samedan logo

 
 
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

SGS Enrolls First Patient into Biophytis’ COVA Clinical Study, a COVID-19 Clinical Trial

SGS was chosen by French biotech company Biophytis to conduct its COVA study – a Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure.
More info >>


White Papers

Stripping the confusion out of PVC curtains... and a new seat range.

Teknomek Ltd

With the ever-growing trend towards modularisation of clean rooms and laboratories; Teknomek have responded with a new range of PVC strip curtains, suitable for use in environments where maintaining clean airflow is critical. This new PVC curtain range includes specialist perforated and electrostatic discharge alternatives to the standard options of clear and polar (-25oC) versions.
More info >>


Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement