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What Do Pharmaceutical & Medical Device Manufacturers Need to Know About Extractables & Leachables Testing?

What are Extractable and Leachables?

Leachables are trace amounts of chemicals originating from packaging, containers, medical devices or process equipment that end up as contaminants in medicinal products or food resulting in exposure to patients or consumers.

Extractables are substances that can be released from a medical device, pharmaceutical packaging or food contact surface using extraction solvents and/or extraction conditions that are expected to be at least as aggressive as the conditions of use.

Leachables are associated with the actual use conditions while extractables are those things observed under simulated conditions which are generally an exaggerated form of the use condition.

Why Do They Need to be Tested for?

Leachables and extractables can have an adverse effect on product safety or efficacy. A number of high profile cases including a 2009 Tylenol Arthritis Pain caplets recall can be traced to leachables.

How Do You Test for Them?

Testing for E&L's is performed by first extracting the samples under controlled conditions designed to replicate the product use and under suitable exaggerated conditions. These extracts are then analyzed by mass spectroscopy and chromatography methods to identify individual extractables and leachables. The amount of each compound is then determined and finally a toxicological review is performed to assess safety.

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Which are the Recommended Methods?

E&L analysis is typically performed using a combination of liquid chromatography mass spectroscopy (LCMS), gas chromatography mass spectroscopy (GMCS), inductively coupled plasma mass spectroscopy (ICP-MS) and headspace gas chromatography mass spectroscopy (HGCMS). Together these techniques cover the full range of volatile, non-volatile, organic and inorganic extractables and leachables.

What Do the Results Tell You?

The results provide a list of what chemicals extract and in what quantity, enabling a toxicological review of the safety of the product.

Why are These Results Useful for those in the Pharma and Medical Device Manufacturing Sector?

They help the manufacturer and consumer of these products verify product safety and efficacy.

What Does Jordi Labs Offer that can help with this?

Jordi provides a complete E&L solution and can perform even the most complicated E&L projects. Jordi Labs uses only the most state of the art QTOF-LCMS and QTOF-GCMS systems providing more definitive identifications and more accurate quantitations. This allows for a better safety determination.

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What is Jordi Labs Doing to Create Advancements in this Field?

Jordi Labs has pioneered development of improved methods for identification and quantitation of extractables and leachables as detailed in our publication entitled: Qualitative assessment of extractables from single-use components and the impact of reference standard selection.

This article was published in the Journal of Pharmaceutical and Biomedical Analysis, Volume 150, 20 February 2018, Pages 368-376.

We were also one of the first labs to institute Quadrupole Time of Flight (QTOF) technology for more definitive identifications and are one of the only labs in the country with soft ionization GC-QTOF capability for identification of volatile extractables and leachables.

About Dr Mark Jordi

Dr Mark Jordi

Dr. Mark Jordi is the President of Jordi Labs, a position he has held since 2006. During that time, Jordi labs has experienced 14 years of consecutive growth and has become a leader in the polymer analysis industry. Jordi now provides over 2000 analyses annually and offers more than 60 analytical techniques serving a wide range of industries including the pharmaceutical, medical device and chemical industries. Dr. Jordi completed his B.S. in chemistry at Olivet Nazarene University and his Ph. D. at the University of Connecticut in the materials science division, where his work focused on surface initiated polymerizations from nanoparticle surfaces. His primary interests include development of improved strategies for identification and quantification of Extractables and Leachables as well as chromatographic and mass spectrometric analysis of polymer systems.

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