Webinar originally ran May 2019.
Download the recording and slides using the link at the bottom of the page.
This presentation will concentrate on strategies used to evaluate extractables and leachable (E&L)
risk and consider origins, definitions, testing and leachable risks evaluations.
To aid manufacturing and delivering new drugs to patients, disposable systems have seen significant increase in use and new technologies becoming available. Early adopters and users of single use technologies (SUT)
are biopharmaceuticals and cell therapeutics; however it has been reported that E&L concerns are a significant barrier to SUT adoption.
The United States Pharmacopeia (USP) has published draft chapters (<665> and <1665>) on this subject, the latest draft having been released 1st Mar 2019 (PF 45 (2)). In addition the Parenteral Drug Association (PDA), Bio Process Systems Alliance (BPSA) and Biophorum Operations Group (BPOG) have both published recommendations for assessing E&L.
This presentation will centre around strategies used to evaluate E&L risk and consider:
- Leachable risks evaluations.
The presentation is the first in a series of webinars covering Single Use Technology. Future topics include: Physical and Functional Testing; plus Packaging, Distribution and Transit Testing.
Michael Creese manages Smithers' Extractables and Leachables (E&L) and Chemical Analysis consultancy team in the UK. He has been working with E&L for over 15 years both for Biopharmaceuticals and Pharmaceuticals, and joined Smithers in 2009. Michael has used his expertise to solve the challenges of the assessment of E&Ls for Single Use System suppliers and users (bags, tubing, filters, connectors etc.) and Final Container Closure Systems (pMDIs, stoppers, vials, pre-filled syringes, cartridges etc.).
Find out more about our extractables and leachables testing
facilities at Smithers.
Download the webinar below: