Unless you’re a toxicologist, you’ve probably never heard the terms. But if you’ve ever had to take medicine, whether that be from a vial, a jar or even a needle, this issue has been studied, and assessed, and perhaps even prevented.

Modern drug ampoules

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Extractables and leachables (E & L) are the chemicals that can potentially leak into pharmaceuticals during the manufacturing, storage and delivery process. Medicine is created in processing equipment such as test tubes and reaction vessels, packaged in things such as glass vials and plastic bags, and delivered in a whole range of devices such as catheters or needles. All these materials have the potential to leach very small amounts of other chemicals into the medicine, thus altering the drug. This could have serious consequences for the safety, strength and quality of the drug.

These contamination issues are also present for other consumables, food and cosmetics. It is therefore essential to ensure that this does not occur, as the purer the drug, the more effective it is.

So What Are Extractables and Leachables?

Extractables are compounds that can be extracted from rubber and plastic components, coatings of, and residues on the materials when in the presence of appropriate solvents and under stressed extraction conditions.

Leachables are chemicals that transfer into the medicine from rubber, plastic, or coating of the materials.

Leachables also include contaminants from processing aids such as lubricants, cleaning and washing agents used during the manufacture of the drug product.

Identifying Sources

Part of the job for those involved in the field of extractables and leachables is identifying the sources that anomalous chemicals may come from. Some products that may be of concern at the moment are inhalation drug products, nasal drug products, ophthalmic drug products and oral non-solid drug products.

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Fortunately for us, the general public, there are companies out there who study extractables and leachables, assess the risk and establish quality control. Using a range of methods and analytical techniques, the risk assessor carries out studies on all of the materials that the drug or product comes into contact with to establish what chemicals may leach under what circumstances and whether they present any potential hazard. They then tell the manufacture if they need to change any of their processes or materials, ensuring that their product is safe to use.

Experts in their Field

The scientific community involved in this field are constantly working to improve their strategies for discovering new sources, extraction methods, knowledge of compounds and materials, quality standards and regulation. There are several conferences, seminars and webinars that occur throughout the year and all over the world, meaning that the practitioners are constantly sharing information and ideas to ensure the safest drugs, food, cosmetics, and consumables.