E&L: Key Principles of Extractables & Leachables Analysis

E&L testing is a critical process in pharmaceutical packaging development and medical device manufacturing. Unlike many other forms of laboratory analyses, it cannot be broken down into a series of simple methods. This is primarily due to the complex and infinitely variable forms of extractable and leachable elements, compounded by the fact that extractable compounds can originate from various points in the production cycle.

Custom E&L Studies: 7 Steps to Success

One of the most fundamental principles of E&L testing is that all studies should be carried out on a completely holistic basis. It is vital that polymer systems of interest are subjected to robust analysis using the leading techniques.  Detecting and identifying extractable and leachable components are merely an aspect of the overarching process. In order to accurately characterize extracting constituents and their toxicological significance, it is critical that various analytical techniques are implemented.

At RQM+ Lab Services, we have a wealth of experience designing custom E&L studies for biopharmaceutical manufacturers of all scales. This gives our team the confidence to not only detect extractable and leachable constituents in your products but to determine their toxicological relevance.

Acquiring Background Information

As with any analytical service, the first step revolves around our team gathering background information about the composition of your device/ packaging. We will also look to build a full profile of the patient exposure, typical storage, and clinically-relevant use conditions.

Building the E&L Study

After we have acquired all the relevant background information, we can start designing your custom study. This is the point at which we will determine the best analysis techniques and select samples for subsequent extraction. We can also design the extraction conditions at this stage, and plan accordingly. When suitability of solvents is not known, a feasibility study can also be performed to confirm extraction conditions. A protocol would be prepared outlining extraction conditions. Once the design strategy is determined, a protocol is prepared outlining the extraction conditions and analytical testing. The protocol is then sent for approval by your team prior to implementation.

Sample & Control Preparation

Once you are content with our design proposal, we can begin to prepare samples for extraction and run the relevant controls. These may include running the full E&L testing chain with analysis blanks or a negative control group. There are various possibilities at this stage as there is no universal process for extractable and leachable analysis.

Extraction, Identification & Quantification

These are three separate steps in the overall E&L testing chain, but they can often be carried out in tandem with increasingly integrated instrumentation enabling chemists to characterize a full list of extractable and leachable compounds in samples. This fundamentally depends on the analytical techniques and extraction parameters set out at the start of the study.

Toxicology Evaluations

Finally, we always aim to put the presence of E&L contaminants into context by running full toxicological risk assessments to determine the toxicological relevance would be if the observed extractables and leachables made it through to the end-user/consumer.

Looking for E&L Testing Services? RQM+ Lab Services is a tried-and-trusted analytical services laboratory with unmatched experience providing E&L testing and toxicology analysis. With a commitment to custom testing and a wealth of experience in the regulatory space, we are the industry leaders in E&L analysis. If you would like to discuss our services, simply contact a member of the RQM+ Lab Services team today.