The Applied Technical Services Family of Companies (ATS FoC) is an ISO-accredited extractable and leachable testing laboratory. We help pharmaceutical, medical device, biotechnology, and packaging manufacturers ensure product safety and regulatory compliance through extractables and leachables testing. Our laboratory provides analytical services to identify and characterize compounds that may migrate from packaging, manufacturing components, or medical devices into pharmaceutical or other sensitive products.
Why Should Manufacturers Invest in Extractables and Leachables Testing?
Extractables and leachables testing evaluates how packaging, closures, and container materials interact with products. Extractables testing identifies compounds removed by aggressive solvents or elevated temperatures, while leachables studies determine which substances migrate into products during normal storage and use. Manufacturers use these tests for product development, material selection, process validation, regulatory submissions, and quality assurance. Comprehensive testing also helps identify contamination sources before they impact product performance, patient safety, or shelf life.
About Our Extractables and Leachables Testing Lab
Our ISO/IEC 17025-compliant laboratory offers customized testing programs for pharmaceutical, biotechnology, and medical device manufacturers. We design extractables, leachables, and chemical characterization procedures according to industry guidance, including USP <1663>, USP <1664>, USP <665>, USP <1665>, PQRI, BPOG, and ISO 10993-18. Our scientists support all stages of testing, from study planning to final reporting, and deliver reliable data for regulatory submissions and product qualification.
Our core E&L services include:
- Analytical Evaluation Threshold (AET) determination
- Comprehensive analytical reporting and data interpretation
- Customized extractables and leachables study design
- Method development and validation
- Simulated-use, accelerated aging, and shelf-life leachables studies
- Unknown compound identification and structural characterization
In addition to chemical characterization, our laboratory performs advanced material and surface analyses to evaluate composition, contamination, coating performance, and the potential for delamination or surface degradation after environmental or mechanical stress. These techniques provide a comprehensive understanding of material integrity and long-term product performance.
Our material characterization capabilities include:
- Atomic Force Microscopy (AFM)
- Auger Electron Spectroscopy (AES)
- Electron Probe Microanalysis (EPMA)
- Optical Microscopy and Scanning Electron Microscopy (SEM)
- Spreading Resistance Profiling (SRP)
- Thermogravimetric Analysis (TGA) and Differential Scanning Calorimetry (DSC)
- Time-of-Flight Secondary Ion Mass Spectrometry (TOF-SIMS)
- X-ray Diffraction (XRD) and X-ray Tomography (XRT)
- X-ray Fluorescence (XRF)
- X-ray Photoelectron Spectroscopy (XPS)ent.
Contact Us
Submit a web request or call +1 (888) 287-5227 to discuss your project, request a customized testing program, or learn how we can support your product’s successful market entry.
