4 replies to this topic

[qad2019]

Hi All,

 

I'm new to a company that is setting up processes to begin filling our own bottles (previously all co-packed).  We are essentially bottling various formulations of MCT oil.  My question is how often we may need to clean if we are essentially running one product (we only run one shift currently so we would be capping lines overnight if we don't do a full breakdown)?  FDA doesn't list any micro risks for coconut oil per FSMA but I'm wondering if there is any industry guidance?  Thanks!

[QAGB]

It depends on what ingredients you are using in your MCT oil. If you have any known allergens (including unrefined oils with allergenic proteins), you need to treat this with extra care. Separate lines are always best, but you would need to conduct some sort of flushing of your system and validation/verification of removal of proteins.

 

Otherwise, if everything is non-allergen, you would consider just doing a purge between runs with your base oil (which appears to be coconut oil in this case).

 

As oils don't generally have micro risks, a purging of your lines with your base oil is really what you would need. You don't want to mix oil and water together unless absolutely necessary. That really creates a mess, and could create a micro issue for you (as well as being super difficult to get your equipment dry again). 

[qad2019]

It depends on what ingredients you are using in your MCT oil. If you have any known allergens (including unrefined oils with allergenic proteins), you need to treat this with extra care. Separate lines are always best, but you would need to conduct some sort of flushing of your system and validation/verification of removal of proteins.

 

Otherwise, if everything is non-allergen, you would consider just doing a purge between runs with your base oil (which appears to be coconut oil in this case).

 

As oils don't generally have micro risks, a purging of your lines with your base oil is really what you would need. You don't want to mix oil and water together unless absolutely necessary. That really creates a mess, and could create a micro issue for you (as well as being super difficult to get your equipment dry again). 

Thanks!  I assume there is *some* interval in which we would have to clean though?  I don't want to introduce water to the process when there is none but it seems odd to me that you wouldn't have to clean eventually. 

[QAGB]

Thanks!  I assume there is *some* interval in which we would have to clean though?  I don't want to introduce water to the process when there is none but it seems odd to me that you wouldn't have to clean eventually. 

 By "clean" I assume you mean with water/sanitizer? The reason to use sanitizer & water is to sanitize surfaces in order to reduce micro growth/buildup. There are very limited opportunities for micro growth in oil (except when you start adding water). We very seldom ever introduced water into our lines unless we were blending a colored or distinctly flavored product (and it was too expensive to purge with oil) or if we somehow introduced a foreign material into our process.When we did blend colored products, we tried to keep it as minimally intrusive as possible (introducing the color at the last possible step) to prevent from having to "clean" the whole processing line. I would consider a purging of the previous run to be a cleaning process, being you're flushing out previous product and you aren't at risk for micro growth.

 

If your line sits idle for days at a time though, you might consider using some kind of cleaning agent to run through your system to prevent off-flavored oil due to increased peroxide values or free fatty acids. We didn't worry about this because we ran our lines on multiple shifts everyday.

 

We did clean Zone 2s in the area (conveyors, bottle handling equipment, etc.) everyday with sanitizer. However, there was no set frequency for "water cleaning" the hoppers, liquefiers, blenders, or product lines.

[lnahokie]

Did you guys end up setting up a ATP testing program? This is what Im struggling with deciding since we are thinking the same thing.. oil flushes only.