E&L testing (Extractables and Leachables)在塑料产品上进行，以确定从聚合物系统中释放的小分子，包括抗氧化剂，表面活性剂，滑移剂，增塑剂，酸清除剂，交联剂，润滑剂，残留单体和寡聚物。根据提取条件，发现可从给定的聚合物系统中提取的数十个甚至数百个单独的小分子物种并不少见。
表演提取物和浸润物(E&L) testingis an important part of verifying the safety of a medical device product. Design of an E&L testing study requires an understanding of the materials used to construct the device and the expected use conditions. The laboratory which conducts the study must have sufficient expertise inunknown identificationto properly leverage information from multiple techniques, databases and control experiments to allow for positive unknown identification. They must also have the breadth of instrumentation which allows for analysis of a wide range of potential analytes. Finally, they must also be experts at analytical method development such that they can utilize this knowledge to develop quantitative methods for the components identified.
The accuracy and reliability of an E&L testing study should be confirmed using rigorous quality control measures. This includes some or all of the topics listed below depending upon the quality system requirements for an individual E&L study:
- Analysis blanks
- Negative controls
- Positive controls or spiking studies
- Validation of analytical methods
Read more about the process used to确定塑料的萃取物和浸润物（E＆L）测试in the white paper.
Jordi Labs specializes in the analysis of plastics and has the experience and knowledge to make your E&L study a success. Jordi partners with our customers to develop and execute E&L studies empowered by more than 3 decades of analytical experience and state of the art instrumentation.
浏览我们的萃取物和填充物（E＆L）测试研究
Our team of PhD chemists is researching this rapidly changing area of analytical chemistry. We will publish our white papers and case studies here.
E＆L测试in Polymeric Materials White Paper
Read our overview on our process of E&L testing for plastics.
Nylon Syringe Filter E&L Testing Case Study
研究尼龙注射器过滤器的可萃取和浸润物（E＆L测试）。
Polymer Deformulation of a Medical Device
The objective of this work was to investigate the chemistry of a polymeric urinary drainage bag. The goal was to deformulate the device.
Sterilization of Surgical Instruments
在典型的清洁/高压灭菌过程之后，医疗设备上可能剩余的化合物的化学反应是什么？
