Hi ARIIX Family!
It’s time for our March Quality Message!
First off, we’d like to introduce you to our newest member of the ARIIX quality team, Jason Child, our Quality Inspector. Jason comes to ARIIX with 21 years of manufacturing and quality assurance experience across several industries, including dietary supplements, aircraft and automotive components and custom window blinds. We’re excited to have Jason join our team and use his skills to ensure that you continue to receive only the best quality products!
Jason Child, ARIIX Quality Inspector
Product Testing: Part 1
Today we’d like to share insight into a frequently asked question regarding quality testing, specifically:
“How many times does a product get tested before it gets to me?”
Before we answer this question, let’s first explore what “product testing” actually means:
Product testing, as required by the US Food and Drug Administration (FDA) includes testing for four major criteria. These criteria are Identity, Purity, Composition, and Strength.
- Identity is the verification through testing that the material is what the vendor says that it is (e.g., that the powder being sold as ‘pea protein’ is, in fact, ‘pea protein’ powder).
- Purity is the verification through testing that the material is free from harmful substances, such as heavy metals, pesticides, and harmful microorganisms (e.g., coli, Salmonella, or Staphylococcus aureus).
- Composition is the verification through testing that the material is made up of what it is supposed to be (e.g., powder labeled as pea protein does, in fact, contain protein)
- Strength is the verification through testing that the material meets the potency listed on the label (e.g., pea protein labeled as 90% protein is at least 90% protein).
Before each ingredient is shipped to our product manufacturers, the ingredient manufacturer must test it to ensure that it meets the established specifications for each of the four testing criteria.
Once the ingredient has passed testing by the ingredient manufacturer it is shipped to our manufacturer. Upon arrival, the incoming ingredients are inspected to make sure:
-there are no physical defects (such as damage).
-that the material is labeled appropriately.
-the ingredient appears correct in terms of color, texture, particle size, aroma, and flavor, as applicable.
Once this inspection is completed, samples of each ingredient are collected and taken to the laboratory for additional testing.
Ingredient testing at the manufacturer is performed to confirm the ingredient manufacturer’s testing (as reported on the Certificate of Analysis);
After the ingredients have completed testing with favorable results, they are used to manufacture the finished product (more on this process in a future Quality Message).
Once the products are manufactured, they must also be inspected and tested to ensure that they meet established specifications for Identity, Purity, Composition, and Strength prior to being shipped to ARIIX.
In addition to our manufacturers’ testing of products, we also enlist the help of professional laboratories to test products if we feel additional testing would be beneficial.
Product Testing: Part 2
Product testing is performed using a variety of instruments and traditional chemistry and microbiological techniques. Photos below courtesy of ARIIX Manufacturer and Contract Laboratories.
Traditional microbiological testing involves the use of culture tubes, petri plates and culture media. Tests are performed using different culture media, which promote or prevent the growth of the microorganisms in question. For example, in standard testing for Staphylococcus aureus, media containing certain sugar metabolized by Staphylococcus, along with elevated levels of salt, which prevent the growth of other types of bacteria, and a chemical which changes color in the presence of acid (which is produced as the bacteria metabolize the sugars) are used to indicate the presence of S. aureus in a sample.
Petri plates containing microbiological culture media:
A microbiologist preparing samples by adding dissolved product to Petri plates:
These traditional microbiological tests can take several days, as they rely on the growth of microorganisms into colonies which can be counted visually, which is quite slow. In recent years, instruments which speed up these tests have become more common. These instruments operate on a similar principle – promoting or preventing the growth of microorganisms by culture media – but use special receptacles for the samples and media and sensitive detectors which can measure changes within the culture to calculate the quantity of microorganisms present.
Sample receptacle cards for rapid testing:
Rapid Test Reader instrument:
Microbiological analysis seeks to answer two questions: (1) “what kind of microorganisms are present in a sample?” and (2) “how many microorganisms are present in that sample?” Typical microbiological tests include some generic tests, such as:
- Total Plate Count – a measurement of the total bacterial count in a sample
- Total Yeast & Mold – a measurement of the total fungal count in a sample
- Total coliforms – a measurement of the total count of bacteria of a family to which several pathogens belong
and specific test, including targeted screens for pathogenic bacteria:
- Presence of Salmonella
- Presence of Staphylococcus aureus
- Presence of coli.
ARIIX maintains strict specifications for our products to ensure that they are free from harmful microorganisms.
One method for establishing the Identity of herbal ingredients is through Microscopic Analysis. This method requires extensive training and some sophisticated microscope equipment but is very useful in verifying the identity of herbal ingredients used in ARIIX products. Our manufacturer is one of the few laboratories in the USA which uses this method and is recognized as an expert in this field by many in the industry.
Microscopic Analysis equipment:
Product Testing: Part 3
Traditional chemical tests are often called “wet chemistry,” or “benchtop tests,” and often involve using solutions of different chemicals to test products. Common traditional tests include pH (a measure of the acidity of a sample), Titration (adding a chemical to a sample until a color change reaction occurs to measure the quantity of a constituent of the sample, such as vitamin C), Loss on Drying/Moisture Content (measuring the amount of moisture in a sample), Thin Layer Chromatography (measuring a chemical “fingerprint” of a sample to verify Identity) and disintegration time (measuring the amount of time a capsule takes to break down in the stomach).
A Thin Layer Chromatography (TLC) plate showing an example of a TLC chemical “fingerprint”:
In the last few decades, the use of laboratory instruments to perform chemical analysis has greatly expanded our ability to test materials. Our laboratories (both suppliers’ laboratories and professional contract laboratories) utilize the following instruments:
- Infrared (IR) spectrometer – measures a “chemical fingerprint” which can be used to verify the Identity of a sample.
- Spectrophotometer – measures the absorbance of light at different wavelengths; can be used to determine the quantity of vitamins or other compounds within a sample.
- High Performance Liquid Chromatography (HPLC) – very sensitive instrument that separates compounds within a sample dissolved in liquid and measures the quantity of desired compounds to verify Strength specifications (e.g, verifying the level of vitamins in a sample). Quantities are measured in the parts per million range.
- Gas Chromatograph – Mass Spectrometer (GC-MS) – Extremely sensitive instrument which operates similar to HPLC, but uses gas instead of liquid. More than one million times more sensitive than HPLC. Useful for measuring Purity of a sample (such as in verifying that a sample is free from pesticides or other undesired chemicals).
- Inductively-Coupled Plasma – Mass Spectrometer (ICP-MS) – measures minerals and metals within a sample. Similar sensitivity to that of GC-MS; useful for measuring the Composition (e.g., verifying the quantity of desired minerals in a sample) and Purity (e.g., verifying that a sample does not contain heavy metals) of a sample.
Inductively-Coupled Plasma – Mass Spectrometer (ICP-MS) Instrument:
High Performance Liquid Chromatography (HPLC) Instrument:
So the short answer to the question asked in Part 1 is: An ingredient is tested a minimum of twice before it is used in product manufacturing. In all, it is tested a minimum of three or four times, with many tests at each round before it is released and approved to be shipped to you!
We take pride in our ARIIX Gold Standard. All of our standards and procedures regarding our products are built around this commitment. The ARIIX Gold Seal of Approval symbolizes our relentless pursuit of excellence and innovation in the health and wellness industry.
We hope this information brings you insight and understanding on how we accomplish our ARIIX Gold Standard.