Residual Manufacturing Materials

Contaminates on medical devices are rising concerns to manufactures as they may lead to biocompatibility failures or potentially put the patient at risk. Contaminates can be launched from a variety of different operations including the detergents and disinfectants used in the cleaning and disinfection operations and the lubricants, oils, or solvents used during the manufacturing process. Therefore, it's necessary for manufacturers to build on appropriate levels of residues on their devices based upon the intended use and patient contact condition.

Cleaning validations examine the cleanliness of the overall surface of newly manufactured medical devices, targeting contaminants remaining from the manufacturing process, analyzing chemical residuals, and providing insight into cleaning operations after production. It should be kept in mind that just because a device is sterile, this doesn't mean it's essentially clean.

Standard for Cleaning Validation

"Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices" and "Standard Practice for Reporting and Assessment of Residues on Single Use Implants", the standards ASTM F3127 and ASTM2847 outline the principles and approaches that are intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations when manufacturing the sterile drug and biological products and conducting a cleaning validation. "Implants for surgery – Cleanliness of orthopedic implants – General requirements", a new ISO standard ISO 19227 is now in development, this standard is going to require a total hydrocarbon analysis in cleaning validation.

Our Residual Manufacturing Materials Test Service

• Organic Carbon Assessment
• Detergent Residuals Assessment
• Particulates Assessment
• Cytotoxicity Test
• Bioburden Test
• Endotoxin Test

Test Methods

• Gravimetric Analysis

  The total amount of Extractable Residue coming off the device can be determined by performing gravimetric analysis.

• GC and GC-MS

  GC and GC-MS method will be used to quantify residual chemicals left over by detergents and cleaning agents.

• UV-Vis Spectrophotometry

  UV-Vis spectrophotometry is used to measure residual protein.

• Total Organic Carbon (TOC)

  Total Organic Carbon (TOC) can be adopted to quantify the organic carbon residues on the device leftover from oils, detergents, and adhesives.

STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks with extensive expertise. If you have additional questions about Medical Device Residual Manufacturing Materials studies or would like to find out more about our services, please feel free to contact us.