In our instructions for use we specify what cleaning agents are safe to use with a device and how to apply them (wipe with a lint free cloth). We have validated that the cleaning agents do not damage the device or effect performance.
Our customers are satisfied with this information.

However I was wondering, if we are specifying a simple protocol for cleaning, do we also have to specify the level of cleaning (how would you do that?), in which case we would need to validate that the level of cleaning is achieved.

Does anyone have any thoughts?

thanks
Simon

Are you writing a protocol to validate the cleaning operation? Have you already written your procedure for this? It seems you have adequate instructions for your purpose (by your statement in your post), so I'm trying to figure out what you are writing.

I would think you would generally specify how consistent cleaning is to be achieved. Too, you might want to consider a training module, where cleaning practices are observed and approved. You could have a certification/approval of sorts for those cleaning.

I am certainly not that familar with the requirement, so there may be others override what I suggested.

One of the requirements for our device is that it be cleanable by end users. However we have not created a specification for the level of cleanliness.
Hence we simply state in the product manual that the device can be cleaned by wiping with a cloth dipped in cleaning agent. This information is sufficient for the device users.

I am concerned however, that when the auditor arrives he will ask for a defined level of cleanliness and evidence that it is achieved.

Simon

Simon,

What you describe sounds more like a "sanitisation" process and feel it could be covered by a procedure. Cleaning validation generally refers to Equipment cleaning, Area Cleaning etc where you ensure the absence of the cleaning agents from the substrate until an acceptable level.

Btw, what is the intent of your cleaning and what cleaning agents do you employ ?

I'm unclear what is meant by "level of cleanliness". How would you measure this?

If you specify a process you need to have the support (objective evidence/ data) to show that it is effective. It also depends on the intended use of the device. For example if it is a reusable surgical instrument then you should look at AAMI TIR 30 or AAMI TIR 12 for guidelines.

I just went through the Protocol Development for this. The product is a medical device, not manufatured sterile, but is used and return to us under a rental program.

We went through the clean vs. dissinfected conversation - then realized we needed to be as clean as the as manufactured product. We sampled products from all stages of the process (as Mfg, as Received back, as Cleaned (3 steps)). All in all we were looking for a log reduction from the returned product vs. cleaned product. The as manufactured provided a baseline.

We considered Bioburden. However, you may want to know what the organism are in order to determine what is the correct cleaning agents - this is an option. We considered this and have a cut bleach and water solution rotation with the cleaning agents.

Hope this helps, but it all starts with what the device is used for - then you determine the level of cleanliness / dissinfection.

I would start with a standard based on what your concerns are.

example - we clean parts for oxygen service. Therefore we need to make sure there is no hydrocarbon residue. We use a couple of ASTM standards for this.
We also have some customers that require us to comply with a NASA Kennedy Space Center standard for surface cleanliness - this standard calls out levels with counts and weights of contaminent.

In the past I had to do cleaning validation for food/drug/cosmetic packaging equipment.
In that case we were looking for yeasts and molds and such as well as preventing cross contamination.