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, beverages, pharmaceuticals, medical devices, cosmeceuticals and dangerous goods.

Leachable Testing

E&L studies detect and identify the organic and inorganic compounds that may be inadvertently released by additives, catalysts, degradants, dyes, plasticizers, stabilizers or your products container or closure materials and absorbed into the products they contain.  Additives often can cause this release within a plastic or from low molecular weight components present in some polymer, monomer and rubber compounds.

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.  This type of testing is critical for the pharmaceutical and medical device industries where packaging safety and toxicology studies are required for product registration.  Let us help guide you through the process to access the extractables and leachables in your bio/pharmaceutical products.

Tired of being limited to having your projects completed under one-size-fits-all protocols? Our skilled chemists understand the science behind extractable & leachable methods at an in-depth level and have extensive experience working on FDA approvals.  This flexibility instead of exclusively sticking to a rigid protocol saves you time and costs through our staff’s ability to modify and customize protocols based on your particular products.

Avomeen’s E&L Chemists Specialize In:

  • Extractable/Leachable Evaluations
  • Extractable Screening (Intelligent Planning for Materials Selection)
  • Ensure Compatibility of Drug & Container/Closure
  • Method Development & Validation for Leachables Study
  • Develop Routine Extractable Control Methods
  • Ensure Safety Relative to Packaging Adulterants That Might Enter the Supply Chain

Avomeen will work with you to develop a customized testing protocol to address requirements for 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.

Extractable Testing Studies:

  • 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:

  • 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

EnL Analysis Services Include:

  • Label Migration Studies
  • Packaging Safety & Toxicity Analysis
  • Controlled Extraction Studies for Raw Material Control
  • Food Contact Notification & Migration Studies

USP Guidance Including

  • 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 Guidance

  • 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
    • Inks
    • Adhesives
    • Elastomers
    • Shrink wrap
    • Cartons
    • Rubbers & Latex
  • Manufacturing Components
    • Tubing
    • Filters

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 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 consultation:

Click Here for our online E&L Study Quote Request form (RFP)
Call: 800-930-5450
Email: scientist@avomeen.com