Extractables & Leachables Resources

We release content resources regularly, aimed to support the understanding of E&L requirements across various industries – including ENDS & eLiquids, medical devices, and pharma.

Find a selection of our eBooks, white papers, and on-demand Q&As, each created by our in-house E&L experts. We hope that you will understand the process, it’s importance in product safety, and what’s required of you to comply with regulations.


PAST EVENTS


The ever-changing world of E&L virtual conference. On-Demand.

Extractables and leachables are important considerations in the production of medical devices and medicinal products. While COVID-19 is around, new ventilators and delivery devices for vaccines require urgent testing. This conference, now available on-demand, offers insight into this ever-changing world of E&L.


Watch on-demand

The ever-changing world of E&L virtual conference Part 2. On-Demand.

Following the success of our first Global E&L event, we set up a second part.

Extractables and leachables are important considerations in the production of medical devices and medicinal products. While COVID-19 is around, new ventilators and delivery devices for vaccines require urgent testing. This conference offers insight into this ever-changing world of E&L.


Watch on-demand

E&L in ENDS & eLiquids Q&A. On-Demand.

On-demand one hour Q&A session focused on extractables and leachables analysis of nicotine delivery systems and e-liquids.

Answering questions and discussing topics such as:

  • Extractable and Leachable study design
  • Analytical techniques
  • Toxicological assessment of E&Ls
  • Standardised approaches to extractables and leachables

Watch on-demand

Live Q&A – E&L Assessment of Cell and Gene Therapy. On-Demand.

In case you missed it here is a recording of our live Q&A session focused on extractables and leachables assessment of cell and gene therapies (C&GTs).

To get the conversation started, we also recently released a series of 3 blogs. First, we described how and why E&L in cell and gene therapies are important, followed by another comparing C&GT with mAb and a 3rd blog looking at simulation studies. So make sure to catch up on those.


Watch on-demand

EBOOKS & WHITE PAPERS


White Paper – Demystifying Extractables Testing

This white paper was written in collaboration with Parker to aid pharmaceutical companies interested in employing single-use systems in their drug manufacturing, storage, and delivery processes. It highlights the importance of extractables and leachables testing.


Download the white paper

E&L Extraction Techniques – Volume 1

There is no single extraction technique that can provide all the information needed for an extraction study. As a result, multiple techniques are typically used.

This eBook, volume one in a series, details the key liquid extraction techniques, explaining how the equipment is set up and used, as well as the advantages, disadvantages, and limitations of each.


Download the eBook

E&L – Assessment of Material Changes eBook

During the lifecycle of a drug product, there are likely to be a number of changes to the materials or components used to manufacture and store it. This is especially true when the manufacturing processes involve single-use components.

This white paper considers the key factors when undertaking material changes, including;

  • Types of material changes and when they occur
  • Definition of risk as it relates to extractable and leachable compounds
  • Types of studies which assess materials and help us understand risk

Download the eBook

Guide to Extractables & Leachables for ENDS – White Paper

This white paper answers the questions many ENDS manufacturers are asking. It covers:

  • Background to extractables and leachables (E&L) analysis
  • What are E&Ls?
  • What do e-cigarette regulations say about E&L?
  • What e-cig/vape components require E&L scrutiny?
  • What are some of the specific E&Ls we should be aware of?
  • What should you do to stay ahead of regulation?

Download the White Paper