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RSSL

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Extractables and Leachables Testing: A Risk Based Approach

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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News and Press Releases

Saudia Cargo kicks off twice a week Passenger as freighter flight to Copenhagen

May 2021 JEDDAH, KSA – Saudia Cargo kicked off, on Saturday 22 May 2021, its twice a week Passenger as freighter flights to Denmark’s capital Copenhagen, widening its route network in Scandinavia for pharmaceuticals and perishables. Saudia Airlines B777-300 passenger planes with 140-ton payload capacity per flight are being utilized as “preighters” on the route scheduled for Wednesday and Saturday.
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White Papers

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.
More info >>


Industry Events

Pharma Integrates 2021

16 November 2021, VIRTUAL CONFERENCE

Now in its tenth year, Pharma Integrates is a unique event bringing together pharma and healthcare leaders across the Pharmaceutical pipeline to address their needs, to share insights and create debate on crucial topics that influence the future of patient outcomes.
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