangement and
adjacency can mitigate contamination between one production line and another, reducing
the risk of cross-contamination.
To build a space that is clean, the
design and construction teams need
to first understand the user require-
ments of the project by developing user
requirement specifications and becom-
ing familiar with the entire process. This will enable personnel
to fully realize the manufacturing process, from the arrival and
storage of the drug manufacturing components through to the
packaged products leaving the building. It is also important to
know how those working in the space will interact with each
other and with the equipment, which drives effective ergonomic
design. Knowing the timelines, cost targets, and expected product
ROI (or NPV) will also be important. All of these aspects affect
when a manufacturing facility needs to be finished; for example,
to accommodate a planned project launch. It also helps determine
the workload and turnaround time for each production line.
Creating the specifications
The specifications for the build of cleanrooms—for example,
the type of piping or the use of modular units—are driven
by guidelines such as good manufacturing practices (GMP),
as well as the ASME bioprocessing equipment (BPE) standard (see sidebar). Specifications for the cleanroom will also
vary from customer to customer.
Using high-purity process piping as an example, what the
pipe needs to carry and where it is located will drive
its specification, as laid down in the ASME
BPE standard and other guidelines.
These sources include the pipe’s
mechanical and chemical proper-
ties; its internal product contact
materials (including their
traceability); external coating
and surface finish; and how
the pipe is connected to other
equipment as well as how it
is attached to the cleanroom’s
superstructure. The welds that
connect pipes are also covered by
the standards; for example, welds
must create a smooth and cleanable sur-
face on the inside and the outside of the
pipe. There are also specifications for the
alignment and the profile of the weld.
The specifications for the layout of
the piping will be influenced by the client’s needs, and the
ergonomics for the operators. As this part of the project can
be a significant amount of the cost of the installation, the cli-
ent needs to define requirements as early as possible, in col-
laboration with the designer and contractor.
Environmental concerns are increasingly important, from
the perspective of reducing the carbon footprint of a facility to managing energy usage, as well as protecting the local
Best Practices for Building
a Clean Environment
From specification to installation, clients, designers, and contractors need to
collaborate closely and establish clear guidelines and detailed project plans.
Building information modeling (BIM) includes not only
the three-dimensional geometry of the building and its
contents, but can also include time, cost, and maintenance information. (All images courtesy of M+W Group)