Whitehouse Laboratories technical experts in Cleaning Validation provides support to our clients with our analytical and support services. Our personnel can assist you in validating your cleaning process to ensure that cross-contamination, contamination, and residuals are removed. FDA requires that Cleaning Validations are performed for changes in procedure, equipment, formulations, and cleaning procedures as they have a direct impact on the finished product. Dependent on the product, sampling techniques can include rinsing, swabbing, or other specific practices. Our technical experts assist our clients in developing and validating analytical methods. These methods will address critical attributes such as precision, linearity, recovery, LOD, and LOQ. In addition to developing analytical methods, non-specific methods such as Total Organic Carbon (TOC) can be utilized for detection of all carbon containing compounds that are soluble in water. TOC results can not specifically identify the residual compound, but the sensitivity allows results to be obtained in the ppb range. Both methods may be used in routine analysis of cleaning validation samples.
- 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