Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Clinical Trial Supply Europe 2019

13-14 March 2019, Milan, Italy

Following on from our largest and most engaging meeting to date, Clinical Trial Supply Europe will be returning to Milan for its 20th year in 2019! The 19th annual edition welcomed pharmaceutical companies across Europe who got together to share knowledge and issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates discussed issues which affected their business in our dedicated operational and technological streams.
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