Cleaning Validations For Medical Devices

Pine Lake Laboratories can provide the needed analytical testing to support the cleaning validation of medical devices. We have successfully developed specific methods able to detect low levels of residual process agents as well as non-specific methods for the detection of classes of residual process agents. Examples of methods we have successfully used include:

GC-MS for volatile organic residual contaminants

LC-UV/MS for non-volatile residual organic contaminants

ICP-MS for inorganic residual contaminants Total organic carbon

Pine Lake Laboratories can perform these tests to the cleaning limits proposed by the client. If the medical device is at risk for a large number of residual processing agents, Pine Lake Laboratories recommends using a worst case scenario cleaning limit in the cleaning validation. A more detailed description can be found in the Technical Library.




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