Pure Encapsulations products quality control can be found HERE.
Standard operating procedures include sampling and testing incoming supplement ingredients, inspecting manufacturing processes, and testing finished products to specifications. Tests include organoleptic evaluation, physical testing of tablets and capsules, chemical identity of ingredients, potency and state-of-the-art analytical contamination testing, as well as microbiological testing by rapid analysis. Countless steps are taken to ensure the use of safe ingredients and those ingredients are followed through the manufacturing process to finished packaging with testing each step of the way for contaminants and imperfections.
Ensuring safety requires robust and rigorous manufacturing systems and processes. Some examples of the many systems and processes in place to ensure product safety include:
• The use of trusted, high quality raw material suppliers that likewise have systems and processes in place for safety and quality.
• All products and product ingredients are tested for adulterants and contaminants. This includes testing for heavy metals, microbiological contamination, cross contamination and for specific allergens and gluten. The water and air are monitored to insure there is no outside contamination coming in and equipment is tested to ensure that it is clean and sanitized.
• HACCP (Hazard Analysis Contamination Control Point) systems are used to identify potential hazards with barriers in place to prevent them from occurring.
• An Electronic MRP (Manufacturing Resource Planning) system is designed to ensure that the correct materials are used in production. Measures such as bar codes are used to double-check accuracy. Many other checks and balances are used in manufacturing such as separate quality control (QC) inspection processes. QC inspectors accept or reject raw materials, in-process materials, and finished products, based on meeting specifications. QC inspectors work independently from the manufacturing personnel to eliminate any potential conflict of interest.
In addition to Pure Encapsulations products being formulated under strict quality control and at safe ingredient levels, other less obvious factors are taken into account such as:
• Pure Encapsulations products do not use common mass market multivitamin excipients like hydrogenated oil, talc, Crospovidone, Butylated Hydroxytoluene, Chromic Chloride, Hypromellose, Nickelous Sulfate, Polysorbate 80, Sodium Metavanadate, Sodium Silicaluminate, Sorbic Acid, Triethyl Citrate, Glucose, Polyethylene Glycol, or Lactose Monohydrate. These excipients are designed to make manufacturing processes more efficient and less expensive, but products containing these synthetic excipients can no longer claim to be natural, which is one of the many reasons they are not used.
• Polysorbate 80 is a PEG derivative that is used in the formulas of many other companies to increase bioavailability. This petroleum-derived synthetic ingredient is not used in Pure Encapsulations products. Many enhanced delivery CoQ10 formulas contain Polysorbate 80. Pure Encapsulations CoQ10 does not contain Polysorbate 80.
• Chlorinated organic compounds are not found in nature. These compounds are toxic and very dangerous. PCBs and dioxin are examples. Sucralose is another example. Pure Encapsulations products are not formulated with chlorinated compounds.
• The fish oil supplement is molecularly distilled. This physical separation and purification process produces the best quality fish oil, free of harmful levels of heavy metal contaminants and pesticides. A common concern with fish oils is mercury content. The fish oil is mercury-free.
• CoQ10 is a particularly important antioxidant, however there are two forms: the naturally produced fermented trans-CoQ10 form and the synthetic, cheaper cis- form. The trans-CoQ10 is the form found in your body, while the cis-form is chemically different. Pure Encapsulations CoQ10 is the natural all-trans form of CoQ10.