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Test soils for cleaning process monitoring

A cleaning process is more complex than a sterilization process. The apparent advantage over sterilization is that failure of the cleaning process can in some cases be detected by visual inspection. However, there is always the danger that harmful residues for the patient cannot be detected on the medical device (MD) either with the naked eye or a magnifying glass, or with other methods. The remaining contamination can either fall below the detection limit or be on a complex MD at a location that cannot be seen. Since the routine monitoring of the cleaning process on the MD itself is very difficult in everyday life, it is more important to monitor the process parameters of the validated cleaning process in order to immediately detect changes.

The number of national and international standards for cleaning process monitoring is currently still significantly lower than it is for sterilization processes. Also for cleaning process indicators, there is currently no valid standard available defining the minimum specifications. Due to the large number of cleaning parameters that can influence the success of the process, the definition of minimum requirements for indicators is a complex task that heavily depends on e.g. the load, washer-disinfector machine, detergent used and must be handled individually.

Checking cleaning properties under defined conditions (beyond the scope of accreditation)

The characteristics of test soils during the cleaning process depend on numerous process parameters. A comparison of e.g. different test soils or cleaning detergents for a defined process is only possible if all other process parameters are monitored and kept absolutely constant during comparative measurements. This is very difficult to implement in a commercial washer-disinfector.

We have developed a test equipment with identical test conditions over time to be able to compare the wash-off characteristics of different cleaning process indicators/test soils. Also, the cleaning performance of a detergent with respect to a particular substance or test soil can be reproducibly examined and the influence of cleaning parameters (temperature, time, chemistry, mechanics) can be described.

We are happy to offer individual tests (due to missing standards beyond the scope of accreditation).

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