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Microbial Validation your container, container closure, and headspace treatment process

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MrHotSauce

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Posted 05 January 2024 - 04:57 AM

Hello All,

 

I recently submitted an SID for my hot sauce. I have included my scheduled process, but for bottle and caps cleaning process, I use method alcohol spray and UV sterilization. I have provided my process for the alcohol spray and uv sterilization, but now FDA is requesting me to provide Microbial Validation for container, container closure, and headspace treatment process. Can someone help me with this process? What kind of bacteria is need to be tested for validation purposes, and how should I write this up?

 

FDA also inquired that I provide the time gap between alcohol spray of caps and uv sterilization of bottles and filing. Currently my process are spray alcohol let the caps dry for 1 hour, then uv sterilize the bottles within 10 seconds start filling hot sauce and used the cleaned cap to close the bottle. Is this good enough for FDA? Or should it be something else?

 

Thank you in advance for all of your help.



kfromNE

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Posted 05 January 2024 - 10:43 PM

Hello All,

 

I recently submitted an SID for my hot sauce. I have included my scheduled process, but for bottle and caps cleaning process, I use method alcohol spray and UV sterilization. I have provided my process for the alcohol spray and uv sterilization, but now FDA is requesting me to provide Microbial Validation for container, container closure, and headspace treatment process. Can someone help me with this process? What kind of bacteria is need to be tested for validation purposes, and how should I write this up?

 

FDA also inquired that I provide the time gap between alcohol spray of caps and uv sterilization of bottles and filing. Currently my process are spray alcohol let the caps dry for 1 hour, then uv sterilize the bottles within 10 seconds start filling hot sauce and used the cleaned cap to close the bottle. Is this good enough for FDA? Or should it be something else?

 

Thank you in advance for all of your help.

 

You need testing data. So swab before cleaning then after cleaning - the bottle and cap. Enterobacteriaceae is the indicator organism I would use.

Though the FDA may want you to test for specific organisms - then I would use listeria. 

Another option - finding a published article proving what you are doing is safe. 

 

As for the time gap between alcohol spray and UV sterilization - you need to provide data that this is allowed. So how you come up with your initial method? You must have gotten the information from somewhere. 

 

Anytime a chemical or application is applied - the FDA and USDA will make sure it is safe. Showing you're following the instructions on the chemical/application - completely allowed. Having an email from the supplier showing what you're doing is a safe use of their product - allowed too. 

 

It seems to me you are a small manufacturer. What I would do - contact your land grant university in the state you are located. Then find the contact for small business manufacturers or food science department. They will offer advice to you to set up your process including validation. They are experts. The cost is usually minimal too. 

 

Using a professor at a land grant university and following their advice - another way to prove your process to the FDA. 





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Also tagged with one or more of these keywords: validation, microbial, container, headspace, treatment process, fda, SID, UV Sterilization, Alcohol Spray caps, validation process

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