ecosystems from any hazardous chemicals effluent. These
requirements are likely to vary between products and processes, may differ according to the facility’s location, and will
need to be built into the specifications.
Moving from design to model
Once all the user specifications are in place and approved,
the next step is to build a three-dimensional model that will
eventually be used to create the construction drawings. This
step, known as 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, as well as specifics and quantities of building materials and components. Setting out clear definitions of the levels
of development, a reference can be used to specify the content
and reliability of building information models at different stages
of the design and construction process. It will also help all users
understand the usability and limitations of the models created.1
Creating a model with this level of detail is a time-consuming process, and the tools required to create the detail
are, at times, not efficient. Improved design platforms and
additional interface technology are in development, which
will make this step more efficient.
Typically all of the project components need to be modeled individually before they can be used in the BIM process.
Once the model has been created, even the smallest changes
in components—for example, switching a valve used as a
placeholder for the one wanted in the finished fabrication—
can have quite a major impact. It may even mean a complete
redesign of a section of the model, leading to delays downstream, from planning and costing materials required for
construction, to gaining approval to begin fabrication.
As standardized components become more commonly utilized,
there is almost always the need to make changes throughout the
process, which demonstrates the need for an early focus on selecting the right components early in the development of the project.
Clients, designers, and contractors need to collaborate closely,
working with clear guidelines and detailed project plans throughout the process, and particularly in this phase. They also need to
recognize that each has different skills, strengths, and weaknesses,
as well as different perspectives on the issues. Even more so, each
has an interactive role in challenging what is and what is not
needed, through clear, open, and transparent dialogue.
The next move: model to installation
Once the client and the designer sign off on the model, it is
then handed on to the contractor, and the next step is to create the fabrication drawings and get approval to begin work.
This requires a set of shop drawings to demonstrate that
the design was fully developed, and the contractor built the
cleanroom component(s) to the design requirements.
The cleanroom unit operations can be prefabricated off-
site as modules/components (often on stainless steel skids) in
a dedicated hygienic fabrication facility and moved into place,
or built in place on-site (stick-built). The choice is dependent
on the requirements for the cleanroom, the timelines, budget,
and the need for flexibility during the installation process.
Generally, smaller process systems/components are built
remotely, factory-tested, and then shipped to the site. This
can include a wide variety of process unit operations such as
bioprocessing, filtration, centrifuge, separation purification, or
aseptic unit operations. Using prefabricated modules with little
customization means a facility can be up and running much
faster (and therefore generating revenue more quickly). It does
not rely primarily on sourcing local qualified labor; ensures
the most cost-effective and efficient use of time and resources;
and reduces the number of people needed on the construction
site. Fewer people on-site can also improve on-site safety and
help to maintain the cleanliness of the facility by reducing the
opportunity for contamination.
If the same design can be implemented over a number of
sites, this makes staff training easier and allows people to be
moved from site to site with little downtime. It can also make
troubleshooting easier. However, it is more expensive than
building on-site, and there is less flexibility for change.
Building on-site is implemented when the building struc-
ture is used to support, and is integral to, the equipment.
This approach is used for very large systems that would be
impractical to build off-site, and can be a more flexible pro-
cess; however, it takes longer to develop.
In the end
Whether the units are fabricated on- or off-site, it is important
to ensure that clean principles are maintained throughout.
This approach will mitigate risk of operational failure(s).
Throughout fabrication (and in some cases, shipping) and
installation, the team will need to implement and maintain a
clean development process, including keeping construction
components and areas clean, and for personnel to wear appropriate protection for cleanliness.
During the design, build, and installation process, the
paperwork that tracks the components and materials used,
and monitors the quality of the installation (for example,
inspection and product records for weld pressure tests)
The ASME BPE Standard
The ASME bioprocessing
equipment (BPE) standard
provides details of best
practices for the design,
build, inspection, testing,
and certification of equipment used in the bioprocessing, pharmaceutical,
and personal care products
industries. Its aim is to
ensure product purity and
safety, and according to
the ASME, “companies that
rigorously apply ASME-BPE often can achieve
lower development and
manufacturing costs, and
increase quality and safety,
while complying with
regulations.” 2 The ASME
BPE standard was created
as a consensus standard
across the industry, and
provides a harmonized and
objective approach for the
and installation, the team
will need to implement
and maintain a clean