Quality Assurance

By testing for and counting the bacteria on machinery, equipment and personnel in the production area, we can evaluate the standard hygiene level and the efficiency of our cleaning procedures. By checking the bacteria counts in the production areas, we ensure that our products will not become contaminated in the manufacturing plant.

NSP utilizes two different methods to test for bacteria: swabbing methods and a device called a bactometer, which uses advanced computer technology to test for the presence of bacteria in raw materials, liquids and finished products.

The bactometer is the testing machine of choice. It detects the growth of organisms by the change of electronic signals passed through the testing modules containing suspect bacteria. An increase in conductance in the sample indicates growth of organisms, and changes in the electronic signals are used to count the amount of organisms present. Nature’s Sunshine was the first company in the industry to utilize this exciting technology.

Total Bacteria Testing

To use the bactometer to determine the number of microbes that might be contaminating a product, we take a total plate count. We test a sample of raw material or finished product and determine the amount of aerobic microbe contamination in the sample. We then compare this count to our stringent allowable spec levels. If any raw material counts are higher than allowable levels, the lot is rejected and returned to the vendor. Finished products are also audited to ensure they meet NSP quality specifications.

Mold and Yeast Testing

We regularly perform yeast and mold counts using the bactometer. Its special modules contain the elements a mold or yeast would need to sustain life if it were present. When the organism grows, it’s detected on the bactometer.

E. Coli Testing

The dangers of Escherichia coli (E. coli) bacteria are well-known. In large enough quantities, this bacteria can be fatal. NSP tests raw materials for the presence of E. coli using specially designed E. coli count plates that contain an indicator that turns the bacteria blue. This allows for visual identification of the bacteria and, of course, rejection of that particular lot of raw material.

Salmonella Testing

Salmonella bacteria is responsible for many food poisoning cases. NSP tests for salmonella bacteria in herb raw materials and products using what is called a 1-2 test. This test allows us to obtain results much more quickly than standard culture methods.

Organoleptic ID testing

This is usually the first step in the identification of herb samples coming into the Quality Assurance testing area. This analysis includes testing with the senses (checking the taste, odor, color and appearance of the raw herb material). Since herbs are natural products, their characteristics may vary. However, they must fall within a specified range.

Microscopy

A microscopic evaluation is performed on incoming herb samples to validate exactly which plant parts the sample contains (roots, leaves, fruit, bark), and to look for any foreign matter such as insect parts. This test involves the preparation of a slide of each herb powder. By analyzing the cell structure of the sample under the microscope, we can confirm the plant species and cell type (part of plant), and see possible contamination.

Thin Layer Chromatography (TLC)

TLC is a reliable analytical technique that allows us to identify herbs and measure their quality. Different components of an herb extract are separated from each other using adsorption and capillary action. An extract is spotted onto a plate, and the intensity of the spots represents the concentration of each component in the extract. Trained personnel can identify the components by color and identify colorless substances using a special detecting spray or ultraviolet light.

The TLC test allows us to “fingerprint” the herb sample and compare it to a library of known standards. By using the TLC test in combination with the FTIR test (below), NSP can be assured that the key components in a particular herb are present in the sample. NSP occasionally uses TLC to do comparison testing. We test NSP products against similar products made by competitors to ensure that the NSP products’ potency and purity are greater than that of our competitors’ products.

Infrared Spectroscopy (FTIR)

It's official name is Fourier Transform Infrared Spectroscopy. The FTIR herb test validates the authenticity and purity of an herb sample. A beam of infrared light is passed through a sample of the herb. As the beam shines on the sample, the sample absorbs energy from the beam at certain frequencies. If we chart the frequencies at which the sample absorbs energy, we get the absorption spectrum of the herb. No two herbs have the exact same absorption spectrum, so by comparing these charts to existing charts, we can positively identify the herb.

This test is critical because some herbs look, smell and taste exactly alike, but one may cost 25 times more than another. Without FTIR testing, there may be the temptation to dilute the more expensive herb material with inexpensive “fillers.” For example, golden seal plants have been over-harvested in recent years. As a result, the supply is limited and the raw herb is very expensive. Some may be tempted to dilute their golden seal with barberry, which has a similar chemical composition. The FTIR test makes it impossible to get away with this.

This test also measures the level of the key components in herb samples so we can maintain consistent levels of potency from one batch of product to the next.

Note the difference between absorption spectra from samples of golden seal and barberry:

Golden Seal	Barberry

High Performance Liquid Chromatography (HPLC)

This extremely sensitive, computerized tool allows us to analyze the ingredients in a mixture. We place a dissolved sample of a mixture in the autosampler unit and pump it through the analytical column. The mixture separates into different vitamin (or herb) components, and the highly sensitive detector measures the amount of each component in the mixture down to parts per million. By analyzing printed HPLC plots, we can verify proper ingredient ratios. We also use HPLC to examine the purity and potency of raw materials. For example, we use liquid chromatography to measure the parthenolide content in feverfew and the ephedra content in Chinese ephedra.

The figures below show plots for SynerPro® Multiple Vitamins & Minerals, and for Chinese Fen-Chi™.

SynerPro Multiple Vitamins & Minerals	Chinese Fen-Chi

Ash Test

We burn a small sample of herb material in a special microwave furnace for one hour at 700°C. This burns away all of the organic (plant) matter. Any ash that remains after the burn is mineral content or dirt, which is subsequently weighed.

Every herb has a characteristic mineral content and a corresponding typical ash content. If, in testing, we find an ash content that is significantly higher than the typical ash content, we suspect the presence of dirt or some other foreign inorganic material. Dirt is a common problem, especially with herbs harvested from plant roots. If harvesters do not take the time to completely clean the dirt from the roots, NSP rejects their herbs.

Acid Insoluble testing

The inorganic ash left after ash testing is treated with hydrochloric acid and burned again. Any remaining ash is called acid-insoluble ash (AIA). A high AIA value may indicate that the herb sample is contaminated with metal particles.

Gamma Counter

Some raw materials that come from eastern Europe may be contaminated with radiation from the Chernobyl nuclear power plant disaster. The Gamma Counter will show us if the materials are contaminated and will help us keep our products free from radiation.

Gas Chromatography/Mass Spectrometry (GC/MS)

By using gas chromatography, we can separate complex mixtures of compounds into individual components. A sample of a mixture is placed in the GC machine where it’s heated and becomes a gas. As this gas travels through a tube in the machine, the individual elements in the mixture separate and attach to a special coating in the tube. These separated elements enter a detection unit called a mass spectrometer, which graphs individual elements and allows us to identify the compound.

By examining these graphs we can look for unwanted elements such as pesticides. This use of leading technology gives Nature’s Sunshine Products the advantage in ensuring the quality and purity of our natural health products.

The graph shows the elements in a sample of peppermint oil.

Nature's Sunshine meticulously tests all the raw materials we receive. Our quality assurance testing continues throughout the entire production process. In all, we use more than 150 tests and procedures to ensure the quality of the raw materials we use and the finished products we well. The following list represents a few of the most important tests we conduct.

Acid Insoluble testing Ash testing Bacteria testing E. coli testing Foreign Organic/Inorganic Matter Gas Chromatography/Mass Spectrometry (GC/MS) Heavy Metals testing High Performance Liquid Chromatography (HPLC) Inductively Coupled Plasma Spectrometer (ICP) Infrared Spectroscopy (FTIR)

Microscopy Moisture testing Mold and Yeast testing Organoleptic ID testing Particle Size pH testing Potency testing Salmonella testing Tablet Disintegration/Dissolution Thin Layer Chromatography (TLC) Total Bacteria testing Viscosity testing Volatile Oil

Every test we conduct leads to better product quality, and excellence in product quality is what has put our products where they are today--at the top of the industry. You can be assured that with each new product we develop and manufacture, our commitment to excellence will continue.