Quality Assurance: Issuing


Our production facilities feature a pharmaceutical grade bin system designed to help eliminate the possibility of direct and cross-contamination. The stainless steel bins reduce exposure and the need to transfer materials from one container to another, and they reduce the amount of handling our products experience. After use, each bin is cleaned in special bin-washing rooms. Using filtered water, we wash each bin with detergent and pure water rinses. Clean bins are then taken to a specially constructed drying room, which is heated to 140 degrees Fahrenheit. HEPA-filtered air eliminates the chance of contamination as the bins dry.

Bin charging, or mixing, begins in the Issuing Room where tested and approved raw materials are measured. Each ingredient passes through a conical mill, which ensures that any clumps are sifted into fine powder. The conical mills empty into a tube leading to a collection bin. Once all raw materials for a formula are loaded into the bin, it is weighed and compared to specifications to verify that the formula is complete. The bin is then sealed with an airtight lid to keep out dust or any other airborne particles as it is transported within the facility. This not only protects against foreign contamination, it prevents cross contamination from product to product and ensures our formulas are pure and clean from start to finish.

Sealed bins are then taken to the mixing room where they are attached to the bin hoist and mixer. The bin is raised and gently rolled by the mixer to create an even blend. Tooling in the lid of the bin helps to stir the materials as the bin is rolled. This method provides excellent mixing efficiency and preserves the integrity of individual granules.

Once a V3 product has been produced, each lot is statistically sampled and the finished product is audited by Quality Assurance inspectors for bulk weight, bottle count, bottle sealing and legible lot numbers. Samples are sent to the QA labs, so scientists can complete testing according to our finished product specifications. After all tests are completed, certificates of analyses are signed by QA. When a product successfully passes the finished product audit, QA will release it. The batch record and a sample of the finished product are then retained for future reference. If a customer has a question about their specific canister of ProArgi-9+, bottle of Mistify or bottle of PhytoLife , QA can refer to the retention sample of the lot in question.

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