Our technical experts will validate your cleaning process to ensure the removal of cross-contamination, contamination and residuals. The FDA requires that cleaning validations are performed when changes occur in the procedure, equipment, formulations and cleaning procedures because they have a direct impact on the finished product. Sampling techniques can include rinsing, swabbing and other product-specific practices.

We assist you with the development and validation of analytical methods, addressing critical attributes such as precision, linearity, recovery, LOD and LOQ. In addition to developing analytical methods, we can also apply nonspecific methods such as total organic carbon (TOC) for detection of all carbon-containing compounds that are soluble in water. The sensitivity of TOC obtains results in the ppb range. We use both methods in routine analysis of cleaning validation samples.

Our cleaning validation methods include:

  • Total Organic Carbon
  • ASTM F2847 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
  • ASTM-F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
  • ASTM F1877 Standard Practice for Characterization of Particles

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