Numerous components make up a polymer system beyond the underlying polymeric structure: antioxidants, cross-linkers, plasticizers, surfactants, etc. Their diversity is such that it is possible to find hundreds of individual small molecule species within a single polymer system, each with distinct properties and functions. E&L (extractable and leachable) testing is concerned with identifying those molecules that may be extracted from and/or leached out of commercial plastics.
E&L testing is paramount for biomedical devices and food contact materials as it can help identify species within a polymer that may impart toxicity.Determining extractables and leachables in polymeric materialsis, therefore, a matter of both ethical and regulatory necessity. Yet, it is not the most common type of quality assurance and control (QA/QC) methodology and there is limited literature available for newcomers looking to purpose-build an E&L testing study.
In this whitepaper, Jordi Labs offers a comprehensive overview of the E&L testing landscape before outlining the general process in significant depth; from the earliest preparatory steps to final quality control of results. The following topics are discussed:
- Definitions
- The purpose of E&L testing
- Why is E&L testing important?
- The regulatory environment
- What are extractables and leachables?
- How is an E&L study conducted?
- Sample selection
- Sample preparation
- Extraction conditions
- Identification of E&Ls (qualitative analysis
- Determination of E&L concentration (quantitative analysis)
- Acceptable levels for E&Ls
- Quality control in an E&L study
If you have any questions that have not been answered in the whitepaper, please feel free to contact a member of the Jordi team today.
