Extractables and Leachables (E&Ls) are the tiny molecules present in a polymer system including surfactants, antioxidants, slip agents, residual monomers, acid scavengers, plasticizers, crosslinking agents, lubricants and oligomers. It is not unusual to find tens or even hundreds of separate small molecules species which are extractable from a specific polymer system based on the extraction conditions.
Performing an Extractables & Leachables (E&L) study is a crucial part of confirming the safety of a medical device product. Design of an E&L study requires an awareness of the materials used to build the device and the probable use conditions. The laboratory which conducts the study must have adequate expertise in unknown identification to correctly leverage information from multiple databases, methods, and control experiments to allow for positive unknown identification.
They must also have the breadth of instrumentation which allows for investigation of a broad range of probable analytes. Lastly, they must also be experts at analytical technique development such that they can utilize this knowledge to create quantitative techniques for the components identified.
The reliability and accuracy of an E&L study should be established using stringent quality control measures. This includes some or all of the topics listed below based upon the quality system requirements for a separate E&L study:
- Analysis blanks
- Positive controls or spiking studies
- Negative controls
- Validation of analytical techniques
Jordi Labs focuses in the examination of plastics and has the experience and knowledge to make customer’s E&L study a success. Jordi partners with customers to develop and implement E&L studies empowered by over thirty years of analytical experience and advanced instrumentation.