Disintegration
Each lot of tablets or capsules produced at NSP 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 NSP 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. We use
this equipment to test our 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 our 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.
Ash testing
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.
High Performance Liquid Chromatography
(HPLC)
This extremely sensitive computerized instrumentation
allows us to analyze the ingredients of a mixture. The instrument uses advanced
analytical techniques to separate, identify and quantify individual components.
Vitamins and active constituents in herbs are tested on the HPLC. These
components are measured in all finished products to verify that each lot meets
the amount claimed on the label. We also use HPLC to examine the purity and
potency of raw materials, particularly herbs that have active compounds. For
example, the parthenolide content in feverfew and the capsaicin content in
capsicum must meet specifications before these materials can receive QA
approval.
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.
Microbiological testing
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. In addition to the tests mentioned below,
tests are also conducted for the presence of coliforms, pseudomonas and
Staphylococcus aureus bacteria.
Total Bacteria testing
To use the bactometer to determine the number of microbes
that might be present, we take a total plate count. We test a sample of raw
material 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 that
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 is detected on
the bactometer.
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.
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 us to obtain results
much more quickly than standard culture methods.
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