Quality

Standard Process has always taken great pride in its quality control program. Since the good manufacturing practices (GMPs) for dietary supplements were published in 2007, many companies began to look at quality in the way that we at Standard Process have been doing for decades.

Our team of scientists, composed of highly trained and degreed microbiologists and chemists, work meticulously to guarantee our customers receive the highest-quality products. Our quality control unit ensures our label claims are met and testing is performed after critical stages of production to confirm our products are free of bacterial contamination. Additionally, shelf-life studies are conducted on each product to make certain that label claims are met throughout the life of the product.

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Testing

Repeated testing on various stages of every batch throughout the manufacturing process enables us to ensure quality and safety of our products. On average, a batch is tested six times. Every week our scientists in our full-scale quality control laboratory perform as many as 1,100 tests on raw materials, in-process product batches, and finished product. We use analytical methods that have been approved by nationally recognized evaluative bodies, including the Association of Analytical Communities (AOAC) and United States Pharmacopeia (USP).

Gluten

In conjunction with the research and development team, the quality control department has internally validated a method approved by the Association of Analytical Communities for gluten testing using the RIDASCREEN (Gliadin) by Biopharm. The testing consists of an enzyme immunoassay to quantify the prolamins that are found in wheat, barley, and rye. In order for a product to be considered gluten free, it would need to contain less than 20 ppm of gluten, according to Codex Alimentarius international food standards. Products listed in this guide with the designation are tested for gluten each time they are manufactured to ensure gluten-free compliance.

Laboratory Information Management System (LIMS)

Standard Process’ quality control department has fully validated and implemented the Laboratory Integrated Management System (LIMS), Nexxis iLAB by Labtronics. The system allows for a centralized storage location for all data analysis conducted by the laboratory. This implementation has improved data analysis by ensuring quality and accuracy of results, providing real time data retrieval, preventing data errors, automating manual calculations and allowing for lab data to be accessed throughout the facility.

Chemistry

Standard Process chemists perform multiple assays to guarantee that our products meet or exceed label claims and to ensure the viability of the product through its “best used by” date. We use the following instrumentation in testing raw materials and final product mixes:

yellow-beaker.jpg High-Performance Liquid Chromatography (HPLC) Vitamins A, E, B6, B12, D, Niacin, Folic Acid
Gas Chromatography (GC Solvents
Inductively Coupled Plasma (ICP Minerals, Heavy Metals
High-Performance Thin-Layer Chromatography (HPTLC) Botanical Identification
Fourier Transformer Infrared Spectroscopy (FTIR Raw-Material Identification
LECO® Protein Analyzer

The chemistry laboratory personnel also conduct wet chemistry tests for a variety of things, such as vitamin C, vitamins B1 and B2, pepsin, bile salts, water activity, moisture, carotene, iodine, phosphorous, and chloride. The vast testing capability of the chemistry laboratory allows Standard Process to verify the identity, purity, and strength of our products and of the raw materials used in our products.

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Microbiology

Standard Process’ microbiologists perform pathogen testing on every product batch to ensure the products are safe to continue to the next stage of production. Testing is conducted on all facets of the manufacturing process, including raw materials, mixing, milling, tableting, capsuling, and packaging. Raw materials, in-process products, and final products are only released to the next stage of production by the quality control unit upon verification that the material or product has passed all testing requirements.

Tableting and Capsuling Process

Many tests are performed after the product is tableted or capsuled, including:

  • Tablets are monitored for size, weight, water activity, and hardness. Hardness testing ensures that tablets remain intact throughout the packaging and shipping process.
  • Capsules are monitored for size, weight, and water activity. Powders are monitored for water activity.
  • Weights of tablets and capsules are verified to guarantee that label claims are met.

Farm

Soil samples are taken annually to determine mineral and nutrient levels in the soil. No synthetic fertilizers or pesticides are ever used in the organic growing process.

Quality Checks from Raw Ingredient to Final Product

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Manufacturing Processes

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Dr. Royal Lee, founder of Standard Process, said, “Whole foods are the best natural source of vitamins. The key to the highest quality is the manufacturing process.” Because preserving the whole food complex is a top priority when manufacturing our supplements, we base our formulas on Dr. Lee’s time-proven philosophies. Our manufacturing process, from raw materials to finished product, takes an average of six weeks. Throughout the process, raw materials are handled in a carefully controlled environment and tested for quality.

Exclusive Manufacturing Processes

Each process is precision designed to preserve nutrients in raw materials.

Grinding

Immediately after harvest, whole foods grown on our certified organic farmland, such as Brussels sprouts, are ground for further processing.

Juice Extraction

To capture the nutrients from raw materials such as buckwheat, alfalfa, and pea vine, the juice is pressed from the plants and separated from the pulp. The result is a concentrated product containing both fat- and water-soluble nutrients.

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Separation Process

Selected animal tissues used to make our Protomorphogen™ and Cytosol™ extracts are ground to create a liquid slurry. The slurry is subjected to our proprietary multistep separation methods. All raw animal tissues are obtained exclusively from USDA-inspected facilities.

Low-Temperature, High-Vacuum Dryers

Raw materials are dried in low-temperature, high-vacuum dryers to preserve their nutrients.

Continuing the Process

We use isolated production suites for the following processes. These suites enhance cleanliness in the manufacturing area.

Mixing

Dried materials are measured and mixed with the utmost precision. Because of the variability in natural and organic ingredients, color, texture, and smell may vary from batch to batch. However, the basic formula remains constant, and quality is ensured by repeat testing.

Binding and Processing Aids

After mixing, our fluid bed granulator is used to add natural binding ingredients, such as honey and arabic gum, to the product batch for tableting.

Other processing aids we use include cellulose and calcium stearate. Cellulose is often used to give body to the powders. When needed, calcium stearate, derived from vegetable sources, is used to help product release from the tablet and capsule machines. No artificial flavoring is ever used.

Tableting, Capsuling, and Powders

Our supplements are offered in several forms of delivery. The three most common are tablets, capsules, and powders.

  • Tablets—The tablet presses used by Standard Process allow for high-volume production without sacrificing quality control in the manufacturing process. Currently, our tableting department produces more than 90 products.

    All of our finished tablets are routinely analyzed for content to ensure that label claims are accurate.

  • Capsules—Electronically controlled capsule machines are continuously monitored to ensure that precise amounts of product are measured and enclosed in gelatin and/or cellulose capsules. Capsules are packaged by weight, not volume. Therefore, the denser the product, the less you will find in the capsule. The gelatin capsules are considered pareve/parve, meaning the capsule has been processed so extensively that it can be considered to have been prepared without meat or other derivatives. The capsuling department produces more than 50 products.
  • Powders—In order to fill our powder formulas, Standard Process uses a volumetric filler. This system achieves very accurate fills and provides a highly consistent product from batch to batch.

Packaging

The majority of our products are sealed in amber glass bottles. The color of the glass helps protect the food’s nutrients from damaging light, while the sealed bottle helps prevent product oxidation. Induction seals and neckbands protect against product tampering. The bottled product is then labeled and packaged in ecofriendly cardboard boxes, providing easy storage, protection, and shipping.

Cleaning

In between product runs, all of the equipment used in our manufacturing process is taken apart, cleaned, and sanitized. Adenosine triphosphate (ATP) testing is used to validate the effectiveness of the equipment-cleaning process. In addition, the surrounding production suite, including the floors, walls, and vent covers, is cleaned.

Environmental Program

In order to monitor the general level of plant hygiene, Standard Process has implemented an environmental monitoring program for the facility. This program allows for detection of any microorganism that may be found in the facility, including the drains. The program is twofold. It highlights the presence of any foodborne pathogen that may be in the facility and determines the source of these pathogens. Routine meetings between production and quality control are held to maintain the highest level of cleanliness throughout all areas of the facility.