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Raising the Quality Standard and Rising Above the Rest
Is a dietary supplement just a dietary supplement? It can easily appear
that way, especially with thousands of different brands of dietary supplements on the
market today. Pharmacies, supermarkets and other retail outlets are setting up in-house
"supplement stores" and virtually every highly circulated print publication and
news program is touting the benefits of nutritional supplementation. Propelling the
explosion of health awareness and the ongoing quest for "anti-aging", hundreds
of studies are emerging about the benefits of nutrient supplementation. Some of these tell
us what we have known for years (it is believed that the ancient Egyptians recognized a
nutrient, vitamin A, that can prevent night blindness).
Today, taking nutritional supplements has become so commonly accepted
as a way of improving health and preventing the effects of aging that it is not surprising
that the vitamin business has become a $40 billion dollar a year global industry.
So the
question is no longer Do nutritional supplements work?,
but rather How can I
tell one product from the next?
The answer is one simple word that may be difficult to
define--QUALITY.
Great lengths are taken to ensure that
every supplement leaving the laboratory is the highest quality available. The quality
starts with a team of PhDs that specialize in Pharmaceutics and Nutrition. Rigorous
quality control standards have been set and are adhered to throughout every step of the
manufacturing process. Our manufacturing and packaging facilities occupy more than
150,000 square feet of ISO 9001 certified world-class
manufacturing, there are three in-house ISO 17025 accredited laboratories –
Chemical Analysis Laboratory, Physical Analysis Laboratory, and Microbiology
Laboratory.
The facility is regularly inspected by state,
FDA and international regulatory agencies.
State of the art equipment and technology
yielding high volumes of product 24 hours a day 7 days a week.
This includes high speed
tablet presses that can produce more than 10 million tablets daily, encapsulating machines
that output more than 600,000 capsules every hour and complete turnkey packaging that
includes bottling with tamper proof induction sealing and daily convenience packs. In
house testing laboratories include Microbiology, Physical Properties Testing and
Analytical Analysis, including HPLC (high performance liquid chromatography), UV/VIS
(ultraviolet/visible), spectrophotometry and ICP (inducted coupled plasma testing).
The Raw Materials
Raw materials come from all over the world. The vendors used are the
most reputable in the industry. When possible, USP, FCC (Food Chemical Codex), NF
(National Formulary) and pharmaceutical grade are used. Once sourced, only the best
available materials that are accompanied by certificates of analysis (COA) are received
into the facility. The "vendor-supplied COA", however, does not suffice for
passing the material through to formulation and manufacturing. Each and every raw material
is quarantined until it passes a battery of tests including in-house microbial testing,
which conforms to USP XXVIII specifications. This includes a series of microbial testing
procedures which make certain that the material is within USP specifications for yeast,
mold, and free of E.coli, salmonella, and other contaminants that may be present in raw
materials. It is also important in selected materials to test for heavy metals (such as
lead and aresenic) contamination. In addition to these rigorous test conducted on-site,
often raw material is sent for independent testing and verification to an outside
laboratory.
The Manufacturing Process
We use a cold process manufacturing technique. This method promotes
content uniformity and potency within each batch of product. It is the preferred technique
of manufacture over wet granulation, which exposes the material to heat and moisture. Cold
process assures and protects the physio-chemical integrity of the nutrients. In addition
to written SOPs (Standard Operating Procedures) that comply with nGMPs (nutritional Good
Manufacturing Practices) in all steps of manufacturing, there is a quality control
cross-checking procedure that is implemented throughout the entire process. This way, more
than one person checks the accuracy of each phase throughout the course of production. For
every product lot number, retained samples are taken from each batch. Frequently the
product is tested for active constituents, and analysis is conducted to make sure that it
meets label claim throughout the product's shelf life. In-process quality control teams
constantly monitor quality and provide on-site training around the clock. There are no preservatives, corn, wheat, starch, yeast or artificial
additives added to the product. Also, tablets are coated without using artificial waxes,
colors, or sugar coatings.
In-House Testing Method for Quality Assurance
Our products meets and exceeds USP/NF (United Stated
Pharmacopea/National Formulary) specifications where applicable. The USP XXVIII is
recognized as the authority for guidelines of vitamins, minerals, and pharmaceuticals. It
outlines the standards of identity, strength, quality, purity, packaging and lableing. For
instance, the USP specifications for disintegration of coated tablets states that it must
not exceed 45 minutes in water at 37 degrees Celsius. Our Optimum Health
Essentials tablets, for
example, disintegrate at approximately 30 minutes. This information is provided on
Certificates of Analysis, which are available.
HPLC, or High Performance Liquid Chromatography, is a very specific
method of analysis that is accepted as one of the best ways to quantitate the amounts of
vitamins and other compounds in the product. HPLC may be coupled with UV (ultra violet)
testing. UV testing may also be done alone. ICP, or Inducted Coupled Plasma, testing is
used to quantify the mineral contents. Highly trained laboratory technicians and quality
control experts conduct all of this analysis.
The Finished Product
Once produced, each and every capsule and tablet undergoes a visual
inspection process to ensure that they are free from any physical defects. And again,
microbial testing is performed on finished product to verify that USP XXVIII microbial
limits for nutritional supplements are met. To protect the integrity of the product,
unbreakable high density polyethylene (HDPE) bottles are used to guard against light and
excessive exposure to heat and moisture. These bottles meet USP XXVIII specifications and
are made from a widely and easily recycled material.
The HDPE bottles are more environmentally friendly than glass, which
requires a large amount of fossil fuels for recycling that contribute to polluting the
environment. Tamper proof safety seals are put on each bottle and double-checked before
the lid goes on and the product moves to the next phase.
The last step of the process is the step that the consumer sees
first-the label. Either pressure sensitive or hot glue labels are adhered to the bottles.
Our labeled product has the Supplement Facts format and is compliant with the Dietary
Supplement Health and Education Act guidelines for consumer friendly labeling. (See How to
Read a Supplement Facts Label).
Full Compliance with Public Health Security and Bioterrorism Preparedness and
Response Act of 2002,
assuring safety and uninterrupted flow of all raw materials.

The new, sophisticated custom computerized software program that is
fully integrated controls all of the processes and is compliant with the
Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These
efficient programs feature every aspect of the processes including electronic order entry,
electronic monitoring of product processes from raw material purchasing to scheduling, and
finished product inventory. With this precise system, the laboratory is able to make
batches that are produced based on predicted demand size. This keeps excess inventory from
sitting on the shelves and provides the consumer with the freshest product available.
Stored in tightly controlled conditions of temperature, humidity and
light, the nutritional supplements manufactured are not stored for more than 3 months. The
entire 150,000 square feet facility is air conditioned and temperature and humidity
controlled 24 hours a day, 7 days a week.
Quarterly inventory maintenance is conducted to
assure freshness.
Most of our time sensitive formulas are only one week old when they are
shipped.
The longer shelf life products are no more than three months old when shipped.
Often after 3 months, excess product may be used for relief donations.
A few recent
donations from the manufacturing facility include orphanages in Haiti, the Baltic Islands,
and Calcutta, India.
How to read our Nutritional Label
Our Certificate of Analysis Document
Governor Bush's Response To Senate Bill 1525
What Our Customers Have to Say
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Nutrition Dynamics, Inc. 510 West Court Street Seguin, Texas 78155
800.926.2906
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