Residual Manufacturing Materials (RMM)
With the increased awareness of the potential dangers of residual manufacturing materials on medical devices, the Food and Drug Administration (FDA) commonly requests documentation of a thorough validation of the cleaning processes used to remove these materials from newly manufactured devices. Nelson Laboratories, Inc. (NLI) provides several choices for these validations, including Total Organic Carbon (TOC) analysis, soap/detergent residual analysis by Ultraviolet/Visible (UV/VIS) Spectroscopy, and gravimetric analysis.
Optional Tests for Residual Manufacturing Materials (RMM)
Residual Manufacturing Materials: Quantification of extractable residue ASTM F2459
The cleanliness of medical devices, both permanent implants and single-use devices, needs to be assessed in order to minimize potential adverse biological responses to surface contamination or extractable residue. This test method is intended for use with newly manufactured medical devices. It is not intended to evaluate residues on medical devices that have been cleaned for reuse. This test method does not advocate an acceptable level of cleanliness.
Residual Manufacturing Materials: Soap/Detergent residuals
Detergent residual studies are performed on devices that have gone through cleaning processes. This method may be used with any solution which is sensitive to ultraviolet or visible light. The method is quantitative but not qualitative. The recorded absorbance of the sample extract is assumed to be entirely due to the detergent under test (even though it may not be), and the reported concentration of detergent is calculated based on this assumption. This constitutes a worst-case scenario for the detergent under test. This method does not identify the absorbing substance(s) in the extract.
The sponsor must provide a detergent for comparison. A validation must be performed for each detergent to verify precision, accuracy, and ruggedness and to determine the limit of detection and limit of quantitation.
