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The VÄXA®
Top 1% Manufacturing Standard |
Since the
beginning of VÄXA in 1987, the strictest of product testing
procedures and quality control measures have been insisted
upon and instituted regarding the manufacturing of all VÄXA
products. VÄXA believes that good formulas can only lead to
good health by starting with quality and efficacious product
ingredients. Thus, VÄXA offers assurance that all of the ingredients
used in our formulations are simply the best available in
the world.
All VÄXA products, once manufactured and
packaged are then tested by lot to ensure quality control,
stability, consistency, weight, and content. Time series and
dating analysis are performed twice on all lots. First where
the materials were produced and later when received as finished
product by VÄXA. The strictest controls of inventory dating
and ongoing computer evaluations are performed daily while
total recheck of inventory are performed each month.
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Clinical Lab Conditions:
No Contamination |
The manufacturing lab
is a clinical environment with all stainless steel construction.
To clean the lab we utilize UV sterilization, carbon filtration,
reverse osmosis, ozone injection, mix bed de-ionization and
boiler kettle our own water. This procedure is above kosher
requirements. |
Precise Environmental Standards:
No Contamination |
Each room has
its own air handler that completely exchanges the air 50 times
per hour. Pure, clean air is a critical element in manufacturing
a pure product. There are so many contaminants in the air
that a state of the art air scrubbing system is a necessity.
Many facilities just have a dust handler and rely on the air
conditioning system to fight to replace the air. You might
as well make the product in the parking lot. The temperature
is at a constant 71 degrees and the humidity is less than
35%.
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Particle Sizing Means Greater
Absorbency:
Every Capsule Has the Same Ingredient Mix |
The key element of our
manufacturing process is particle sizing. Simply put, all
of the elements come in different particle sizes. Picture
BBs, ping-pong balls, golfballs, baseballs, softballs, and
basketballs. Improper mixing yields batches that have all
of the basketballs balls at the top and the BBs at the bottom.
This would mean that each capsule has a different mix of ingredients
(those early in the loading process - too many basketballs).
We use cold process pulverization to take all particles to
the same size - everything is a BB. Smaller particle size
means that the body assimilates the elements more readily. |
Blending Process Reduces
Oxidation:
Capsules Have Longer Lasting Potency |
The product is
weighed and blended in a static and gravity free environment.
This incorporates 100% batch involvement in the mixing process
with no dead spots. While in the blending process, the ambient
air has been removed and replaced with stable nitrogen, which
is heavier than air and reduces oxidation and process contamination.
The bulk material is weight validated to assure batch size
compliance, then formulation and quality control verified
for batch uniformity. The lab signs off on weight sheets to
make sure that everything that was supposed to go in went
in.
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| Capsules are Loaded One
at A Time |
In the encapsulation
department, pharmaceutical standard, GMP certified machines
employ the dose tamping method. Powder goes into the machine
then is tamped with pins into the capsule to the milligram
of accuracy. This process is done one capsule at a time. During
this process, at 5- minute intervals, a person will test to
validate quantities. The capsules are polished, dust is removed,
and they are hand inspected to see that they are not dented,
scratched, or broken. The finished product is analyzed using
high-pressure liquid chromatography, which creates a quantitative
analysis of a compound. Then a mass spectrometer is used to
create a qualitative analysis. This creates the blue print
that all future capsules must match. |
Every Capsule We Make is
Within a 1% Weight Tolerance:
No Short Cuts |
At the end of the production
process, checks are run to insure that the product weighs
what it should. Industry standards allow +/- 5% failure tolerances.
We insist on a tolerance of +/- 1%. Many manufacturers cut
corners here. It is in their interest to do so as 5% less
material in each capsule adds up to serious costs saved over
time. |
| Acceptable Contamination
Levels are 1/10th of Industry Standards |
Finally, a macro-biological
test is done to make sure that the lab did not contaminate
the product.
VÄXA's standards are 1,000% higher than what the industry
allows.
In the end, each
batch comes with a certificate of analysis and has a National
Drug Control number. Once it is manufactured and packaged,
the product is then tested by lot to ensure quality control,
stability, consistency, weight, and content. Time series
and dating analysis are performed twice on all lots, first
at the lab and then when received as a finished product
by VÄXA. Strict controls of inventory dating and ongoing
computer evaluations are performed daily, while total rechecks
of inventory are performed each month.
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