Hi, I’m inquiring about residue limits for cleaning agents as per a regulatory guideline or research literature.
Over 30 people viewed this post and no one can give any info on where I can get regulatory guidelines or research literature regarding the limits for residue of cleaning agents. So everyone that is a validation officer/manager/expert cannot even shed more light on this subject.
Limits for cleaning agents usually are based off of the LD50 of the cleaning agent. Regulatory guidelines are very general and maybe this is why nobody replied and the fact that if you research other threads you might find the answer or the owner of this forum would like you to buy his book - ha ha just kidding. I would start with the manufacturer of the cleaning agent they are very generous and can help you with method developement, limits and etc…
Thanks valqueen, I’ve been in contact with my cleaning agent supplier but unfortunately they cannot assist me. The limits I’m talking about is something similar to the allowable limits for allergens (this I know is only applicable in the Food Industry) or for Micro.
For starters, this approach will most likely not garner a lot of desire to entertain your question. There are some talented people drifting through this site and I would think that they would most likelyskip right over because of the attempt at a guilt trip. With that said, I would like to inquire about the reasoning for your question? Is your desire to find this in response to a failure in a cleaning and to assess the impact to the safety of the products, or are you trying to use this to set your normal acceptance criteria? If it is the latter, I would say that this is not a good way to proceed. Instead of trying to set your criteria to say it is OK to leave this little bit on the process equipment, why not establish that no cleaning agent left is the acceptance criteria? I know for a fact that most companies that make cleaning agents for this type of cleaning publish the information for the TOC and conductivity curves of their products. Not only do they give you the information you need to establish these criteria, but they usually have already done extensive testing to demonstrate that their products can be easily removed in water alone. I have worked with Steris products at many sites and have found them to be very cooperative in providing the scientific data to support this as well as the fact that many companies in the industry use these products so it is easily understood by the auditing bodies. From the perspective of trying to demonstrate that you have removed the cleaning agents, the conductivity reading is commonly accepted and would need little effort to explain in an audit. I recently have been working with clients that have gone the route of trying to establish residue limits and testing specifically for them and they have not faired well with the FDA in trying to defend their limits verification for demonstration of clean. The problem comes from putting your blinders on and saying that the absence of the EDTA marker means the equipment is clean and completely misses the biofilm growing in the equipment. Hey you can try to buck the industry standard, but I can assure you that the agencies will have a great deal of fun tearing you up for it. Just Saying…