6 BioPharm International
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Manufacturing and Facilities 2022 eBook www.biopharminternational.com
Automation
needed. In addition, it is likely that the technology or
infrastructure needed is not in place for this automa-
tion solution to be implemented, which can lead to
even more work for the engineering and automation
companies—and additional costs for the end-user.
This rework and potential downtime for the machin-
ery required while changes are made can also com-
promise data and operational integrity. Thus, when a
gap in technology or automation efficiency is noticed,
it requires immediate attention.
Bringing back the engineering company, original
equipment manufacturers, sof tware vendors, and
end-user stakeholders to consult on the project is not
only greatly inefficient but costly. What if the project
took a different approach? The selected engineering
and automation companies should collaborate from
the planning and design stages of a project all the
way through to the commissioning and qualification
phases. This approach results in a more efficient, re-
liable, and modern design that is developed far faster
than the traditional method.
The right people in the room
Some of the most successful companies in starting up
or maintaining single-use facilities often share a com-
mon first step—getting the right people in the room
early. At the beginning of a project, it is crucial that
a representative from the end-user define the vision
for the facility in its entirety. From engineering to
manufacturing startups, this vision will help outline
expectations, requirements, and a strategy for future
development. The vision may involve management
of inventory in bag bins, active control of automated
pinch valves, or preventative maintenance analytics,
but it always requires multiple team members with
different skills to realize this vision. The right rep-
resentatives from an engineering, procurement, and
construction (EPC) company and an automation sup-
plier also need to be involved early to allow for better
knowledge sharing between the parties to positively
inf luence the facility's strategy and build the best
solution for the end-user.
Early discussions are used by an engineering team
to translate the end-user's vision into a design basis
that describes the f unctionality, device selection,
map of the operational footprint, and how the pro-
cess is being controlled. This effort usually requires
a system integrator to be engaged who must work in
parallel with the engineer to define control method-
ologies, document system requirements, code, define
testing plans, support installation efforts, interact
with software vendors, and so on. When these steps
are not performed in parallel, delays or rework are
common results. In addition, multiple vendors are
commonly involved with different unit operations in
biotech facilities, which means navigating competing
priorities. The sooner the collaboration can begin, the
better chance that standardization is realized across
the project. Standardization is especially vital to better
support employees who work with and maintain the
equipment and technology day in and day out. Stan-
dardization is also important for facility-wide system
integration between the equipment and higher-level
manufacturing systems. Without it, data can be ren-
dered unusable if it is incompatible with other infor-
mation being collected or it cannot be synchronized to
offer visibility and insights into full operations. Stron-
ger and earlier collaboration leads to the adoption of
standards and, in turn, more useful data.
Keeping data integrity and extensibility in mind
Even if the right people are in the room to begin the
single-use facility project, tight deadlines and multi-
ple stakeholders can make it hard to manage priorities
and make sure the facility design will meet expecta-
tions and pass the qualification process. As planning
starts, there are two important considerations to keep
in mind: data integrity and extensibility.
Perhaps one of the most important facets of data
integrity when collaborating with multiple vendors,
complex equipment, and critical data is cybersecu-
rity. Typically, the more data that are generated, the
more security is needed. In the early stages of plan-
ning, vendors may come in offering a new way to
monitor reactors, but they might not consider that the
camera they are suggesting would generate massive
amounts of data that need to be stored efficiently and
More on single-use systems
Visit BioPharmInternational.com to read more on
single-use technologies including the following:
• Specialty Polymers Add Value
to Single-use Technologies for
Biopharmaceutical Processing
www.BioPharminternational.com/view/
specialty-polymers-add-value-to-single-use-
technologies-for-biopharmaceutical-processing
• Addressing the Training Gap
for Single-Use Technologies
www.BioPharminternational.com/
view/addressing-the-training-gap-for
-single-use-technologies
• Large-Scale Single-Use Bioreactors
Can Maximize Long-Term Scale Up
www.BioPharminternational.com/view/large-
scale-single-use-bioreactors-can-maximize-
long-term-scale-up
