A model of prefilled syringes exposure to vapor phase hydrogen peroxide (VPHP)

Vaporized hydrogen peroxide sterilization in the production of protein therapeutics: Uptake and effects on product quality

M Meleties, BM Cooper, D Marcano-James… - Journal of …, 2023 - Elsevier
The aseptic filling of drug products is carried out in pharmaceutical isolators that have been
sterilized. A commonly used method for achieving a high level of sterility assurance is …
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Stress factors in protein drug product manufacturing and their impact on product quality

TK Das, A Sreedhara, JD Colandene, DK Chou… - Journal of …, 2022 - Elsevier
Injectable protein-based medicinal products (drug products, or DPs) must be produced by
using sterile manufacturing processes to ensure product safety. In DP manufacturing the …
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