My boss has asked me to start testing our stainless steel equipment for bacteria, following it being cleaned. I don’t have a lab background and I’m getting very confused. I was hoping I could tell you what I plan to do and hope for some feedback, because I could be well off track.
We make veterinary products, but not in a cleanroom. I thought I would treat the area as if it’s a Class D environment. I would then write a risk assessment to find the worst case cleaning locations. After the equipment has been cleaned, I plan to swab 55mm areas with the following criteria:
Average 10 values in sequence: <50 cfu
Alert level: <75 cfu
Action level: <100 cfu
Do you look for particular bacteria or is it all colonies?
Would you test for endotoxins?
Is it common practice to test for cleaning agent residue as well?
For the cleaning validation, would I just swab the areas before and after cleaning, or do I need to spike the areas with a known quantity of bacteria?
I am sure everything I have just said is really dumb, but I have no experience in this area. Plus, it’s not something we technically need to do, so we can be quite flexible in what we do/do not test.
Any comments would be appreciated.
My boss has asked me to start testing our stainless steel equipment for bacteria, following it being cleaned. I don’t have a lab background and I’m getting very confused. I was hoping I could tell you what I plan to do and hope for some feedback, because I could be well off track.
We make veterinary products, but not in a cleanroom. I thought I would treat the area as if it’s a Class D environment. I would then write a risk assessment to find the worst case cleaning locations. After the equipment has been cleaned, I plan to swab 55mm areas with the following criteria:
Average 10 values in sequence: <50 cfu
Alert level: <75 cfu
Action level: <100 cfu
Do you look for particular bacteria or is it all colonies?
Would you test for endotoxins?
Is it common practice to test for cleaning agent residue as well?
For the cleaning validation, would I just swab the areas before and after cleaning, or do I need to spike the areas with a known quantity of bacteria?
I am sure everything I have just said is really dumb, but I have no experience in this area. Plus, it’s not something we technically need to do, so we can be quite flexible in what we do/do not test.
Any comments would be appreciated.
Cheers![/quote]
First if you don’t need to do it, I would be careful as you may be setting yourself up for future issues.
Before you start a cleaning validation and micro sampling do you a have an SOP that tells you how to go about it? Is it tested in house, do you send it to a qualified lab for testing? Will you also be doing hold/clean time studies? If not I would suggest starting with a cleaning SOP so that way you have a template for what should be included in your protocol.
Carefully plan it out because once you put it to paper you can’t just throw it away if you don’t like what you find.
What you test for should be based on what growth or other risk factors are assoicated with the process/product.
Firstly I would like to welcome to the site. Secondly, I would make new thread for this question as it is not applicable to the topic being discussed here. Additionally, more information would be needed. I am assuming this is for a blistered product, also 300 is in what measurement of pressure? This should and other important details be included in your new post so myself and other members may be able to help.