Extractables & Leachables Testing
Extractables and leachables can pose a serious threat to pharmaceutical manufacturers. When elements and compounds leach into products, from packaging or manufacturing environments, they can render them unfit and even dangerous for use. We test not only for what does leach but also for all potential extractables in your process and packaging.
Extractables analysis identifies substances which could potentially migrate from polymeric, metallic or glass material into the patient or consumer; examples include dyes, catalysts and plasticizers. The extractions follow ISO 10993 or USP <1663> and typically cover a range of solvent polarities or similar extraction media. Our experts include a range of techniques including LC-MS, GC-MS and ICP-MS analysis.
Leachables analysis identifies substances which migrate from polymeric, metallic or glass material into the patient and are typically a subset of those identified in the extractables analysis. This type of analysis is required when there is a risk that harmful substances may have leached into a liquid product, such as eye drops, from its container or packaging. We perform testing to ISO standards or USP <1664>.
Manufacturers are expected to perform E&L testing on materials used in production systems, delivery systems, and container closure systems. Failure to provide this information could lead to rejection of regulatory submissions. A profile is developed of all potential extractable compounds. This can be extremely complex due to the different types of materials and environments involved. It is important therefore that your extractables and leachables studies are designed specifically for your product, processing facilities and storage units. This profile then makes it quicker and easier to identify leachables and the toxicological risk can be assessed.
Our extractables and leachables testing also covers analysis of e-cigarettes and drug delivery systems such as syringes.
Medical devices and pharmaceutical products can present a risk to patients by way of exposure to substances present in manufacturing or packaging materials. This webinar, presented by Craig Donald and Malcolm Rose, discusses how to understand and evaluate those risks by following the procedures set out in ISO 10993.
This webinar, presented by George Jones, discusses the new USP <232> Heavy Metals limit test, which will be fully in place by 1 January 2018, and the effects it will have for businesses.