Extractables & Leachables Testing
Extractables and leachables can pose a serious risk to pharmaceutical and medical device products. If elements and compounds leach into products from packaging, container closures (primary or secondary) or manufacturing environments, they can render them unfit, and even dangerous, for use.
If a container-closure system does release chemicals into drug products, they can accumulate in sufficient levels to cause a toxicity risk and affect product stability and efficacy. We perform extractable and leachable analysis to identify such risks.
Extractables analysis identifies substances which could potentially migrate from polymeric, metallic, rubber or glass container materials into the patient or consumer; examples include dyes, catalysts and plasticizers. Depending on the product type, the extractions follow ISO 10993 or USP <1663> and typically cover a range of solvent polarities or similar extraction media. We use a range of techniques including LC-MS, GC-MS and ICP-MS analysis.
Leachables analysis identifies substances which migrate from polymeric, metallic, rubber, or glass material into the final product. The container may be a combination of materials and could also have a coating that needs to be taken into consideration. Any labelling and/or adhesives may also be a contributing factor. Leachables can negatively affect the product and even harm the end user. They are typically a subset of those substances identified in the extractables analysis.
Forced or accelerated analysis of leachable compounds can be performed under environmental simulation conditions, to study the expected behaviour of a product in application and under storage conditions.
Long term stability analysis can be performed to study the effects of the product under normal product conditions. This is especially useful for identifying secondary leachables – compounds that can form over time when a primary leachable reacts with the drug product - and can sometimes only be identified through long stability studies. Due to the complexity of many drug products, the study is important to ensure the various product components, their packaging and environments, don’t have unforeseen and adverse interactions in the long term.
Manufacturers are expected to perform Extractables and Leachables (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 which can be extremely complex due to the different types of materials and environments involved. It is important therefore that your E&L studies are designed specifically for your product, processing facilities and storage units. This profile then makes it quicker and easier to identify leachables and assess toxicological risk.
More than just Extractables and Leachables Testing
Our labs provide characterization investigation of extractables and profiling for organic and inorganic materials. Understanding the profile of these materials is important for subsequent actions and data rationalization.
Our official partnership with Bibra, the toxicology advice and consultancy experts, means we can offer a one-stop-shop for extractables and leachables studies and toxicology investigations. This allows us to identify and resolve any gaps in your existing data and assess potential risks.
Our laboratories are cGMP compliant and ISO 17025 accredited. We perform testing to ISO and pharmacopeial standards.
On Demand Webinars
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.