Cleaning validations examine the overall surface cleanliness of newly manufactured medical devices and disposable implants, targeting contaminants remaining from manufacturing and cleaning processes. It is important to remember that just because a device is sterile, it does not necessarily mean it is clean.
Test methods are available to measure the amount of residue (ie oils, lubricants, polishing compounds, detergents and passivation residues) on the device or implant. To give a comprehensive view of cleanliness, you can also add a cytotoxicity assessment and tests to examine microbiological contamination.
ASTM F3127 (Standard Guide for Verifying Cleaning Processes Used During the Manufacture of Medical Devices) and ASTM F2847 (Standard Practice for Reporting and Evaluating Residues in Disposable Implants) standards outline various testing options that can be included in a cleaning verification. EUROLABprovides a suite of tests that can be used together for this purpose.
A new ISO standard, ISO 19227 Implants for surgery - Cleaning of orthopedic implants - General requirements is currently being developed. This standard is expected to require total hydrocarbon (THC) analysis to be included in a cleaning validation. As an alternative to the gravimetric non-polar method, EUROLAB also offers a THC (test code HDO105) by gas chromatography method. This method uses solvent extraction and gas chromatography as specified in ISO 9377-2, Water quality - Determination of hydrocarbon oil index - Part 2: ISO 19227.
Separate sample sets are required for each test method. For test specific information, see the specific test method pages in the Working Outlines below.
Verification of cleanliness may include any of the tests listed below. Depending on the contaminants in question, a particular combination of tests will be appropriate to evaluate surface cleanliness. EUROLAB can help you design a cleaning verification package.
Extractable Residue Quantity by Gravimetric Analysis
For more information on gravimetric testing options, please see our supplementary testing guide.
EUROLAB, with its highly expert team and internationally accredited laboratories, Residual Production Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
