Testing Methods

These are just some of the tests performed by Nature's Sunshine

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.

Anaerobic Testing

Acidophilus and Bifidophilus are families of bacteria that positively influence digestion and proper intestinal function. These bacteria live and reproduce without air (anaerobic). NSP products that contain these organisms have extremely high counts (millions of organisms per capsule).

NSP uses special testing equipment and analytical procedures to quantify anaerobic organisms. NSP is one of a handful of nutritional supplement companies in the U.S. that has the ability to test for Acidophilus of Bifidobacterium. The standard test requires six complex steps to be completed and takes three days for the final analysis. The NSP staff has developed a new procedure using the Bactometer (see Microbiological Testing below) that can determine anaerobic test results within a 24 hour period.

Ash Testing

Nature's Sunshine burns 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, they find an ash content that is significantly higher than the typical ash content, they 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.

Disintegration Testing (tablet)

Each lot of tablets or capsules produced at Nature's Sunshine must pass the test for disintegration. Tablets and capsules are tested in accordance with the United States Pharmacopoeia. The tablets or capsules are placed in water maintained at 37° C, and the motion of the disintegration apparatus simulates the passage of a tablet or capsule through the body. The time required for each tablet and capsule to break down is recorded, and all tablets and capsules must dissolve within 30 minutes to be accepted by Nature's Sunshine Quality Assurance.

Dissolution Testing

This test mimics the body’s digestive system and shows the amount of product that is available for use by the body over time. Nature's Sunshine uses this equipment to test their time-release products such as T/R Vitamin C, T/R Valerian and T/R St. John’s Wort. The Dissolution System controls critical environmental parameters for the sample being tested, including temperature, stir rate, sampling time and sampling volume. This close control allows for the highest possible accuracy in testing of their time-release products.

Collected samples are analyzed using extremely sensitive analytical instrumentation such as HPLC or UV-Vis analysis. These instruments show the rate at which the compound is released.

E. coli Testing

The dangers of Escherichia coli (E. coli) bacteria are well-known. In large enough quantities, these 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.

Environmental Monitoring

Nature's Sunshine uses two techniques to evaluate the effectiveness of their cleaning procedures. First, they use microbiological swabbing to determine if any organisms are present on a piece of equipment. Through serial dilutions and the plate count method, they can determine the number of organisms present.

Second, Nature's Sunshine utilizes a new instrument that measures Adenosine-triphosphate, or ATP - the energy building blocks in every cell. This instrument (called a bioluminometer) can detect product and sanitizer residue by measuring bioluminescence (emission of light) of any ATP present on the surface of the equipment. The combination of these two techniques ensures that all cleansing procedures meet strict sanitation standards.

Finished Product Auditing

Once a product has been produced, each lot is statistically sampled, and the finished product is audited by Quality Assurance inspectors for bulk weight, liquid volume, bottle count, bottle sealing and legible lot number. Samples are then given to QA labs so scientists can complete testing according to finished product specifications.

After all tests are completed, certificates of analysis are signed by Quality Assurance. The batch record of the product is reviewed to ensure the product was produced by Good Manufacturing Practices. When the product successfully passes the finished product audit, Quality Assurance will release the product. The batch record and a sample of the finished product are retained for future reference. If a customer has a question about a product, QA can refer to the retention sample of the lot in question.

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 NSP if the materials are contaminated and will help them keep their products free from radiation.

Gas Chromatography/Mass Spectrometry (GC/MS)

By using gas chromatography, NSP 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 NSP to identify the compound.

By examining these graphs NSP 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.

Inductively Coupled Plasma Spectrometer (ICP)

The ICP has a flame that burns at 8,727°C. NSP dissolves a sample of raw material or finished product in acid and then spray the solution in to the middle of the flame. Inside the flame the different elements glow with their own unique colors. For example, calcium will glow with a different color than potassium. A highly sensitive spectrophotometer measures the brightness of each mineral in the flame and the graph tells them how much of each mineral is present in the sample down to parts per million. If there are any unwanted elements in a test of raw materials, the shipment is rejected.

This testing device screens raw mineral samples for unwanted elements like arsenic, lead, cadmium and mercury. The ICP is also used to test finished products like Super Supplemental Vitamins & Minerals™ and Mega-Chel® to ensure their mineral content meets label claims.

High Performance Liquid Chromatography (HPLC)

This extremely sensitive, computerized tool allows Nature's Sunshine to analyze the ingredients in a mixture. They 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, NSP can verify proper ingredient ratios.

Nature's Sunshine also uses HPLC to examine the purity and potency of raw materials. For example, they use liquid chromatography to measure the parthenolide content in feverfew.

Infrared Spectroscopy (FTIR)

Its 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 you chart the frequencies at which the sample absorbs energy, you get the absorption spectrum of the herb. No two herbs have the exact same absorption spectrum, so by comparing these charts to existing charts, NSP 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 NSP can maintain consistent levels of potency from one batch of product to the next.

Microbiological Testing

Nature's Sunshine ensures the quality and purity of their products by utilizing an instrument called a Bactometer. 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. An increase in conductivity in the sample indicates growth of organisms, and the time at which the increase occurs determines the amount of organisms present. All raw materials, in-process samples and finished goods are subject to testing on the Bactometer to verify they meet NSP's stringent microbiological standards. Nature's Sunshine was the first company in the nutritional supplement industry to utilize this exciting, new technology.

By testing for and counting the bacteria on machinery, equipment and personnel in the production area, they can evaluate the standard hygiene level and the efficiency of their cleaning procedures. By checking the bacteria counts in the production areas, they ensure that their 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. In addition to the tests mentioned below, tests are also conducted for the presence of coliforms, pseudomonas and Staphylococcus aureus bacteria.

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, they can confirm the plant species and cell type (part of plant), and see possible contamination.

Mold and Yeast Testing

Nature's Sunshine regularly performs 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 is detected on the bactometer.

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.

Salmonella Testing

Salmonella bacteria are 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 them to obtain results much more quickly than standard culture methods.

Thin Layer Chromatography (TLC)

TLC is a reliable analytical technique that allows NSP 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.

Total Bacteria Testing

To use the bactometer to determine the number of microbes that might be present, Nature's Sunshine takes a total plate count. They test a sample of raw material and determine the amount of aerobic microbe contamination in the sample. Then they compare this count to their 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 that they meet NSP quality specifications.