Chemical Engineering April 2013 - 24

EMD Millipore
Newsfront
SINGLE-USE
STRATEGIES
Disposable equipment systems satisfy
strategic drivers
for the biotech industry
S
for
ingle-use equipment has come
a long way from its modest origins
as
a convenient
storage
and transportation method. As
a matter of fact, recent market trends
and business drivers have made disposable
equipment, with its inherent
benefits, so attractive to the biotechnology
and
industries
requesting
that
and
biopharmaceutical
they've
begun
implementing
entire systems for use throughout
the process line.
" The initial use of disposables
storage
and
transportation
purposes eventually led to the use
of bags in bioreactors and other inprocess
technologies, which has
more recently led to advances in
downstream use, " says Michael
LaBreck, global product manager
with Novasep (Marcus Hook, Pa.;
www.novasep.com). " As the confidence
has begun to build, we see
companies
biotech
doing
actual
processing in disposables and moving
single-use equipment closer and closer
to the purified product. "
Single-use perks
One of the first benefits that attracted
the biotech industry to single-use
equipment was the reduction of crosscontamination
risk in high-purity applications
where even a few molecules
remaining in the equipment after a
process run could not be tolerated.
In a traditional stainless-steel world,
such a critical application would have
required a strict cleaning regimen
followed by validation. However, the
introduction of disposables allowed
operators to simply throw away the
contaminated components and start
over fresh. " The cost of doing this was
much, much less than dealing with the
possibility of cross contamination and
having to throw away an entire day's
work, " says Wallace Wittkoff, director
of global hygienic segment marketing
with Pump Solutions Group (PSG;
www.psgdover.com), a division of Dover
Corp. (Oakbrook Terrace, Ill.).
While the reduced risk of cross
contamination itself was enough of
a benefit to attract attention, it was
the ability to reduce the labor asso24
CHEMICAL ENGINEERING WWW.CHE.COM APRIL 2013
ciated with cleaning and validation
that made single-use technology especially
attractive. LaBreck says one of
Novasep's customers conducted a Six
Sigma project that compared downstream
processes using traditional
clean-and-reuse methods to the same
processes employing single-use technology.
What they found, he says, was
that the use of disposables eliminated
non-value-added steps like flushing,
cleaning and storage, which reduced
labor and actual process time by 50%.
" Reduced labor time not only provides
a cost savings, but it also increases
productivity for the facility, "
" The initial use of disposables
Novasep
FIGURE 1 (above). The Mobius
FlexReady Solution with Smart Flexware
assemblies for TFF is a fully automated, singleuse
system that is ready to implement and
features scalable fi ltration technologies
FIGURE 2. Sius is a single-use, skid-mounted system for TFF for pre-clinical to clinical
cGMP biomanufacturing applications
http://www.novasep.com http://www.psgdover.com http://WWW.CHE.COM
Chemical Engineering April 2013

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