Medical Design Briefs - July 2021 - 10

Liquid Dispensing
product changeovers result in significant
drawbacks to this approach. With
hand filling, some amount of overfilling,
underfilling, or product spillage can be
expected, which can be costly when handling
high-value product. Manual dispensing
and measuring can also lead to
repetitive stress injuries for employees.
In addition, in automated filling systems,
production is traditionally accomplished
with equipment that must be
thoroughly disassembled, washed, and
sterilized between batches. The process
is time-consuming, expensive, and energy
intensive, and it opens the door to
possible cross contamination as well as
occasional control breakdowns.
To address these issues, a growing
number of companies are turning to sterile,
single-use, closed liquid dispensing
systems and kits. These utilize disposable
parts that can be quickly replaced to start
the next fill cycle and expedite production
changeovers. Such systems reduce
the risk of cross contamination since
only the single-use components are in
contact with the liquids being dispensed.
This approach delivers superior,
repeatable dispense accuracy after hundreds
or thousands of cycles, while minimizing
repetitive motion injuries. It can
also be scaled up to accommodate
requirements from R&D to fully automated,
GMP manufacturing.
Single-Use Dispensing
Single-use liquid dispensing has be -
come a trend because of its production
flexibility, streamlined production versus
cleaning the entire system, and relatively
nominal cost, according to Derek
Dunn, P. Eng., Senior Director, Services
and Customer Experience, LuminUltra,
a biological diagnostic testing company
that develops tests and reagents for environmental,
industrial, and diagnostic
monitoring, and is a key supplier of
COVID-19 clinical testing reagents for
the Government of Canada.
In the case of LuminUltra, the company
develops a range of testing solutions.
One of these is its second-generation
adenosine
triphosphate
(ATP)
R&D and at the initial production levels,
continued growth eventually forced the
company to consider increasing staffing
or automating the process. The company
had to decide whether they wanted to
hire more people just for filling. Ul -
timately, they decided to automate the
process and reassign the existing personnel
to other more productive areas.
LuminUltra also sought an efficient
process that minimized any potential
contamination or reagent degradation.
One of the major challenges was avoiding
contamination of the reagents, given
that the introduction of even small
amounts of ATP from unintended
sources would quickly degrade the quality
of the test, says Galpin.
test,
which measures ATP in water across
diverse industries. This requires multiple
liquid reagents in different volumes, dispensed
into containers of various sizes.
Stephen Galpin, Packaging Supervisor,
LuminUltra, explains that when an
existing product line was produced in
lower volumes, up to six operators were
needed to dispense the liquid reagents
using pipettes and to then affix caps and
labels. While this was sufficient during
The i-FILL® Micro Pump delivers repeatable
dispense accuracy to even small fill
volumes for delicate product transfer.
(Credit: intelliTECH)
After searching for a market solution
and reviewing multiple bids, LuminUltra
selected a single-use liquid measuring
and dispensing system that included a
pump from a manufacturer of precision
liquid filling and closure equipment.
Single-use technology minimizes the
risk of contamination by utilizing sterile,
disposable fluid path components from
product source to dispensing nozzle.
Each kit is a complete unit containing
intake and discharge tubing, check
valves, complete pump parts and a dispensing
tip/nozzle. The disposable fluid
path kits are assembled and packaged in
an ISO Class 7 cleanroom and postassembly
gamma irradiated to
eliminate or minimize biological
risk and maintain
microbial control.
Production downtime is
minimized, and changeovers
are accelerated by
eliminating the need to
disassemble, clean, sterilize,
and reassemble
the fluid path components
between batches.
Changes from
one reagent to an -
other take only a
few minutes and
require no special
tools.
The total startup
time traditionally
would take
about 30 minutes,
but automating
the line reduces
the start-up time to
about 10 minutes,
says Dunn. The
equipment was cus10
Intro
Cov
www.medicaldesignbriefs.com
ToC
+
-
A
Medical
Design Briefs, July 2021
µ
È
http://www.medicaldesignbriefs.com
Medical Design Briefs - July 2021

Table of Contents for the Digital Edition of Medical Design Briefs - July 2021
