E&L testing refers to the examination of the type and amount of small molecule substances which come out of a polymer system, with an emphasis on characterizing the impact of extractable and leachable chemicals on consumers. It is a critical method for determining the safety profile of materials used for medical devices, pharmaceutical packaging systems, food contact materials, and other products, by assessing their potential for transferring small polymer molecule species into the human body. This molecular transference can expose patients to trace amounts of potentially hazardous chemicals.
Extractables are defined as compounds that can be extracted from a polymer product using a solvent which is stronger than the intended use conditions, while leachables are characterized as compounds that leach into a drug product (under the expected use condition) through contact with manufacturing components or packaging media. Leachables are expected to be a subset of extractables for a well-designed study.
This article will explore the practice and purposes of E&L testing in further detail:
What is E&L Testing?
Chemical migration from medical devices or pharmaceutical packaging systems can be accurately determined through robust E&L testing. This holistic process begins with analysts acquiring a thorough understanding of a product’s composition and its usage conditions, before designing a strategy for sample preparation and extraction. Characterization of these extracts allows for an assessment of the E&L’s for the device or packaging product, and subsequent toxicological evaluation of those species.
Typical examples of E&L’s include extractable molecules such as:
- Antioxidants
- Chemical scavengers
- Cross-linkers
- Lubricants
- Oligomers
- Plasticizers
- Surfactants
- Slip agents
- Residual monomers and oligomers.
E&L Testing Applications
The pharmaceutical and food sectors regularly employ E&L testing to assess the toxic potential of small molecule species in packaging systems, which can contain tens of different species. Packaging media includes primary and secondary plastic containers, sealing adhesives, and packaging inks. In pharmaceuticals, these substances might not exhibit harmful effects on their own, but could alter the biologics of the drug and detrimentally affect the dosage efficiency of active ingredients.
E&L studies are also applied to medical devices which can contain a variety of polymers including polyurethanes, polycarbonate, silicones, polyethylene, polyvinylchloride (PVC) and more. These devices also contain additives, fillers, byproducts and impurities which are an important part of the E&L study.
Beyond the medical industry, E&L testing is used to determine the presence of small compounds in commercial products that introduce elements into the body. Electronic nicotine delivery devices, for example, must be studied to determine the presence of potentially harmful polymer species in the plastic housing, the vapor inlet, or the composition of inhalants.
E&L Testing with Jordi Labs
Jordi Labs was established in 1980 to provide excellent and innovative analytical services with uncompromising integrity. We now offer numerous analyses for polymer technologies, pharmaceuticals, medical devices and the biotechnology sectors.
Our expertise in E&L testing encompasses background information gathering, tailored study design, method development/validation, and unknown extractables and leachables identification. Jordi Labs has continuously demonstrated expertise in the field of E&L testing for various polymeric materials used in medical devices, container closure systems, single use systems, packaging and more.
If you would like any more information about performing E&L testing the Jordi way, please do not hesitate to contact us.