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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