An Easy to Understand Guide to Cleaning Validation

An Easy to Understand Guide - Cleaning Validation

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[quote=gokeeffe]An Easy to Understand Guide - Cleaning Validation

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Dear Gokeeffe, Hello

For cleaning validation in my pharmaceutical company I have prepared a matrix for each production train where I follow the production of all products produced on the machines and using the solubility of each active substance in water and the minimum therapeutic daily dose, I then give weights for each active and find the worst case. I have been recently asked to calculate the solubilities in different solvents which are used as detergents like sodium lauryl sulphate. I am finding it very hard to find the solubilities of substances in sls, can you advise what to do?

Do you have a lab capable of testing to provide this data? Nothing beats actual scientific data in the agencies eyes.

I believe it is very unpractical to actually test it in the lab. I have more than 200 products some of which have more than 1 API. Do you think it is a logic thing for the agencies to ask for especially that we use both hot water and then SLS and then water again and finally 70% alcohol for washing our machines.

So it would make sense that there are most likely some API’s that are used in more than one product, such as acetaminophen, where you can test the API once and use the data. The risk you run is not having any scientific rationale that says what you clean with does indeed remove the soils. I know it seems impractical, but when it comes to product safety, the agency is not going to budge. If you consider that you are cleaning over 200 different products with water and 70% IPA as your cleaning agents, there is little precedent that demonstrates that IPA is that great of a cleaning agent. A thought to balance out the cost on the lab testing of all of the products would be that you could test to show what you can lump together for cleaning agents and then establish the worst case soils and reduce the amount of cleaning validation testing that is required. This would allow for future products to be tested in the lab before rolling into production to compare it to the worst case soils, and possibly lump it in under with only one cleaning verification run. While you think it is more expensive to get the lab to provide all of the testing that you need to be defendable, ask yourself how costly it would be to have to do it under a warning letter with lots of 3rd party consultants showing you how to do it right?

Thanks alot for your reply, you gave me the sense of obligation to follow these requirements even if I am not 100% convinced!!! I will test them in the lab. :slight_smile:

I am glad I could show you the rationale behind the need. I would certainly think you would appreciate this if you are the person having to sit with the auditor and you have the confidence to defend your work. I can honestly say that I have been in and out of places that are under warning letters and Consent Decree and they did not have this data. I am sharing with you what I have learned and I do believe completely in this. If you do still have doubts, do as I do regularly, consult the available guidance from the agencies. You can’t go wrong having supporting data. From what I have seen in places that were on top of their game, when you start backing up everything with data the auditors will smile and go away with little comment. It is much nicer to have them smile knowing you get it than to have them sit there with a blank face. What many people do not realize is the FDA put out guidance in September of 2006 on Quality Systems and essentially said that if the System maturity shows that it is in control of things and continuing to grow, then they will not be around as frequently. Having a robust program supported with science is a significant part of that maturity.

Does it contain also information on how to test complex equipment where you do not have a straight forward 10x10 surface for swapping?
And if you can’t swap, what possibilities there are to proof that your equipment is actually clean. Cause rinsing to a certain TOC or conductivity isn’t (any more) accepted as a proof that the system is actually clean.

Thanks for some feedback…


Hi Q-Jo,

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Hello Keeffe
Sorry but there is no straight forward information whether the topic I raised is covered.

As this is a book for people new to cleaning validation I would think that, that specific question is not covered.

Maybe you could post in the forum instead.