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Introduction
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.

Ingredient Quality
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.



Manufacturing and Quality Control Excellence
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. 



Finished Product Validation
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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