The Applied Technical Services Family of Companies (ATS FoC) specializes in leachables and extractables testing, identifying chemical compounds that migrate from packaging, manufacturing components, or medical device materials into products. We deliver tailored testing strategies that provide reliable analytical data, enabling clients to meet regulatory requirements, minimize development delays, and reduce compliance risks.
When Should Leachables and Extractables Testing Be Performed?
Leachables and extractables testing is recommended whenever container closure systems may introduce unwanted chemical compounds into a finished product. Extractables testing identifies potential chemical migrants during material selection, while leachables studies confirm migration under actual storage or use conditions. These evaluations are commonly integrated into product development, process validation, packaging qualification, and regulatory submissions.
Common situations that require E&L testing include:
- Changes to packaging, containers, or closure systems
- Development of sensitive products or medical devices
- Material qualification for pharmaceutical manufacturing
- Regulatory submissions and lifecycle management
- Shelf-life and stability studies
Comprehensive Leachables and Extractables Testing Capabilities
Our ISO-accredited laboratory develops customized extractables, leachables, and chemical characterization studies in accordance with recognized pharmaceutical guidance, including USP <1663>, USP <1664>, USP <665>, USP <1665>, PQRI, BPOG, and ISO 10993-18:2020 for relevant medical device and combination product evaluations. We establish scientifically justified analytical evaluation thresholds (AETs), develop and validate analytical methods, identify unknown compounds using advanced spectral libraries and proprietary databases, and conduct simulated-use and shelf-life studies. Our specialists interpret and document findings to meet current regulatory expectations.
We also offer comprehensive material characterization and surface analysis to assess contamination, material degradation, delamination, and surface integrity after environmental or mechanical stress. Our capabilities include:
- Scanning electron microscopy (SEM)
- X-ray fluorescence (XRF)
- Materialography and light microscopy
- Photoelectron spectroscopy (XPS)
- Atomic force microscopy (AFM)
- Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA)
- X-ray diffraction and X-ray tomography (XRD/XRT)
- Secondary ion mass spectrometry (SIMS-TOF)
- Auger electron spectroscopy (AES)
- Electron probe microanalysis (EPMA)
- Spreading resistance profiling (SRP)
How Can Leachables and Extractables Testing Reduce Product Risk?
Leachables and extractables testing enables manufacturers to identify chemical contaminants before they affect product quality, safety, or regulatory compliance. Early evaluation of packaging materials and product-contact surfaces reduces the risk of recalls, failed submissions, stability issues, and patient safety concerns. Comprehensive testing also supports informed material selection, strengthens quality assurance, and provides documented evidence of regulatory compliance.
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Contact our experts at +1 (888) 287-5227 or submit our online webform to discuss your project and receive a customized testing solution.
