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Pharmaceutical and Product Testing

By February 26, 2022General

As a food, dietary supplement, or personal care product manufacturer, your products are expected by the public and by regulatory bodies to be safe for use and consumption. But what is safe, exactly? Product safety can involve everything from how the product is labeled (if it contains gluten, does your label state that?) to whether pathogenic microorganisms are present in your product. There are entire publications dedicated to ensuring a high-quality finished product, so we are going to focus here on how to determine whether your product meets microbiological guidelines for human use and consumption.

This is one area where we at Daane Labs field a ton of questions because the guidance available from regulatory bodies like the FDA is pretty vague. Our clients want a list of organisms to test for and the acceptable levels. We hate to be the bearer of bad news, but no such lists exist. It’s up to you to develop that list and those levels, called product specifications, for your product yourself. But don’t worry! This blog post isn’t over yet and we’re here to help you develop those specifications for your products.

Big picture: your individual product specifications should be a reflection of the nature of your product. This includes everything from raw ingredient quality, manufacturing process, packaging, storage conditions, intended use, etc. You should have a solid understanding of what the lifecycle of your product is to be able to make the most comprehensive, competent decisions about what to test for and how. Let’s start with a a couple examples of what product specifications may look like and we’ll work our way backwards on how we got here:

Example 1 – Turmeric Capsules
Organism Specification
Total Aerobic Count <10,000 CFU/ gram
Total Yeast & Mold <1,000 CFU/ gram
E. coli Negative in 10 grams
Salmonella spp. Negative in 10 grams

In the above Example 1, this product would be “allowed” to have up to 10,000 CFU/g total aerobic organisms, up to 1,000 CFU/mL yeast and mold, and no E. coli or Salmonella spp. at all. 

Example 2 – Eye Drops
Organism Specification
Total Aerobic Count <10 CFU/ mL
Total Yeast & Mold <10 CFU/ mL
Total Coliform <10 CFU/ mL
E. coli Negative in 10 mL
Salmonella spp. Negative in 10 mL
Pseudomonas aeruginosa Negative in 10 mL
Burkholderia cepacia Negative in 10 mL

In Example 2, the levels are much more stringent for the quantifiable organisms and there are additional pathogens, Pseudomonas aeruginosa and Burkholderia cepacia, that must be confirmed absent in the product.

So — why the difference? You would think that if Pseudomonas aeruginosa is a no-go in one product it should be a no-go in all products, right? You’d be right, but with a caveat. The nature of your product will determine the likelihood certain organisms will be found there, thereby often rendering testing for certain organisms wasteful. For example, Pseudomonas aeruginosa and Burkholderia cepacia are both Gram-negative rods heavily associated with industrial water systems. If your entire manufacturing process is void of such a system, such as dry-blending and filling turmeric capsules, you would waste a lot of money testing for waterborne organisms. Manufacturing eye drops, on the other hand, would require industrial deionized water systems and would therefore risk introducing waterborne organisms into the product.

Now that we’ve covered how to determine which organisms to test for, we’ll get into how to set those levels for things like Total Plate Count. This will ultimately be decided, again, by the nature of your product. Herbal dietary supplements are an excellent example of this principle. The American Herbal Products Association (AHPA) has specification recommendations for “powdered botanic extracts” as high as 10,000,000 CFU/ gram for total aerobic plate count. Such a high level of microbial activity is considered acceptable because the product contains “dirty” raw plant material. Setting the quantitative specifications depends on the microbiological activity of the ingredients going into the product, whether the product undergoes any sort of pasteurization or sterilization, at what temperature the product is stored and used, etc. You may even find it useful to run several repeat tests on your ingredients and finished product to get baseline values for microbes in the product, and set specifications accordingly. 

Whether the presence of bacteria or fungus is an inherent property of the product, such as turmeric capsules, or an acceptable risk that can be mitigated, it is important to understand all of the challenges your product faces. There are a variety of quantitative and qualitative methods that have been published by the USP, FDA/ BAM, AOAC, and more, and we perform many of these methods here at Daane Labs. If you are struggling with method selection, the team at Daane Labs are experts in current methodologies and we are always happy to help our readers make the best scientific decisions you can for your business.

Since Daane Labs is a testing laboratory rather than a testing consultant, we are unable to direct you on what your product specifications should be. What we really want you to know is that as long as your specifications are guided by a comprehensive understanding of your product and you have documented reasons for testing plan, you’re on the right track. Regulatory bodies want to see that you know the risks to your product and that you are doing your due diligence to prevent those risks from reaching the public. 

Disclaimer: Daane Labs does not set product specifications and the content of this blog post is not intended to set specifications for any existing or future products.

References

http://www.ahpa.org/Portals/0/PDFs/Policies/14_0206_AHPA_micro_limits_comparisons.pdf