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We
have built our business by producing the finest supplements possible.
Ingredient quality, manufacturing excellence and quality control are
our most important priorities. We differentiate ourselves by holding
our suppliers to the highest standards and by following strict near-pharmaceutical
manufacturing procedures. An industry first, we voluntarily submit all
of our encapsulated products to third party laboratories for HPLC validation
and provide our customers with the actual documentation in the form
of a CD. Pure Encapsulations remains unmatched in pioneering a rigorous,
validated quality control program.
Our
ingredients are selected solely on the basis of quality and purity and
are provided in their most potent and bioavailable forms. We purchase
premium raw materials from Japan, Switzerland, Germany, Italy, France,
and of course the U.S. Manufacturers of ingredients must pass rigorous
pharmaceutical grade analytical tests to qualify as Pure Encapsulations
suppliers.
Pure Encapsulations supplements are hypoallergenic. There are absolutely
no hidden fillers or coatings, binders, shellacs, artificial colors,
fragrance or excipients in our products that would disrupt or diminish
the bioavailability of any of our ingredients. Furthermore, our products
are free of wheat, yeast, gluten, corn, sugar, starch, preservatives
or hydrogenated oils.
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Manufacturing
and Quality Control Excellence
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We
manufacture our supplements in our own state-of-the-art facility in
Sudbury, Massachusetts.
The manufacturing protocol at Pure Encapsulations is set forth in standard
operating procedures (SOP's) developed in conjunction with ISSI Scientific,
Highland Park, NJ, a GMP and GLP consultant serving pharmaceutical companies.
Every step of Pure Encapsulations SOP's exceed the standards set forth
in the U.S. Pharmacopoeia and the NNFA GMP's. (We currently sell over
20% of our production as prescription items in Europe).
Our dedication to cleanliness is obvious from the moment our plant is
entered. A large staff is dedicated full-time to the task of ensuring
that our plant meets the highest standards.
The Quality Control/Assurance department is separate and distinct from
the Production Department, and has full authority to reject ingredients,
reject finished product and stop production, without the approval of
other company management. Pure Encapsulations QC/QA department is headed
by a Master of Science in Biology and Chemistry. The QC/QA team consists
of 5 full-time employees including 4 full-time inspectors in production.
All ingredients are quarantined upon receipt, pending independent certification
of analysis, usually by High Performance Liquid Chromatography (HPLC)
(unless another method is superior).
All ingredients are bar coded and assigned a unique tracking number.
Production batch records are QC'd by three senior managers prior to
blending, and specialized software programs provide a failsafe mechanism
to prevent misidentification of ingredients.
All production is performed in sealed humidity- and dust-controlled
individual rooms, supplied with Millipore filtered compressed air. All
production rooms are serviced by particulate remediation systems. Production
rooms are sanitized prior to the commencement of every capsule filling
run.
Encapsulation equipment is dismantled and sanitized prior to the commencement
of every capsule filling run. This includes scales, mills, blenders,
powder fillers, encapsulating machines, capsule counters and balances.
Our high tech equipment performs functions including capsule weight
checking, deformed capsule rejection and de-dusting.
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Finished
Product Validation
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Each
Pure Encapsulations lot is submitted to an independent laboratory for
final confirmation of potency and conformance with ingredient levels.
We are the only supplement manufacturer that has FDA certified laboratories
test every batch of finished, encapsulated products. This is an important
distinction from companies that use in-house laboratories, use skip-lot
testing or test ingredients prior to encapsulations or tableting.
Using the most advanced equipment and test methods including HPLC and
MS, these labs certify the potency of every ingredient against our label
claims. Each product has been verified to contain what it claims on
the label. These tests reflect the potency and purity of the actual
Pure Encapsulations supplements recommended by the health professional.
Furthermore, all results are provided in over 200 assays available to
all of our customers on CD, verifying our uncompromising standards.
All finished products must also pass the USP Microbial Limits Test.
Our finished products are tested by Integrated Biomolecule Corporation,
Vanguard Scientific, Eurofins Scientific and Advanced Food Micro.
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