Medical Device Residual Testing

Contaminates on medical devices can lead to biocompatibility failures and complications during use, potentially putting the patient at risk. Contaminates can be introduced from a variety of different operations. Detergents and disinfectants can contaminate the device after cleaning and disinfection operations. Lubricants, oils and solvents can contaminate the device during the manufacturing process. Manufacturers should establish acceptable levels of residues on their devices based on their intended use and patient contact.

Device Cleanliness Testing

Pacific BioLabs can analyze chemical residuals on your medical device in order to provide insight into cleaning operations after production. We conduct gravimetric analysis to determine the total amount of residue coming off the device. We can use GC and GC-MS to quantify residual chemicals left over by detergents and cleaning agents and UV-Vis spectrophotometry to measure residual protein. We can analyze Total Organic Carbon (TOC) to quantify the organic carbon residues on the device left over from oils, detergents and adhesives.

Available Services for Residual Manufacturing Materials

  • GC-FID with Headspace
  • GC/MS
  • Total Organic Carbon (TOC)
  • Protein Content
  • UV-Vis Spectrophotometry
  • Gravimetric Analysis

Read More About Residual Testing

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