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30 Steps to the Birth of a FreeLife
Supplement
Product Development Phase
1. Concept - Earl Mindell's ongoing
research constantly reveals exciting new
nutritional ingredients and combinations.
2. Scientific Review - Earl Mindell
and his research team review the medical,
clinical, and scientific literature to verify
the safety and establish the ideal dosage for
each new nutrient.
3. Compatibility Study - Each new
supplement is designed to be taken safely with
every other FreeLife nutritional product.
4. Search for Ingredients - FreeLife
imports ingredients from 23 different countries
around the world.
5. Vendor Audit - Prospective raw
material suppliers are visited and inspected to
ensure their conformance with Good Manufacturing
Practices (GMP), equitable labor policies, and
environmental responsibility.
6. Raw Materials Specifications - All
incoming ingredients conform to pharmaceutical
standards of purity and effectiveness and meet
or exceed the strict Federal requirements of the
Dietary Supplement Health and Education Act (DSHEA).
7. Ingredient Testing Methods - Our
analytical laboratory works with scientists
around the world to develop unique and reliable
methods to guarantee the identity and potency of
the ingredients in every FreeLife supplement.
8. Master Formula - Each FreeLife
supplement is produced from a precise Master
Formula, which specifies ingredients, equipment,
detailed manufacturing instructions, and even
climate conditions.
9. Pilot-Scale Blend Study - Pilot
studies enable our scientists and technicians to
optimize each Master Formula. Pilot-scale
blenders are simply scaled-down models of
full-scale production equipment. A pilot batch
of ingredients is blended to determine the ideal
mixing time and conditions that will ensure a
uniform product.
10. Pilot-Scale Dosage-Form Study -
The pilot blend of ingredients is then converted
into the appropriate dosage form (tablet,
capsule, liquid, powder, etc.), so that strict
tolerances can be set in the Master Formula for
the finished product.
11. Approval for Full-Scale Production -
Upon passing an exhaustive battery of tests,
the Master Formula is approved and a requisition
is issued for full-scale production.
Production Phase
12. Receipt of Incoming Raw Materials -
No ingredient is received at our
manufacturing facility unless it is in properly
labeled packaging with tamper-evident seals. All
incoming shipments must be accompanied by full
documentation, including independent Certificate
of Laboratory Analysis.
13. Identification Screening of Raw
Materials - Our Quality Control inspectors
employ advanced n-IR (near infrared) scanning
probes, which send a high-intensity beam of
energy though the sealed containers. As no two
ingredients will absorb n-IR energy in the same
way, a unique fingerprint can be determined for
each ingredient.
14. Quarantine and Release of Raw
Materials - Once positively identified, all
incoming ingredients are segregated and
thoroughly lab-tested, including tests for
biological pathogens. Upon completion of
successful testing, the ingredients are released
for use in production.
15. Full-Scale Production - All
FreeLife products are produced under
climate-controlled conditions in FDA-inspected
facilities operating under Federal Good
Manufacturing Practices (GMPs).
16. Weighing and Blending - Following the
Master Formula, each ingredient is weighed,
tagged, and placed in a separate container from
each other ingredient. As each ingredient is
weighed, both the operator and supervisor must
sign off on the master batch record. This double
signoff is repeated again when each ingredient
is added to the blender. As a final step, the
tags from each ingredient are tallied to
eliminate any possibility of error.
17. Weight Variation Analysis -
In-process, tablets and capsules are
spot-weighed every ten minutes by quality
control technicians to certify that all products
are of uniform weight for consistent dosage.
18. Size Variation Analysis -
Pharmaceutical micrometer gauges verify that all
tablets and capsules conform to specifications.
These special gauges are accurate to 5/1000 of
an inch.
19. Tablet Coating - Finished tablets
are glazed with our proprietary VitaCoat™ for
ease in swallowing and to ensure freshness.
VitaCoat™ uses the antioxidant power of alpha-lipoic
acid to help protect the tablet against
oxidation and loss of potency.
Product Testing Phase
20. Potency Analysis - Potencies of
all FreeLife supplements are confirmed by
rigorous analysis, using sophisticated
laboratory equipment such as High Performance
Liquid Chromatography (HPLC), Fourier Transform
Infrared Spectroscopy (FT-IR),
Ultraviolet/Visible Light Spectrometry (UV/VIS),
and Inductively-Coupled Plasma Emission
Spectroscopy (ICP).
21. Content Uniformity Analysis - At
several points of the production run, samples
are taken and analyzed to make sure that they
contain the same levels of active ingredients.
22. Microbiological Analysis -
Ingredients and finished products alike are
tested to confirm the absence of harmful
bacteria, yeast, and mold. This attests to the
cleanliness and sanitation of plant, equipment,
and ingredients.
23. Tablet Hardness Analysis - Tablet
hardness analysis guarantees that the tablet
will not fall apart in normal shipping and
storage.
24. Friability Testing - Friability
testing ensures that the tablet will not fray at
the edges, which would cause loss of potency.
25. Disintegration Testing - FreeLife
guarantees that every tablet will disintegrate
under conditions found in the human body. We
confirm this by testing to strict governmental
USP standards.
26. Dissolution Testing - It is not
enough for tablets to disintegrate (fall apart).
They must also dissolve in order to be absorbed
and utilized by the body.
27. Packaging Materials Barrier Testing -
Bottles are specially designed to be
impervious to air and water vapor, which can
degrade delicate active ingredients.
28. Packaging - Bottles are filled on
modern, high-speed, fully-automated packaging
lines. Safety seals are affixed both inside and
outside each bottle.
29. Product Stability Testing - To
guarantee stability, all FreeLife products are
subjected to rigorous challenge testing. Random
production samples are placed in specially
designed chambers, where they are submitted to
temperatures of almost 100° F and relative
humidity of 75% for 12 weeks. They are then
subjected to an exhaustive battery of tests.
Total Quality Management
30. Total Quality Management -
FreeLife stands committed to continued
improvement of its quality products. To that
end, our manufacturing operation has instituted
an on-going system of GMP training and Standard
Operating Procedure review. Our Quality
Assurance program even calls for internal
audits, to make certain that we are living up to
the high standards written into our policy.


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1. |
Selection Criteria |
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Vine-ripened,
Himalayan-quality berries are carefully
harvested and sorted according to
FreeLife's® strict selection criteria. |
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2. |
Purification & Inspection |
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Berries are gently
washed at a licensed,
government-inspected juicing facility. |
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3. |
Juicing Process |
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Berries are juiced to a
puree by cold pressing through a
micro-fine screen to remove seeds and
stems. |
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4. |
Analysis & Testing |
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Goji puree is subjected
to complete nutrient and microbiological
analysis, and tested for absence of
pesticide residues. |
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5. |
Proprietary Chill-Blending |
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The puree is combined
with natural ingredients utilizing
FreeLife's® exclusive recipe and
proprietary chill-blending methods to
preserve the balance and content of the
active polysaccharides. |
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6. |
Cold-Fill Process |
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Himalayan Goji® Juice is
cold-filled into costly,
plasticizer-free pharmaceutical-grade
bottles. This provides superior
protection as compared to glass with no
possibility of 'leaching'. |
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7. |
Final Testing |
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Finished Himalayan Goji®
Juice is subjected to an exhaustive
battery of tests, including Spectral
Signature, polysaccharide analysis, and
full microbiological testing. |
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