Cleaning Validations for Newly Manufactured Devices
Cleaning validations examine the overall surface cleanliness of newly manufactured medical devices and single-use implants, targeting contaminants remaining from the manufacturing and cleaning processes. It’s important to keep in mind that just because a device is sterile, it doesn’t mean that it is necessarily clean.
Test methods are available to quantify the amount of residuals (i.e., oils, lubricants, polishing compounds, detergents, and passivation residuals) on the device or implant. To give a comprehensive view of cleanliness, you can also include a cytotoxicity assessment and tests to examine the microbiological contamination.
The standards ASTM F3127 (Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices) and ASTM F2847 (Standard Practice for Reporting and Assessment of Residues on Single Use Implants) outline a variety of test options that can be included in a cleaning validation. Nelson Labs offers a package of tests that can be used together for this purpose.
A new ISO standard, ISO 19227 Implants for surgery – Cleanliness of orthopedic implants – General requirements, is currently in development. This standard is expected to require a total hydrocarbon (THC) analysis be included in a cleaning validation. As an alternative to the Gravimetric nonpolar method, Nelson Labs also offers a THC via gas chromatography method (Nelson test code HDO105). This method is compliant with ISO 9377-2, Water quality – Determination of hydrocarbon oil index – Part 2: Method using solvent extraction and gas chromatography, as specified in ISO 19227.
Applicable Standards
- ASTM F3127
- ASTM F2847
