Cleaning validation of isolators


I would like to know if cleaning validation of isolators must be treated in the same manner as other equipment like reactors or filling machines where the product is in direct contact with the surface.

In the case of reactors and filling machines, we check the absence of cleaning agents as well as the product. Should it be the same criteria for the isolators?

If we use an isolator because the product cannot tolerate contamination (either because the product of interest is unsafe) and therefore needs isolation, is the cleaning validation required at the same level as the reactors and filling machines? or even more, is the cleaning validation required?



I read your post and am currently looking at writing a validation protocol for pharmaceutical isolators for closed system manipulations.

I am having similar problem to you and was wondering if you got any usfull information on the topic.

Thank you.

Currently I am working with Isolators and I found that if we have to do the cleaning validation of Isolator we have to follow the same method as such for the others. We have to put the sterilised container inside the isolator chamber by means of Beta ports.

Great question! In most cases, isolators would be considered to be indirect product contact as opposed to fillers and reactors. I would treat residual cleaning agents on the intenal isolator surfaces in the same manner as the walls in a Class A fill suite. Since there is no direct product contact, surface residues are much leass of a risk.

I also do agree with Mr. Sfossier,

The method & approach will reamin same as in the cleaning validation of equipments, however relaxed scientifically rationalized limit for surface sampling of Isolater Surface can be implemented.

Happy Reading !