Medical Design Briefs - February 2022 - 12

Single-Use Systems
Customer Collaboration for Engineered Solutions
Trelleborg supported an international biopharmaceutical producer
on an advanced development to address the challenges of using a single-use
system within a bioreactor. The customer wanted to scale up
its bag system to a total volume exceeding 2,000 L. The aim was to
retain the proven geometry and impeller design of smaller-scale systems,
as well as the tip speed and power input per volume.
One of the difficulties encountered with this was the much higher
force that the assembly had to withstand compared with other
smaller - scale bioreactor bags. On a scale-up of this size, the mixer
inside the reactor receives a huge amount of torque. Therefore, the
customer needed a new drive assembly for the mixing technology
inside the bag and called upon Trelleborg to help provide a solution.
Trelleborg experts recommended an entirely new self-contained
unit, designed specifically to the client's specifications. The team proposed
a radial magnetic coupling using an assembly incorporating a
special bearing.
Conclusion
Single-use bioprocessing technology has
gained significant traction due to the rapid
adoption of disposable bioprocessing
equipment by pharmaceutical manufacturers.
These systems help manufacturers save
time and money while minimizing the risk
of contamination. Additionally, pharmaceutical
manufacturers can select processing
materials that limit extractables and
Welded on the bag, the complete assembly, consisting of the radial
magnetic coupling and a polyethylene port, ensures hermetical sealing
between the bag and the external environment, eliminating the risk of
contamination and maintaining a sterile barrier.
The first coupling design with ceramic bearings shipped after only
12 months, with the second design, made of ceramic and polymer
bearings, following not far behind. Manufactured entirely from ma -
chined components, assembly of the scaled-up design was in a
cleanliness -controlled environment.
The radial magnetic coupling proved to be very stable with no rocking
or tilting, even when subjected to high forces. The final design has
a bag diameter of around 4.25 ft and a height of 7.5 ft, resulting in a
complete surface area of around 140 sq ft. Following two years of successful
trials at the beta site that confirmed the biological performance
and mechanical robustness of the new product, the 2000-L
bioreactor bag is now in mass production.
leachables and rest assured that they meet
all regulations by partnering with an experienced
components supplier.
By monitoring the market and staying
in tune with customer needs, components
suppliers can help therapeutic manufacturers
choose the right material for the
right application. When components suppliers
have global reach and material
development expertise, they can demonstrate
a comprehensive understanding of
product applications. This allows them to
collaborate with therapeutic manufacturers
to understand their needs and provide
the best solution.
This article was written by James
Hederman, Product Manager at Trelleborg
Healthcare & Medical, St. Louis Park, MN.
For more information, visit http://info.
hotims.com/82318-341.
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Medical Design Briefs, February 2022
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Medical Design Briefs - February 2022

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