An extractables and leachables study (E&L) is one of the most important safety precautions when developing a new drug. Any impurities related to container and closure in drug products will be identified and reported during this study. They’re not only important for safety, but required by the FDA before product approval.
But why are E&L studies so important? What products need E&L testing? How can Avomeen help? Our Senior Technical Director of Biopharmaceutical Sciences, Neelam Varshney, is here to answer the top five most frequently asked questions about E&L studies.
What is the Difference Between an Extractable and a Leachable?
Extractables are organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction and into an extraction solvent under laboratory conditions. Extractables can be potential leachables as well.
Leachables are foreign organic and inorganic chemical entities that are present in a packaged drug product. They have leached into the packaged drug product from a packaging or delivery system, packaging component, or packaging material of construction under normal storage conditions and use or during accelerated drug product stability studies.
When Should an E&L Study Be Performed?
E&L Studies are used to test product packaging to ensure the packaging will not leach harmful chemicals into the product during usage. These studies are extremely important for many industries, but specifically in the pharmaceutical and medical device industry especially as packaging safety and toxicology studies are required for product registration. Every new and generic drug product must be assessed for extractables and leachables to evaluate the safety concern threshold of possible entities before approval to enter the marketplace.
What Types of Products Does Avomeen Have E&L Experience With?
Products we have previously worked on include but are not limited to:
- Plastics & polymers
- Rubbers & latex
- Single-use syringes
- Bottles and caps
- Laminated tubes, inserts & caps
- Blister packaging
- Wearable pumps
- Device components
- Single-use systems
What Types of E&L Studies Does Avomeen Support?
Avomeen’s expert, advanced degree chemists specialize in:
- Extractables/Leachables evaluations
- Extractables screening
- Ensuring the compatibility of drug and container/closure
- Method development & validation for leachable studies
- Developing routine leachable control methods
- Ensuring safety relative to packaging adulterants that may enter the supply chain
Our scientists have extensive experience working on FDA approvals and can work with you to develop a customized testing protocol.
What Guidelines Does Avomeen Use For E&L Studies?
Protocols and methods are not one-size-fits all. Our skilled chemists are flexible with protocols and methods. By doing this, we save you both time and money. Avomeen’s laboratories are FDA-registered and cGMP-compliant. We also keep up to date on the United States Pharmacopeia (USP), International Harmonization Committee Guidances, International Organization of Standardization (ISO), and European Pharmacopeia (Ph.Eur.) guidelines. Study Protocols are designed after discussions of product and packaging with clients and based on some of these guidances:
- USP <661.1> Plastic Materials of Construction
- USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
- USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
- M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk
Avomeen’s Extractables and Leachables Testing Studies
Avomeen is equipped to handle any kind of extractable and leachable study regardless of industry. Let our scientists guide you through the process while meeting FDA regulations. If you’re ready to get started, connect with an expert here.
Working on an ANDA for the FDA? Avomeen can help. Read up on our Extractables/Leachables Case Study: Controlled Drug Solution in a PET Bottle.
Get more information about our proprietary polymer additive library in our blog, Best-In-Class Polymer Additive Library for Identification of Extractables.
Learn more about the Long & Short of USP Guidelines for E&L Testing in our blog.
Get more information on what not to do in our blog, Common Pitfalls in Extractables & Leachables Testing.
Explore The Growing Need for E&L Testing of Biopharmaceutical Manufacturing Equipment with Dr. Andrew Kolbert.
Our expert blogger is Neelam Varshney, Avomeen’s Senior Technical Director of Biopharmaceutical Sciences. She has extensive experience in all CMC aspects of pharmaceutical products, and her expertise ranges from preclinical to post approval regulatory requirements.
Learn more about Neelam’s expertise and experience.