Salt and biological hazards

Ok, I want to pick some brains on this one as my background is not in biology.

We produce 2 salts in crystal and occasionally in solution, ammonium chloride and ammonium sulfate. These are used in pharma and food applications, one of which is also used in feed applications.The aW of our product is way out of the danger zone for pathogens. I understand that only means pathogens won't flourish in the product. Based on this we also treat our packaging room as a sanitary zone, making sure to keep the spout covered with a bag at all times, keep the doors closed when not in use, and enforce heightened GMP's (bagger who handles open bag wears disposable gloves, no food/drink in this area whatsoever) on top of the standard hand washing, and other relevant GMP's.

We do not wear hairnets/beard nets in this area, nor do we perform any type of EM. These were both discussed as options in our original hazard analysis but shot down as being well outside the risk level required to implement.

What I'd like is some stronger proof that the risk is this low. Is there perhaps testing we could run on the product to show it kills pathogens, doesn't just inhibit their growth? Is there any information I'm missing that I could use as validation? 

I'm not expecting the world and we're in a pretty good place with our hazard analysis as it is, I'd just like a little more oomph on that one if possible.

My background is in food, but the first questions I would have are what are the other intrinsic factors of these salt solutions.  You mentioned water activity, but what is the acidity and pH?  It would seem if there were multiple barriers to pathogen survival or growth, then you would have a pretty strong case.  I think you want to also consider the real risks of an environmental pathogen actually being in your environment.  What are the conditions (wet, dry, cleaning/sanitizing frequency, any swabbing done ever?).  Typically in the food industry we only consider Listeria and Salmonella, but I'm not sure if you have other pathogens of concern in your environment.  Do you have any other raw materials or inputs that would bring pathogens into your environment?     

The other thing I'm wondering is if you would have the potential to sterilize the solutions once in the final packaging, or through a sterile filter when you package.  

I think you are right that the only real validation would be to actually inoculate your solutions with the pathogens of concern.  It would seem unnecessary to me, but I'm sure you could contract with a lab to do that study for you.  Probably  expensive so I would be sure that you need it.  

How long do you have the salts in your facility before release? You may be able to use some combase curves to show how long a pure salt solution would take to kill pathogens, then keep your hold period within an x log safety margin.

https://browser.comb...rchResults.aspx

If you want a less scientific and more legal validation, in appendix 1 for the preventive controls guidance chemical salts would be in the "food additives" section of biological hazards on page 23 (https://www.fda.gov/.../99581/download).

Ammonium sulfate is specifically called out, the other salt would probably fall under "processing chemicals", so you can rely on FDA for your risk assessment here.

Ok, I want to pick some brains on this one as my background is not in biology.

We produce 2 salts in crystal and occasionally in solution, ammonium chloride and ammonium sulfate. These are used in pharma and food applications, one of which is also used in feed applications.The aW of our product is way out of the danger zone for pathogens. I understand that only means pathogens won't flourish in the product. Based on this we also treat our packaging room as a sanitary zone, making sure to keep the spout covered with a bag at all times, keep the doors closed when not in use, and enforce heightened GMP's (bagger who handles open bag wears disposable gloves, no food/drink in this area whatsoever) on top of the standard hand washing, and other relevant GMP's.

We do not wear hairnets/beard nets in this area, nor do we perform any type of EM. These were both discussed as options in our original hazard analysis but shot down as being well outside the risk level required to implement.

What I'd like is some stronger proof that the risk is this low. Is there perhaps testing we could run on the product to show it kills pathogens, doesn't just inhibit their growth? Is there any information I'm missing that I could use as validation?

I'm not expecting the world and we're in a pretty good place with our hazard analysis as it is, I'd just like a little more oomph on that one if possible.

= Microbiological (Pathogen) Challenge testing.

Thanks for the replies all, I will check out the links today.

"Do you have any other raw materials or inputs that would bring pathogens into your environment?" Our ingredients are anhydrous ammonia and either hydrochloric acid or sulfuric acid. You can imagine how much of a challenge it was covering my bases on approved supplier/ingredients with our ingredients being poisons.

Thanks for the feedback all.

In addition to the micro concerns, which others here have addressed, you may want to consider hair nets and bears nets to prevent hairs from entering your product. While bacteria on the hairs may be controlled by the nature of your product, it would be unpleasant to find hair in the product.

In addition to the micro concerns, which others here have addressed, you may want to consider hair nets and bears nets to prevent hairs from entering your product. While bacteria on the hairs may be controlled by the nature of your product, it would be unpleasant to find hair in the product.

Good morning Fishlady. We (my HACCP team) actually did run a hazard analysis on that issue. The only opening in our system is the spout the product comes out of when being bagged. Our baggers wear disposable gloves and cap the end off when not dispensing product. Based on that, and that the product is dissolved into solution by our customers, the risk wasn't high enough to warrant hair/beard protection. I was prepared to challenge that with an auditor, but after they see the process they realize it's a non-issue.

In that case, it sounds like you are in good shape.