Detergent Residuals by UV Vis Spectroscopy
This Detergent Residual Analysis test uses ultraviolet-visible (UV/Vis) spectroscopy to ensure the removal of agents used in the cleaning process. It’s important to have a robust cleaning process for medical devices; however, some steps in the cleaning process have the potential to add and leave behind residues. Examining products and devices for residues is essential for patient safety.
This test offers a way to quantify a worst-case amount of detergent left behind on the surface of the device after cleaning.
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.
|RMM205||Residual Manuf. Material: Soap/Detergent Residuals, Validation||Add|
|RMM210||Residual Manuf. Material: Soap/Detergent Residuals, Quant.(UV Vis)||Add|
|RMM220||Residual Manuf. Material: Soap/Detergent Residuals, Analy. (UV Vis)||Add|
RMM205 - Residual Manuf. Material: Soap/Detergent Residuals, Validation
RMM210 - Residual Manuf. Material: Soap/Detergent Residuals, Quant.(UV Vis)
RMM220 - Residual Manuf. Material: Soap/Detergent Residuals, Analy. (UV Vis)
RMM210: At least one sample set + ~1 gram of detergent being analyzed (Samples may be pooled or tested individually)
RMM220: At least one sample set + ~1 gram of detergent being analyzed (Samples may be pooled or tested individually)
Study OutlineThe Detergent Residual Analysis by Ultraviolet-Visible Spectroscopy test can detect contaminants in the cleaning process that readily absorb ultraviolet and/or visible light, such as detergents. In this method, water is used to perform a device extraction in which the surface residues are removed from the device. Aliquots of the extract are analyzed on the UV/Vis spectrophotometer and compared to a calibration curve of the individual detergent.
Each detergent will absorb light differently; therefore, each individual detergent must be validated on the instrument to ensure it can be detected with the test method. Not all detergents can yield an appropriate curve on the instrument, and there are some detergents that will not work with this test method. It’s important to verify before testing whether the detergent in the process has been previously validated.
Typically only final, clean samples are examined for detergent residuals. However, it’s also an option to determine the extraction efficiency by performing a spike recovery or exhaustive extraction on a dirty or unrinsed device.
A spike recovery can be performed by providing a clean sample and exposing or spiking the sample with a known amount of the detergent. One extraction is performed to determine how much detergent can be recovered using the test method.
If the exhaustive extraction method is requested, a dirty or unrinsed device is examined and extracted exhaustively to determine how much residue is can be removed from the device. Dirty or unrinsed in this case will refer to a positive control device that has been exposed to the normal amount of detergent it would see in a typical cleaning process, and then pulled from the cleaning line before the detergent has been rinsed.