Ahead of the upcoming Extractables & Leachables China 2021 conference, we caught up with the expert from Sartorius. He gave us a sneak peek of what we can expect from his presentation on day one, taking place during our 'E&L Study on Single Use Systems' session. Learn more about what he shared with us below!
Current Industry Focus:
Q. What are the biggest challenges facing the E&L sector (in China)?
The E&L study should include screening approach to identify and quantify all potential E&Ls. Conducting approach to only analyze limited target substances would miss some risky substances.
Q. What are the biggest priorities for medical device and pharmaceutical companies when it comes to E&L studies?
Medical device and pharmaceutical companies should purchase high-quality SUS from qualified suppliers to decrease the E&L risk and acquire integrated extractables data from SUS suppliers to process initial risk assessment.
Q. What technical issues do you think still need to be addressed in the future?
Regarding the SUS E&L study, appropriate scaling-down components and algorithm converting extractables to actual process should be considered.
Q. How do you think the future regulatory landscape will impact E&L studies in China?
The effectiveness and implementation of USP 665 and ICH Q3E will promote the standardization of E&L study.
Q. Your presentation at E&L China this year is titled “Theory and Practice of Using Extractables Data from SUS for Extrapolation to PERLs ”. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
Theory and Practice of Using Extractables Data from SUS for Extrapolation to PERLs. The single-used system biopharmaceutical industry used is more and more complex, which means it becomes more important to rationally use supplier extractables data to assess risk. I will introduce a software-supported environment such as the Sartorius Extractables Simulator for a reliable data prediction. Combined with the scaling algorithms that based on diffusion-controlled or equilibrium-controlled calculation, I will also provide a prediction of process extractables data.