Millipore Corporation has organised a web seminar entitled 'Risk-based Assessment of Extractables and Leachables from Single-use Systems'.
Presenter Vikas Gupta, group product manager of Mobius single-use products and services, will evaluate various risk-based approaches, including techniques that may make the identification of extractables and leachables in the biomanufacturing process unnecessary.
The event will be held on 8 December 2009 at 13:00 and will be repeated on 9 December 2009 at 09:00.
Gupta said: 'Risk assessment is a critical component of an extractables and leachables evaluation and each project is unique.
'Yet there is limited regulatory guidance that directly addresses extractables and leachables from single-use systems used in the bioprocessing industry.
'This webinar will help attendees understand the pros and cons of the various options available to them,' he added.
During the presentation, Gupta will review regulatory guidelines that can be used to conduct a risk-based assessment of extractables and leachables evaluations.
He will also present case studies that highlight the pragmatic use of the risk-based assessment of extractables and leachables in single-use systems.
'Adopting single-use technologies in product-contact applications, such as ultrafiltration/diafiltration, bulk drug substance storage and final fill and finish, requires a detailed analysis of the risks posed by extractable and leachable particles,' said Gupta.
For information on registering for the webinar programme, visit www.millipore.com/reply/form/mobius-guptawebinar.
