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 EL risk from single-use components can be used to build the level of extractable profiling and PERLs

Bibliographische Detailangaben

Veröffentlicht in:	Biopharm international 2024-06, Vol.37 (6), p.27
1. Verfasser:	Ramesh Raju Mavuleti, K. Vasantakumar Pai, K. Sreedhara Ranganath Pai, Subhasis Banerjee, Somasundaram Gopalakrishnan, and Tathagata Ray
Format:	Magazinearticle
Sprache:	eng
Schlagworte:	Health risk assessment Materials Methods Pharmaceutical industry
Online-Zugang:	Volltext
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