1. Concept - Dr. Mindell's ongoing research constantly
reveals exciting new nutritional ingredients and combinations.
2. Scientific Review - Dr. 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.
