PharmTech.com Trends in Manufacturing eBook May 2024 Pharmaceutical Technology
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Ramesh Raju Mavuleti,
K. Vasantakumar Pai,
K. Sreedhara Ranganath
Pai, Subhasis Banerjee,
Somasundaram
Gopalakrishnan, and
Tathagata Ray
Application of the Risk Evaluation
Matrix as per USP <665> and <1665>
for Evaluation of Leachables Risk
from Single-Use Components Used
in Biomanufacturing
Determining E&L risk from single-use components can
be used to build the level of extractable profiling and PERLs.
BILL
GALLERY-
STOCK.ADOBE.COM
T
he COVID-19 pandemic has given the bio/pharma
industry lessons on being prepared to manufac-
ture parenteral formulations for human use in
emergency situations. Vaccines, remdesivir
injection and amphotericin injection, are such recent
examples. The challenge then becomes having enough
flexibility in the manufacturing lines to facilitate man-
ufacture of large volumes of unit doses of injectables
as may be required with shorter changeover times,
while assuring compliance and patient safety from the
product contact parts used in the manufacturing line.
Single-use manufacturing solutions provide the flexi-
bility in terms of batch sizes, fill volumes, and ease of
manufacturing, especially in terms of manufacturing
different products in the same line with minimum line
changeover requirements. This article reviews and elab-
orates the initial risk assessment process for extractable
and leachables arising from single-use product contact
manufacturing parts as per United States Pharmacopeia
(USP) chapters <665> and <1665>, which go into effect
May 1, 2026 (1,2). The determined risk can then be used
to build the level of extractable profiling and process
equipment-related leachables (PERLs) followed by as-
sessing the patient safety for regulatory submissions.
