Question: Can you test the potency of my multi-strain probiotic blend?  Answer: Yes. And, while this is a commonly-asked question we find very easy to answer, the process for testing probiotic blends isn’t so simple.
Since testing probiotic blends is complicated, we recommend testing potency by plate count methods that report in Colony Forming Units or CFU/g.  Labeling and testing in CFU/g, instead of mg or weight, is the best and most accurate way to verify the potency of probiotics.  These methods account for the live bacteria in the product, which measuring by mg or weight does not.  Labeling the product by weight will not ensure the specific attributes for the health benefit that is intended.
In early 2017, CRN and IPA released the Probiotics Best Practices Guidelines.  These voluntary guidelines outline labeling, stability testing and storage recommendations for probiotic products.  These best practices are intended to create consistency with products and transparency across the industry, and they also clearly recommend the CFU/g labeling for potency claims of probiotics.
It is commonly understood that testing probiotics is challenging.  That is why we work with raw material manufacturers to be proficient with their methods for their specific probiotic strains.  The Food Chemical Codex (FCC) has included some probiotic methods in their compendia, helping to improve method standardization.  For a lab like ours, this means we are required to keep multiple medias and agars on hand for the samples sent to us for testing. And although so many different methods are requested, rest assured that we keep the lab supplied and ready for your samples!
Unfortunately, the methods for enumeration are developed for raw materials and are not usually designed for probiotic blends.  Once the strains have been blended together, they become like scrambled eggs and cannot be enumerated separately.  When running one CFU/g method for the blend, the goal is to show the full combined potency. When testing a blended product, we will look at it as a whole to determine which single method may be best to quantify multiple probiotics in the formula.   Since each method uses a specific agar and media for best growth of that strain, not every strain may grow on every media.  We also look at co-ingredients, such as botanicals or other non-probiotic ingredients, that could affect the testing and create an interference.  Once we have completed the initial evaluation to determine the best method that can potentially enumerate the most strains, we can move forward with product testing. If interferences or testing issues arise, then additional method development work may be required.
Probiotics are usually very high-count materials, and this can be a concern in a clean microbiology lab environment.  Precautions should be taken with lab design, sample segregation, extra cleaning and air handling to prevent possible cross-contamination with clean or bacteria-free samples housed in the lab.
It’s important to realize that not all labs are designed or are even able to perform these complex methods—choose your testing lab carefully. SORA Labs is highly experienced and can provide accurate testing for all your probiotic products. Make the obvious choice today!

Testing to ensure product and ingredient quality is a very important step in maintaining the integrity and efficacy of your brand.  Because of FDA and regulatory pressures, verification testing is always top of mind.  But testing also represents an investment in your product quality.  Have you ever considered how you can use testing result data to drive sales and build your company’s brand?
A non-modified Certificate of Analysis (CofA) from SORA Labs can be used in its entirety on your website or within your marketing material without any additional permission from us—it’s your purchase to utilize for this purpose.  If you do choose to modify the CofA or only use parts of it, we require a quick marketing agreement that allows us to approve the modifications.  We believe that your product testing investment is a quality-minded attribute that should be advertised and used to promote your brand.
Some ways to get the most out of your CofA can include highlighting testing results that demonstrate the quality of your ingredients or products.  If you show a CofA for aflatoxin, allergens, micro pathogens, or pesticide residue that are below the level of detection, this can instill customer confidence that your products are free from harmful substances and are safe to consume.  Showing results for botanical identity or active ingredient potency also lets consumers know they are getting the quality of ingredients they see on the label and have come to expect.  Additionally, tracking assays over time can be graphed/visually represented to show the ongoing shelf life and stability of your finished product.
SORA Labs wants to give you tools, such as solid testing data, to help you sell your products with confidence.  Product testing can give you much needed data and fact-based information to help set your products apart from the rest.  So, how can you use your CofA to create a more successful selling strategy? Use it to elevate your product quality in the minds of consumers and successfully build your brand!

The supplement industry tends to create complex, multi-ingredient blends in a complicated matrix. Developing a standard product matrix and validating methods therein, can be a time-consuming, costly process. Although the standard capsule or tablet form is most common, stick pack blended powders, liquids, gummies, soft chews and even supplemented food products have made their way into the market successfully.  But, have you ever thought about how standard methods were modified to accurately test these new products?  As dietary supplement sales continue to increase year over year, they will often out-pace science and method development. SORA Labs has the expertise and resources to successfully develop a testing process to fit your new product matrix.
Since the standard testing methods are often designed for single ingredient raw materials or simple finished products, these blended products are often challenging to test accurately.  Probiotics are a great example, as they are often included in complex, sugar and acidic flavored mixtures like gummies or soft chews. These samples can sometimes change the starting sample solution pH, and method development may be needed to determine if this pH variation will affect the method or if a pH adjustment needs to be considered before the testing begins.  When a method is modified, validation steps need to be completed to ensure the method still performs as designed.  Each step can be addressed and discussed to achieve the most accurate results for your matrix sample.
Enzyme blends in a sugar or soft chew type matrix, are another relevant example.  When performing a standard enzyme activity method, the first step is placing the sample into the solution, dissolving a gummy, sugary mixture can become perplexing.  Finding the best way to dissolve the matrix completely without destroying the enzyme itself, can also be a challenge.  Since enzymes deactivate with heat, warming the solution is not a valid option.  SORA Labs works with these sample types routinely, determining the optimum sample prep that allows the enzymes to act on the substrate and create the reaction needed to measure the activity, is key for a successful and accurate result.  Experience with difficult assays and complex matrixes is one of our specialties, and SORA Labs is here to help with method development and probiotic and enzyme blend testing! Call us today to take the headache out of this complex testing process.

To be labeled organic, foods and botanicals must be certified as such by the USDA. Since there are strict standards in place for growing and processing these ingredients, many fertilizers, insecticides, herbicides and fungicides in conventional farming are prohibited in organic production. This even includes pre-treated fungicides on seeds.¹  With so many restrictions in place for organic labeling, organic/non-toxic fungicides are being used, although sometimes proving ineffective in killing fungi. With this in mind, how can a manufacturer or brand mitigate their risk when purchasing and using ingredients that are labeled organic? The answer resides in testing.
Since organic/non-toxic fungicides are being used, it is imperative to ensure that these fungicides are actually effective in preventing mycotoxins formation.  Mycotoxins are secondary metabolites produced by microfungi that are capable of causing disease and illness.² Research shows that aflatoxin is the most common mycotoxin found in spices and herbs.³ Aflatoxins are produced from fungi that hasn’t been properly controlled. This leads to toxins being present in grains, nuts, herbs or other susceptible plants, calling for careful screening of aflatoxins when using botanical ingredients in products. Screening can be done with a general ELISA aflatoxin kit that measures total aflatoxin levels and gives an indication of toxins present in the material. There are also specific tests by HPLC or HPLC-MS technology which give exact levels of B1, B2, G1, G2 or other toxins.  Most often, general screening is completed on incoming botanical materials to see if aflatoxin is present, and then follow-up testing is ordered to determine the specific levels of each toxin.
Since organic fertilizers can introduce harmful bacteria to the foods or botanicals being grown, monitoring the bacteria contamination with stringent microbiology testing, is necessary.  Testing botanical ingredients for total plate count, coliform, Escherichia coli, yeast, mold and salmonella is a good place to start.  These counts will give you valuable information about the cleanliness of the organic herbal when it arrives at your facility.  Since microbiology contamination can happen anytime throughout the manufacturing process, additional microbiology testing needs to be completed before final release to the market.
Since the farming techniques for organics do not allow for commercial pesticides, run-off and contamination from other farms should be considered.  And while there are many other tests to consider for organic ingredients, screening for pesticide residue is a good idea to ensure contamination has not happened.
Botanical ingredients introduce a level of complexity not previously experienced when using other ingredients in nutritional products and working with those labeled organic, poses additional challenges.  Determining the needed testing can be complicated (Botanical Blog) but SORA Labs can help you determine the appropriate testing services needed for each ingredient. Don’t stress—let us help you with your testing needs today!
 
 

1. Guide for Organic Crop Producers, pg. 7.  ams.usda.gov/nop
2. Bennett, J. W., and M. Klich. “Mycotoxins.” Clinical Microbiology Reviews3 (2003): 497–516. PMC. Web. 31 July 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC164220/
3. The Scientific World Journal, Volume 2013 Article ID 874093.
   http://dx.doi.org/10.1155/2013/874093

Minerals are everywhere–they are in the soil, water, food and are even added to some supplements.  Since minerals are essential to a properly functioning body, an imbalance in our mineral levels may cause health concerns. Supplements are often formulated to contain essential minerals and are cleverly designed to improve health by adding vital nutrients back into the diet. Minerals may also be used to improve the supplement product itself. For instance, adding a mineral to an enzyme blend as a co-factor, enhances the enzyme reaction and improves how the product functions once ingested.
To follow Good Manufacturing Practices (GMP’s), manufacturers and brand owners must prove the label claims for the listed ingredients. Testing is the absolute key to verifying an ingredient’s identity and potency. For mineral testing, laboratories often use Ion Coupled Plasma (ICP) equipment, of which two main ICP units are utilized: ICP-OES (Optical Emission Spectroscopy) and ICP-MS (Mass Spectroscopy).
This technology can be confusing for customers, especially when a laboratory utilizes both ICP-OES and ICP-MS testing. Here’s the skinny—the ICP-MS is designed for very low detection limits such as trace elements and unwanted contaminants in products like heavy metals (Arsenic, Cadmium, Mercury and Lead), while the ICP-OES is designed to test higher concentrations of minerals which are listed in microgram or milligram quantities on the label. ICP-MS is also the clear choice when trying to comply with Prop 65 regulations and calculating heavy metals for your recommended daily allowance, as it is necessary to detect low residual levels in parts per million for these calculations.
SORA Labs offers dual functionality for all your heavy metal and mineral testing, as we have both ICP-OES and ICP-MS equipment. In addition, we can take the guesswork out of choosing which testing is best suited for your products—this is our expertise! Our team can assist you with verifying label claims or determining heavy metal levels in your products. Call us for more information today!

Botanical ingredients are a popular component of many nutritional supplement products. Since they are harvested at various times of the year from different regions of the world, the exact vitamin, mineral and nutritional potencies may vary from batch to batch. These factors contribute to the complex nature of these products and the difficulties involved in setting specifications for testing. Not commonly known, is that once several botanicals are blended together, the identity of individual botanicals is no longer possible—think of scrambled eggs. For these blends, active ingredient chemical marker testing is effective. And, if the botanical has a chemical marker, that marker could potentially be used to quantify or even just ensure it is actually an ingredient in the blend.
When testing botanical-containing products, using validated reference standards and “scientifically valid methods” is important to ensure accurate results. Recent news coverage and discussion in the scientific community have raised questions on how to prove the identity of botanical material and which method to use. While there are many methods including microscopic, wet chemistry, thin-layer chromatography, HPLC identification techniques, FTIR/NIR, DNA barcoding and many others, each botanical will have unique testing and even a combination of testing methods to prove its identity. Since no single method can ID every botanical, DNA Barcoding, FTIR and other technologies should be viewed as just tools in a lab’s tool box, not an all-inclusive solution. They are useful and excellent resources, but may not be the single or best way to identify botanical material.
Since botanicals are grown outside in the soil, they actually absorb moisture and nutrients from the soil and some of what is absorbed may be harmful. The presence of heavy metals (heavy metal testing) continues to make news and regulations, such as proposition 65, continue to evolve. Testing for Prop 65 levels is more than just determining the parts per million (ppm) residual amounts of heavy metals found in a product. Instead, Prop 65 takes exposure levels or the daily dose being taken, into account when setting limits. Once these levels have been determined in the product, a calculation should be done to measure the full daily amount that will be taken. This final calculation is the total amount that is reviewed for the CA Prop 65 limits.
Another little-known test is PPSL irradiation screening. (PPSL testing) Irradiation uses ionizing radiation to treat food ingredients for several reasons such as lowering microbial counts or destroying harmful microorganisms the botanicals have been exposed to in the environment. “The FDA has evaluated the safety of irradiated food for more than 30 years and has found the process to be safe. The World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) have also endorsed the safety of irradiated food.”¹ Even though the irradiation process is generally considered safe, there are certain labeling laws that must be followed. If an ingredient has been irradiated, a specific seal (see below) must be included on the product’s packaging. SORA Labs has identified irradiation among a variety of popular botanical ingredients including:  Barberry Root Bark, Barley Juice, Broccoli Powder, Cordyceps Ext., Cumin, Eyebright Powder Ext., Garlic, Gotu Kola Powder and Marshmallow Root Powder.  Although these represent some common occurrences, screening for all botanicals is recommended to ensure they are free from irradiation and are not mislabeled according to FDA regulations.
Other testing methods for botanicals include microbiology (rapid micro testing), pesticide residue (pesticide screen), residual solvent residue (residual solvents testing) and more. With so many factors to consider when testing botanicals, it is imperative to choose a testing lab that can help you navigate the complexities with ease. Contact us today for a quote on your ingredient testing!
 

 
 
 
 
 
References-

1. https://www.fda.gov/food/resourcesforyou/consumers/ucm261680.htm

Probiotic testing for potency to determine colony forming units (cfu/g ) is a complex process.  This month’s video features the steps involved in testing the high count bacteria in probiotics. This video begins with a sample that is ready to plate.  The preliminary stages in the sample preparation allow the freeze-dried bacteria to be re-hydrated and the spore forming bacteria to be heat-shocked for optimal growth on the agar plate. It’s important to know that each strain being requested to test for cfu/g count has specific method preparation instructions that are followed before the sample is ready for plating. Sample Request Form.
If the probiotics to be tested are single-strain, raw materials, then the ingredient vendor should be able to supply the correct test method.  If the sample is a blend of strains or is a combination of several manufacturers’ materials, then choosing the method can be more complicated, but not impossible.  An experienced lab will work to select a single method that allows several stains to grow out on the same media, although blended probiotics may take longer to complete due to the extra testing needed to determine the ideal method. Once the method has been determined, and testing is complete, the results of total cfu/g count can be used to substantiate the product label claims.
After determining the most appropriate method, calculating the dilutions to plate is the next step. If the product specification is 10 billion cfu/g, then the 10⁸ and 10⁹ serial dilutions would be plated to incubate. Ideally, it’s best to choose the dilutions that will allow for counting 25-250 colonies per plate when calculating results.  Plating is performed in triplicate to show repeatability and ensure consistent growth of the sample.  If no growth is seen on these plates, then it would need to be re-plated or be reported at <100 million cfu/g.  If re-plating is necessary, then the process is started over and the next two, or more, serial dilutions are plated. The method generally lists the incubation time, but most probiotics incubate for 72 hours. It is evident that sub-potent products or material without proper specifications often take longer and are costlier to test.
Choosing the correct test method and having accurate specifications is the key to having successful potency determinations for probiotic products. Specialty testing requires an experienced lab; with SORA Labs you can be confident that the results we provide your company have the best interest of delivering efficacious products in to the marketplace for you to be proud of.

Forsyth, MO—SORA Labs recently welcomed Quality Supervisor, David Gauwitz to their accomplished QC team. David brings nearly 35 years of proven, award-winning experience to further enhance the level of excellence that SORA is known for. As Quality Supervisor, David will be working on the continual improvement of ISO process management while supporting the lab to meet the highest quality standards.
Leading the quality team is Lab/Quality Manager, Bob Williams and Technical Manager, Ramona Clemens.  Ensuring accurate results takes continual verification of generated data. As the lab continues to grow, calibrations and data testing, along with “Out of Specification” investigations and analysis, become a larger undertaking to maintain the same high quality standards.  David will further enhance SORA’s ability to meet customer deadlines, along with ensuring every piece of the quality control process fits together.
Known for its consistently accurate and precise results, SORA Labs has a quality system in place that will withstand even the toughest scrutiny.  SORA Laboratories is registered with two different internationally recognized ISO standards: an ISO 9001:2008 certification and ISO 17025:2005 accreditation. These standards represent quality, accurate testing, designed to give customers peace of mind.
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For over 20 years, SORA Labs has been specializing in enzyme assays, probiotic testing, nutraceutical and agricultural testing methodology, along with being the foremost expert in testing for quality and potency in natural ingredients, raw materials and finished products.  SORA Labs has dedicated itself to perfecting methodologies, performing analytical tests and developing procedures to be a one-of-a-kind testing facility.  For more information, visit soralabs.com.