Medical Design Briefs - July 2021 - 11

tomized to fit the available space as well as to accept different
container sizes and configurations.
Because the volume of each reagent is different, the ability
to handle containers of various sizes was important, says Dunn.
The process involves multiple reagents. This might involve 5
ml of reagent for one aspect of the test, 9 ml for another, and
125 and 250 ml bottles for others.
Despite being customized, the system was easy to use out of
the box, allowing LuminUltra to quickly begin dispensing liquids
with the needed volume and accuracy. Dunn says he also
appreciated the single-use technology, precision liquid filling
equipment, and the manufacturer's willingness to consult and
provide expertise throughout the process, which he views as
vital for a successful implementation. This involved optimizing
the process by providing input on operator selection, training,
and production flow.
The system can also be easily reconfigured to accommodate
a range of fill volumes, dispense profiles, containers, and closure
types. Custom-designed component parts are also available
utilizing in-house design and 3D printing, as needed.
According to Dunn, that kind of flexibility facilitates line
expansion in the future and would make scale-up easier when
LuminUltra is ready for it.
Gentler Dispensing of Biologics
In addition to dispensing a variety of liquids, filling equipment
is also increasingly being used to dispense sensitive biologics
manufactured by or extracted from living sources - typically
proteins, cells, nucleic acids, viruses, or vaccines.
In recent decades, protein-based therapeutics have become
increasingly important to the pharmaceutical industry. These
biopharmaceuticals are costly, difficult to produce, and susceptible
to physical degradation when subjected to high shear
forces during dispensing.
In fact, biologic products can degrade when dispensed using
peristaltic pumps. These pumps contain fluids in a flexible
tube, housed by a pump casing. A rotor outfitted with a system
of rollers compresses the tube as it turns to create continuous
fluid flow. However, the pump's shearing force is not conducive
for live cells, and its rollers can gradually damage the
tubing, causing it to wear and stretch over time. The shearing
force can even potentially release or shed small quantities of
tubing material into the liquid as it flows.
The alternative to peristaltic pump technology is a hybrid
pump design that is gentler and more reliable when dispensing
biologics. Because liquids in the pump are not squeezed by
rollers, there is no opportunity for cultures or delicate specimens
to be harmed as it flows through the tubing. In terms of
accuracy, this hybrid pump-based filling equipment delivers
repeatable liquid filling accuracy ≤0.5 percent of the intended
volume. In comparison, conventional pump accuracy is usually
within 1-2 percent.
Whether life science companies are in basic R&D, developing
the product, or rapidly scaling up through clinical studies
to full scale GMP manufacturing, utilizing a modular, singleuse
liquid dispensing systems that can be scaled up to meet
increasing production demands can be a tool to achieve
greater production efficiency, flexibility, reliability, and profitability.
This
article was written by Barbara Biller, President of intelliTECH,
Inc., manufacturer of custom liquid fill and finish machinery. For
more information, visit http://info.hotims.com/79415-341.
Medical Design Briefs, July 2021
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Medical Design Briefs - July 2021

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