spacer
home > white papers > Extractables and Leachables Testing: A Risk Based Approach - RSSL
WHITE PAPERS
logo_RSSL.jpg

RSSL

phone +44 (0)118 918 4024
web http://www.rssl.com
email University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA

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.
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

PCI Clinical Services Announces Launch of a Mobile App for its Comprehensive Customer Support Portal Webflow™

Philadelphia, USA – 15 November 2017. PCI has today announced the launch of a mobile application (app) to provide more convenient access to its client services online portal Webflow™. Webflow™ is a comprehensive customer support center which provides PCI clients real-time, 24/7 access to a wide range of reports and information regarding the status of their Clinical Trial supplies across all PCI Clinical Services sites in Europe and North America. The new free app, available on Android and Apple iOS, is designed to provide even more flexible access to the Webflow™ offering – enabling customers efficient and effective on demand supply chain management to meet the ever-changing requirements of global trials.  
More info >>


White Papers

Clinical Research in Spain

BioClever

This whitepaper is on clinical research in Spain, giving a general outline of the main characteristics of research in this country and an overview of the applicable regulations, along with the reasons why Spain is a good place to do research.
More info >>


Industry Events

Clinical Trial Supply Forum 2018

22-24 January 2018, London, UK

In the constantly changing environment of Clinical Trial Supply, cost efficiency, end to end visibility, logistics and managing complex pipelines are STILL crucial elements that need addressing!
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement