Extractables and Leachables (E&L) testing is a crucial process in the development and manufacturing of pharmaceutical packaging and medical devices. Contrary to many other methods of laboratory analyses, it cannot be divided into a series of simple techniques. This is mainly due to the endlessly variable complex forms of extractable and leachable elements, combined with the fact that extractable compounds can develop at multiple points in the production cycle.
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Custom E&L Studies: 7 Steps to Success
One of the most basic principles of E&L testing is that all studies should be conducted on a comprehensive basis. It is of key importance that polymer systems of interest are subjected to rigorous analysis while making use of the leading methods. Detection and identification of extractable and leachable components are simple features within the general process. To accurately characterize extracting constituents and the importance of their toxicological features, it is vital to implement several analytical techniques.
Jordi Labs possesses a vast experience relating to the design of custom E&L studies for biopharmaceutical manufacturers of all scales. The team is confidently committed to detecting extractable and leachable constituents in any products as well as determining toxicological relevance.
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Acquiring Background Information
The initial step revolves around the Jordi Labs team acquiring background information about the composition of any devices or packaging primed for analysis. This is so they can build a complete profile of a typical storage environment, patient exposure, and clinically relevant use conditions.
Building the E&L Study
Subsequent to the acquisition of the relevant background information, Jori Labs can commence the design of a custom study. This is the point at which we will determine optimal techniques for analysis while selecting samples for later extraction. It is also possible to design the extraction conditions at this stage and create an appropriate schedule.
When suitability of solvents is an unknown factor, a feasibility study can also be carried out to verify extraction conditions. Therefore, a protocol would be developed detailing extraction conditions. Once the design strategy is identified, a protocol is prepared to sketch out the extraction conditions and analytical testing. The protocol is then sent to the client for approval before implementation.
Sample & Control Preparation
Once the design proposal has been accepted, Jordi Labs can start the preparation of samples for extraction and run the relevant controls. These may include initiating the entire E&L testing chain with a negative control group or analysis blanks. There are multiple potentialities at this stage as there is no universal process in place for extractable and leachable analysis.
Extraction, Identification, & Quantification
While these are three individual steps in the general E&L testing chain, they can frequently be conducted in tandem with integrated instrumentation. This allows chemists to characterize and identify a complete list of extractable and leachable compounds in samples. This relies on the analytical techniques and extraction parameters established early in the study.
Finally, Jordi Labs’ objective is to put the presence of E&L contaminants into context by completing thorough toxicological risk assessments to identify and determine what the toxicological relevance would be if the extractables and leachables observed found their way to the end-user/consumer.
Searching for E&L Testing Services? Jordi Labs is a trusted analytical services laboratory with unparalleled experience in providing E&L testing and toxicology analysis. With a commitment to bespoke testing and vast experience in the regulatory space, Jordi Labs are leaders in the industry where E&L analysis is concerned. To discuss the services on offer, simply contact a member of the Jordi Labs team today.
This information has been sourced, reviewed and adapted from materials provided by Jordi Labs.
For more information on this source, please visit Jordi Labs.