Extractables & Leachables Testing (E&L Studies)
Controlled extractables and leachables analysis, also known as E&L studies are utilized to test a product’s packaging within a variety of industries including foods, pharmaceuticals, medical devices, and dangerous goods.
These studies detect the organic and inorganic compounds that may be released by your packaging materials and absorbed into the products that they contain. This release is often times caused from additives within a plastic or from low molecular weight components present in some polymer and rubber compounds.
Avomeen’s 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. This type of testing is critical for the pharmaceutical and medical device industries where packaging safety and toxicology studies are required for product registration.
Avomeen’s E&L Chemists Specialize In:
- Extractable/Leachable Evaluations
- Extractable Screening (Intelligent Planning for Materials Selection)
- Ensure Compatibility of Drug & Packaging
- Method Development & Validation for Leachables Study
- Develop Routine Extractable Control Methods
- Ensure Safety Relative to Packaging Adulterants That Might Enter the Supply Chain
We will work with you to develop a customized testing protocol to meet your regulatory requirements. Whether your need is for a pharmaceutical packaging or medical device registration, a label migration study, packaging analysis for food contact materials, or simply consumer product testing to determine the presence of unknown contaminants such as Bisphenol A (BPA) or Phthalates such as DEPH, our experienced chemists can solve your extractables and leachables testing needs.
- Extraction Utilizing PQRI Protocols
- Analyze Extracts (HPLC, GC-MS, LC-MS, FT-IR, ICP, GPC, IC, Etc.)
- Identify Unknown Compounds
- Develop Methods to Measure Analytes in Drug Products
- Validate Analytical Method
- Identify & Quantify 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
- Compare Identified Compounds to Those Found in Extractables Phase of Study
- Analyze 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<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 receive Extract / Leach Evaluations:
- Packaging components
- Plastics & Polymers
- Shrink wrap
- Rubbers & Latex
- Manufacturing Components
Extract/Leach – Case Study
Problem: Manufacturer Validation
Solution: To increase their profit margin a baby food manufacturer wanted to switch from glass jars to plastic bottles to market its product. The client was concerned that this would create safety issues as plastics are known to leach chemicals such as plasticizers and other additives. The manufacturer had identified three vendors that supplied appropriate types of plastic bottles. The challenge was to identify which of the supplier’s plastics bottles would release the least amount of chemicals. Our scientists performed an extractables and leachables testing study by exposing the plastic bottles full of baby food to temperatures and environments that simulated its potential real life storage conditions.
The leached chemicals were then identified and quantified at parts per million level using techniques including LC/MS and GC/MS. The study identified the supplier with the safest plastics packaging, this allowed the baby food manufacturer to confidently make the switch from glass to plastic containers for their product line.
Contact Avomeen to arrange a free initial consultation with one of our Ph.D. chemists.
Click Here for our online E&L Study Quote Request form (RFP)