20 BioPharm International eBook June 2019 www.biopharminternational.com
Single-Use Systems Extractables and Leachables
Extractables and Leachables:
Determining Risk in Single-Use Systems
As SUS become prevalent in the biologics industry, the question
of safety becomes increasingly important.
S
ingle-use systems (SUS) are increasingly
becoming the norm in biologics development
and manufacturing. Approximately 85% of
the pre-commercial biopharmaceutical sec-
tor use SUS, and they are increasingly being
adopted for commercial manufacturing. SUS have
significant advantages but are not without drawbacks.
A 2018 survey showed that 73.3% of biologics insiders
listed contamination from extractables and leachables
to be a major problem (1).
SINGLE-USE SYSTEMS
While a limited number of SUS products were tra-
ditionally used in biologics manufacturing, such as
filter membranes and silicone tubing, a major shift
took place in the 2000s with the introduction of new
SUS products. Today, SUS are used for a variety of pur-
poses, including filters, process containers (bags),
tubing, connectors, gaskets, valves, and packaging
(finished products).
Growth in the SUS sector has been rapid, a trend
that is predicted to continue. In 2013, SUS in the phar-
maceutical industry was worth approximately $1.4
billion, by 2018 it had reached $3.5 billion, and it is
estimated the sector will reach $11 billion by 2023 (1).
fotoblin
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ANDREAS NIXDORF is Business Development Manager Extractables &
Leachables Testing at SGS.
ANDREAS NIXDORF