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Pure Encapsulations is committed to producing the most complete line of science-based nutritional supplements. Products contain absolutely no hidden fillers, coatings, artificial colors or other excipients that would disrupt or diminish the bioavailability of the ingredients. Additionally, formulas are free of wheat, gluten, preservatives and hydrogenated oils.

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.

Ingredient Quality

Our ingredients are selected solely on the basis of quality and purity and are provided in their most bioavailable forms. We source premium raw materials from trusted industry leaders, including the finest suppliers from the U.S., France, Japan, Switzerland, Germany and Italy. All ingredients are tested for purity and potency by independent certified laboratories. Ingredient suppliers must meet rigorous testing and quality criteria to qualify as a Pure Encapsulations supplier.

Manufacturing and Quality Control Excellence

We manufacture our own products in our own state-of-the-art plant in Sudbury, Massachusetts. All manufacturing takes place in temperature, humidity and dust-controlled rooms. Each piece of equipment is dismantled and sterilized before each production run. This includes scales, mills, blenders, powder fillers, encapsulating machines and capsule counters. Our warehouse is climate controlled in order to maximize the stability of our raw materials and finished products.

The manufacturing protocol at Pure Encapsulations is set forth in standard operating procedures (SOP's). Pure Encapsulations is NSF-GMP registered in the U.S., GMP certified in Canada and exceeds the standards of the United States Pharmacopeia (USP). 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.

All ingredients are quarantined upon receipt, pending independent certification of analysis. All ingredients undergo organoleptic and FT-NIR testing and are then bar coded and assigned a unique tracking number. Production batch records are inspected by a senior manager prior to blending and specialized software programs provide superior ingredient traceability. Finished capsules are tested for weight variation per USP and submitted for third party potency and contaminant analysis.

All production is performed in temperature, humidity and dust-controlled 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.

Finished Product Validation

Certified independent laboratories test raw materials and finished, encapsulated products. Using the most advanced equipment and test methods, including HPLC and GC-MS, these labs verify the potency and purity of ingredients. Independent microbiological testing is also performed to ensure supplement purity and safety.









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*These statements have not been evaluated by the Food & Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.
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