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Potential Designs for Leachable Studies on Biopharmaceutical Manufacturing Equipment
Автор: Nelson Labs
Загружено: 2024-10-21
Просмотров: 172
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Leachables studies on equipment used in (bio)pharmaceutical production processes are somewhat less common and standardized than in the context of pharmaceutical containers. This presentation will elaborate on multiple case studies, in which a variety of study designs will be discussed. The presentation will focus on the practical aspects and pinpoint the diversity of practical study designs (and related challenges), which contrasts with the rather well known and rather standardized nature of leachables studies on container closure systems.
Pieter Van Wouwe – Senior E&L expert – Nelson Labs
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