Single-use plastic systems are being utilized more frequently, especially for COVID-19 vaccine manufacturing. However, issues regarding the standardization of quality information limit implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, we discuss approaches to decision-making based on the extractables data package. In addition, we highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
Simone Biel, Ph.D.
Senior Regulatory Consultant
Simone Biel provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on single-use technology. Over the years, Simone has supported biopharmaceutical drug manufacturers’ implementation of single-use technology in their manufacturing process. With her deep understanding of single-use technology market needs and industry trends, she is the subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in microbiology.
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