10 BioPharm International eBook June 2019 www.biopharminternational.com
Single-Use Systems Supply Chain
New Strategies for Managing
Single-Use Components
Redundancy should be built into the supply chain.
S
i n g l e - u s e s y s t e m s ( S U S ) a r e g a i n i n g
w idespread adopt ion b ecause t hey ca n
provide a more flexible and cost-effective
approach to biopharmaceutical manufactur-
ing compared to conventional stainless-steel
equipment. As SUS have increasingly been imple-
mented in GMP drug production, supply-chain assur-
ance for SUS materials, components, and assemblies
has become even more important. As with other areas
of the industry, dual-sourcing and redundant manu-
facturing capabilities are crucial in a single-use supply
chain strategy. However, these tenets of supply-chain
management are often misapplied and undervalued,
leading to potential risk that can result in delays or
even stoppages in critical drug production.
SECURING THE SUPPLY-CHAIN
Production of SUS requires a variety of components,
such as thermoset or thermoplastic elastomer tubing,
filters, connectors, and sensors, to build complete
assemblies. The industry has long relied on a dual- or
multiple-sourcing model, in which a drug manufac-
turing company may traditionally provide drawings
for an assembly or component and request bids from
two or more separate vendors to ensure redundancy
for supply chain security. This approach has some sig-
nificant limitations for a variety of reasons.
krunja
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Stock.Adobe.com
TIMOTHY KORWAN, Timothy.Korwan@avantorsciences.com, is a director of
new product development, and JAY HARP, Jay.Harp@avantorsciences.com,
is single-use product manager, both at Avantor.
TIMOTHY KORWAN AND JAY HARP
