Extractables and Leachables Testing

Regulatory agencies require biopharmaceutical manufacturers who utilize drug delivery devices, single-use manufacturing systems, and container closure apparatuses to submit toxicological Risk Assessments based on chemistry data generated by extractables and leachables testing. All testing is designed to support drug manufacturers from early stages through to commercial batch release in compliance with ICH guidelines and FDA/EMA regulations.

Through investment in technology and expertise, we have developed a multi-tiered analytical methodology to extractables and leachables testing that provides complete chemical characterization, enabling accurate assessment of any potential hazards.

Our Approach to Complete Chemical Characterization and Risk Assessment

Consultation
Our experts meet with you to gain a thorough understanding of your product and process such as testing objectives, past experiences with outsourcing, materials, patient population, route of administration, and exposure.
Protocol Selection
Select preferred industry study protocol; BPOG, BPSA, USP 665, or hybrid. Watch an on-demand webinar that demonstrates our approach to designing a modified BPOG protocol. 
Testing - Full Range of Chemical Detection
Test maximum limits of extractable chemicals utilizing the following instrumentation

  • Headspace Gas Chromatography (with mass spectrometry) for analysis of volatile organic compounds
  • Direct inject gas chromatography (with MS) for analysis of semi-volatile ¬†organic compounds
  • Liquid Chromatography (with MS) for analysis of non-volatile organic compounds
  • Inductively coupled plasma for elemental analysis
Chemical Identification
Leverage proprietary LC/MS database, commercial databases, literature, and mass accurate data to search, match and identify all chemicals detected.
Risk Assessment Report
Experienced Toxicologists on staff review the numbers and prepare Risk Assessment Report that includes calculations of risk based on intended use and discussion/interpretation of entire data set. Learn more about our approach to Risk Assessment.

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Discuss a tailored E&L study with our team of experts.

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