Introduction to Extractables and leachables:
Definition of extractables and leachables
Why are they important
Regulatory standpoints and requirements
Working groups and guidance documents
Determination of limits
Discussion of polymeric and elastomeric materials
Polymer additives, potential impurities and the reasons for their presence.
Review of supply chain
Factors affecting the migration of compounds
11:00 - 11:30 Morning networking break
Component review & selection of critical parts
Aim of extractable study
Extraction methods, including solvent choice and sample preparation techniques.
13:00 - 14:00 Light lunch
What techniques are required
Starting points for methods
15:30 - 16:00 Afternoon networking break
Leachable Method Development & Validation:
Leachable method development
Selection of extractable / leachable compounds
Development of leachable analytical methods
Leachable method validation
Stability storage overview
Leachable time point analysis
17:30 Workshop ends
Tickets are just £799 in addition to your 2-day conference ticket. Places are limited so we advise booking as soon as possible to avoid missing out!
Please note, you must book (or have already booked) an Extractables & Leachables Europe 2019 conference ticket in order to attend the workshop.