
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 ephedra content in
ma huang 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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