Extractables & Leachables Studies Explained
Extractable and leachables (a.k.a. E&L) studies are used to test product packaging to ensure the packaging will not leach harmful chemicals into the product during its storage and use. Avomeen’s expert chemists are trained to identify and quantify both extractables and leachables, validate the analytical methods utilized, and to work with your team to determine the safety implications present and suggest alternative packaging if necessary. E&L Studies are utilized by a variety of industries including pharmaceuticals, medical devices, cosmeceuticals, dangerous goods, foods, and beverages.
Why Is Extractable & Leachable Testing Important?
E&L Studies detect and identify the organic and inorganic compounds that may be inadvertently released into the product. These analytes include low molecular weight oligomers, additives, catalysts mold release agents, dyes and colorants, plasticizers, antioxidants, and stabilizers. Certain extractable and leachable compounds can interact with drug, food, and beverage products, compromising the safety and efficacy of those products.
This type of extractable and leachable testing is critical for the pharmaceutical and medical device industries where packaging safety and toxicology studies are required for product registration. Let our scientists guide you through the process to access and profile your products’ extractables and leachables while meeting FDA regulations.
Trust Avomeen with Your Extractables & Leachables Testing Projects
Tired of having your projects completed under one-size-fits-all protocols? Our skilled chemists understand the science behind extractable & leachable methods and have extensive experience working on FDA approvals. Our staff can modify and customize protocols and methods based on your particular products. By being flexible instead of exclusively sticking to a rigid protocol or method, we save you time and expense.
Avomeen’s laboratories are FDA-registered and cGMP-compliant. We stay abreast of United States Pharmacopeia (USP), International Organization of Standardization (ISO), and European Pharmacopeia (Ph. Eur.) guidelines so that your products can be marketed in the U.S. and around the world.
Become an Extractables & Leachables ExpertLearn More
Avomeen’s E&L Chemists Specialize in:
- Extractable/Leachable evaluations
- Extractable Screening (Intelligent planning for materials selection)
- Ensuring the compatibility of drug & container/closure
- Method Development & Validation for Leachables Studies
- Developing routine Extractable Control methods
- Ensuring safety relative to Packaging Adulterants that may enter the supply chain
Avomeen will work with you to develop a customized testing protocol. Our scientists will address requirements for pharmaceutical packaging or medical device registration, a label migration study, packaging analysis for food contact materials, or consumer product testing to determine the presence of unknown contaminants.
Extractable Testing Studies
An extractable study identifies organic and inorganic chemical entities that may be extracted from packaging material under certain conditions, such as high heat or pressure. Avomeen’s extractable testing process may include:
- FDA Extraction Testing / Controlled Extraction
- Extraction Utilizing PQRI & USP Protocols
- Analyze Extracts (HPLC, GC-MS, LC-MS, FT-IR, ICP, GPC, IC, Etc.)
- Identify Unknown Compounds / Characterization of Extractables
- Develop Methods to Measure Analytes in Drug Products
- Validate Analytical Method
- BPOG Protocol/Recommendations
- Toxicology Assesment
Leachable Testing Studies
A leachable study examines chemical components that can migrate from a packaging material to the product it contains under normal conditions and over the course of that product’s lifetime. Avomeen’s leachable testing process includes:
- Identifying & Quantifying All Compounds Not Found in Control Product
- If end-of-life samples are not available, we can recreate appropriate ICH stability testing conditions to generate the leachables.
- Comparing Identified Compounds to Those Found in Extractables Phase of Study
- Analyzing Results for Toxicology Issues
E&L Analysis Services Include
- Label Migration Studies
- Packaging Safety & Toxicity Analysis
- Controlled Extraction Studies for Raw Material Control
- Food Contact Notification & Migration Studies
USP Guidance Includes
- USP <87> Biological Reactivity
- USP <661> Containers – Ophthalmics – Plastics
- USP <1031> Bio-Compatibility of Materials
- USP <1663> Extractables (Pharmaceutical Packaging/Delivery Systems)
- USP <1664> Drug Product Leachables (Pharmaceutical Packaging/Delivery Systems)
- USP <1660> Glass Qualification
- USP <661.1> Plastic Materials of Construction
- USP <661.2> Plastic Final Packaging Systems
- ISO-10993 – Biological Evaluation of Medical Devices
- Toxicokinetic guidance
PH. EUR. Guidance
- Medicinal Products for Human Use Directive (2001/83/EC)
- 3.1 Raw Material Extractions
- 3.2 General Sections on Finished Containers
Common Products That Undergo Extractable/Leachable Testing
- Packaging components
- Plastics & Polymers
- Shrink wrap
- Rubbers & Latex
- Manufacturing Components