The article provides a detailed overview of the E&L testing process used to determine extractables and leachables from plastics. This process is mostly preferred for plastics employed in food contact applications and in biomedical devices.
The following topics are described:
- The purpose of E&L testing
- Why is E&L testing important
- Regulatory Environment
- What are extractables and leachables?
- How is a 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