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Compatibility, Extractable and Leachable Testing

The pharmaceutical industry is required by official bodies to demonstrate that no toxic or harmful substances migrate from packaging materials into a drug during its expected product shelf life. Similarly, in single-use systems (SUS) and other consumables used in pharmaceutical production, such as filters, tubes connectors and others, there is significant interest in the investigation of potential leachables that end up in the finished drug product. Processing equipment, as well as primary and secondary container closures are potential vectors for chemical contaminants.

We provide the assessment of extractables and leachables in bio/pharmaceutical products as an important step in drug product development and materials qualification procedures.

Why choose extractables and leachables testing from SGS?

We provide a complete service for testing extractables in container materials, medical devices, single use systems and leachables in final products. Leachables tests on finished container closures are conducted in cGMP compliant laboratories using technologies that detect ultra trace levels.

We provide:

  • Test strategy planning and data evaluation based on the available information
  • Supporting of risk analysis procedures
  • Development of a tailored study design for extractables and leachables or chemical characterization, according pharmaceutical standards and ISO 10993 part 12/18
  • Extractables profiling (inorganic and organic extractables)
  • Sequential extractions and alternative extraction techniques for isolating extractables in  materials made from polymers, metals and ceramics
  • Characterization of extractables by chromatographic and spectroscopic investigations
  • Identification of a material and the identification and quantitation of the chemicals present in materials by chemical characterization
  • Identification and evaluation of the physico-chemical, mechanical, morphological and topographical properties of materials
  • Chemical and structural changes (e.g. by DSC) on polymeric materials after stressing by themperature or irradiation
  • Determination of the Analytical Evaluation Threshold (AET)
  • Calculation of the AET based on Safety Concern Threshold (SCT) or Threshold of Toxicological Concern (TTC) and ICH M7 guideline
  • Biocompatibility: USP<87> and USP <88>
  • Toxicological assessments and method development and validation of potential leachables in pharmaceutical products and from medical devices
  • Performing leachables studies or simulated use studies on pharmaceutical products and medical devices
  • Reporting and evaluation of results within the current guidelines

Extractables and Leachables Testing and Assessment Technologies

Our extractables and leachables testing and assessment technologies include:

  • Semi-preparative fraction collection by HPLC
  • Accurate mass assignments by mass spectrometry
  • Peak purity
  • GC-TEA (nitrosamines)
  • HPLC-MS/MS (ESI) perfluorinated acids (PFCA)
  • IC-ED (anions, cations)
  • FTIR
  • Accelerated Solvent Extraction (ASE)
  • Soxhlet and reflux extraction
  • Static or dynamic liquid extraction by pumping through; simulated use and migration studies 

Topographical Methods and More

We provide topographical methods and other methods for physical-chemical material characterization, surface contamination, risk of delamination or surface fracture after stressing including:

  • Thermoanalysis TGA, DSC
  • X-ray fluorescence analysis (XRF)
  • Materialography, Light Microscopy
  • Electron Microscopy (REM, SEM)
  • Atomic-force microscopy (AFM)
  • X-ray diffraction (XRD; XRT)
  • Electron Probe Microanalyzer (ESMA)
  • Photoelectron Spectrometry (XPS)
  • Auger Electron Spectroscopy (AES)
  • Spreading Resistance Profiling (SRP)
  • Secondary Ion Mass spectrometry (SIMS-Tof)

To discuss how we can help with your extractables and leachables testing and to qualify your materials fit for its intended use, contact us today.

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  • SGS Germany GmbH

Heidenkampsweg 99,

20097, Hamburg, Germany