The manufacturing process of various medical devices – from surgical instruments to blood contacting devices and implants – includes one or more cleaning steps in order to remove particulate matter as well as chemical or biological contaminants.
The cleaning process may include different techniques (e.g. ultrasonic baths, floating and rinsing, wiping, plasma cleaning, etc.), and cleaning agents, leading to possible contamination. The device design itself (e.g. crevices, clamps or joints, rough and irregular surfaces) may also be a source of risk.
Within the scope of the biological risk assessment, according to ISO 10993-1, the efficiency of the cleaning process has to be evaluated by the manufacturer. The first step within the development of validating the cleaning process is an analysis of potential contaminations and a detailed description of the cleaning process and the chemistry used. In the second step, suitable testing methods are chosen, and the required sample size, as well as the acceptance criteria for the individual medical device, are determined. The Eurofins Consulting team offers a new service that supports manufacturers by preparing the cleaning validation strategy, considering the intended use of the device, as well as applicable guidelines and regulations, such as ISO 19277, DIN/TS 5343, ASTM F3127, AAMI TIR 42.
Our consultants further offer gap analysis of pre-existing validation plans. The team also supports medical device manufacturers in case of any change (to the device itself or to the manufacturing and cleaning processes) by evaluating their impact on the cleaning validation.
Eurofins Consulting not only offers cleaning validation services, but also cleaning services since the recent acquisition of Eurofins Inpac Medizintechnik and Eurofins Steripac in Germany. These sites offer in-house solutions for cleaning (amongst other services like sterilization or packaging) with highly effective automated qualified equipment and validated procedures within their ISO class VII clean rooms. For more information about services for medical device documentation and evaluation, visit: www.eurofins.com/medical-device.