CAPABILITIES • QUALITY ASSURANCE
Nutritional Supplement Quality Control
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.
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.
Pure Encapsulations supplements are hypo-allergenic. All two-piece capsules are hypo-allergenic and vegetarian. There are absolutely no added coatings, binders, shellacs, artificial flavors, artificial sweeteners or colors, fragrance or excipients in our products that would disrupt or diminish the bioavailability of any of our ingredients. We do not use magnesium stearate in any of our formulas. Our products also do not contain wheat, gluten, nuts, egg, preservatives or hydrogenated oils. Furthermore, we have a comprehensive allergen SOP in place to prevent ingredient cross-contamination.
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. Our high tech equipment performs functions including capsule weight checking, deformed capsule rejection and de-dusting.
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.