Biomedical Engineering Reference
In-Depth Information
What are the factors to
consider when
implementing a single-use
technology?
Is my application mixing and buffer preparation? Is my
application fermentation or other bioreactor cell growth
process? Will I require significant filtration and refinement?
Will I be making the final drug product? What
environmental control and handling procedures do I have
in place and how to they differ with single-use? How much
capital
do I have available to invest in initial start-up and/or
technology conversion costs? What
data
is available from
the suppliers to help answer the questions I will get from
the FDA when validating my product and process? Do the
suppliers have a Drug Master File (DMF)? Have the
suppliers performed extensive testing on extractables/
leachables, United States Pharmacopoeia (USP) Class VI,
etc.? How can I reduce the amount of
risk
associated with
my product/process? Am I the first to market with this
process/product? Do others have a roadmap or platform
that can be followed instead of reinventing the wheel?
What data do I have or is available that can help reduce the
amount of risk? Have I implemented QbD to eliminate
future problems and issues? There are many case studies
available on how companies have addressed the four topics
mentioned earlier. Refer to other specific FAQ questions
links or BPSA's landing page:
www.bpsalliance.org
. For
specific inquiries and a referral to an industry expert or
liaison, contact
ottk@socma.com
.
What effect can single-use
technology have on capital
and start-up costs associated
with designing and
commissioning a new
manufacturing facility?
SUSs typically have lower capital and start-up costs. The
capital equipment associated with supporting a single-use
unit operation is far less expensive than for multiuse
stainless systems. One example is that the materials used
to build support systems for single-use operations need
not be electropolished and passivated, similar to the
product contact surfaces of a multiuse system.
Commissioning a SUS is often
faster and simpler
than a
multiuse system. The product contact surfaces or SUSs can
be qualified well in advance of the actual installation,
compressing start-up commissioning time lines.
How does single-use
technology affect ongoing
manufacturing efficiencies
and production costs?
Manufacturing efficiencies and production costs will vary
by company, by manufacturing site, and by unit operation.
In general, overall resource deployment is less with
single-use operations when compared with stainless
operations. A BPSA member company expert can help you
evaluate the economics and efficiencies. To be put in touch
with a company expert, please contact
ottk@socma.com
.
