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Simplexity Health's Quality Assurance Program

Simplexity Health's Quality Assurance program is comprehensive and is designed to ensure high-quality finished products. The program involves not only every phase of providing our organic microalgae to customers, but also the testing and review of components and ingredients from any of our suppliers. We trust that this review of our Quality Assurance program will help each customer have an even greater level of confidence in the quality of products purchased from Simplexity.

Quality Assurance for Harvesting and Processing
Aphanizomenon flos-aquae from Upper Klamath Lake

Pre-harvest scouting involves collecting algae samples from potential harvest locations. Samples are taken for testing to our in-house laboratory or to a field laboratory on the Lake harvester.

Pre-harvest tests include microscopic analysis to determine the species of algae present, biomass evaluation to determine the amount of algae present, and purity testing of the algae.

When conditions are optimal, we begin harvesting.

Post-harvest analysis involves microscopic in-house testing to verify the purity of each batch that is harvested and to ensure that we meet state guidelines. Chlorophyll testing, as well as other pigment testing, further ascertains the quality of the algae.

Post-harvest independent testing is also crucial. Each harvest season we send samples of each batch of algae to world-renowned algae scientists Dr. Don Anderson of Woods Hole Oceanographic Institute and Dr. Wayne Carmichael of Wright State University for independent testing. This independent testing serves as our official test results.

Low-Temperature Spray Drying

Once we receive test results back from the independent laboratories, we can begin drying the algae. We use a low temperature spray-drying process called BioActive Dehydration™. A proprietary Oxy-Guard™ system prevents oxidation during drying. This is extremely important because oxidation degrades algae. Before changing to this drying method several years ago, we performed numerous tests, which showed that chlorophyll and enzyme levels were excellent for the BioActive Dehydration spray-dried algae. Our drying process also meets the stringent guidelines for both organic certification and kosher certification.

SBGA Powder Analyses by Independent Laboratories

After drying, each batch of algae goes through yet another round of testing by independent laboratories.

  1. Dr. Don Anderson's lab analyzes the powder for chlorophyll and other pigments.
  2. A certified food lab tests for:
    1. Microbial levels (aerobic bacteria, coliforms, Escherichia coli, yeasts, molds, Salmonella, Listeria, Shigella, Staphylococcus).
    2. Metals (arsenic, mercury, cadmium, selenium, chromium, lead).
    3. Pesticides (organophosphates, organochlorides, carbamates).

Certificate of Analysis

After a batch of algae has passed all quality assurance testing, a Certificate of Analysis is issued for that batch, releasing it for use in the production of dietary supplements and foods.


Quality Assurance for Finished Products from Vendors


Shipments of finished products are placed in quarantine before being inspected and sampled by our Quality Control department. Review of the product includes the following:

  1. Inspection of the bottle, the label, and the integrity of the cap and seal.
  2. Testing of samples for the same criteria as used for raw materials, which includes testing for microbes, appearance, flavor, aroma, texture, disintegration, and friability.
  3. Verification that the average capsule or tablet weight, the bottle count, and the net weight are within specifications.
  4. Review of the certificate of analysis from the vendor for accuracy.
We save a sealed sample of each lot of material as a Quality Control Retainer for one year beyond the shelf life.

Product Release

After a raw material or finished product has cleared all Quality Assurance testing, a "Quality Control Release" is issued, which allows the raw material to be used in production, and finished products to be sold.

Quality Assurance Record Keeping

Meticulous records are kept, as follows:

  1. Harvest records
  2. Independent lab test reports
  3. In-house test data
  4. In-house inspection data sheets
  5. Certificates of analysis


Good Manufacturing Practices (GMP)

Simplexity Health adheres to FDA regulations for Good Manufacturing Practices for foods. The FDA GMP regulations cover every facet of manufacturing within the categories listed below. (For example, the "personnel" category requires employees to be trained and educated to perform their jobs, and to wear GMP garments and hairnets, and prohibits eating, drinking, and tobacco use in GMP areas.) The FDA's "Current Good Manufacturing Practices in Manufacturing, Packing, and Holding Human Food" covers:

  1. General Provisions
  2. Personnel
  3. Plant and Grounds
  4. Sanitary Operations
  5. Sanitary Facility and Controls
  6. Equipment and Utensils
  7. Processes and Controls
  8. Warehousing and Distribution
  9. Defect Action Levels

Regulatory Audits

  1. The Oregon Department of Agriculture inspects Simplexity Health's production and storage facilities three or four times a year. These inspections are unannounced.
  2. The FDA inspects food facilities like Simplexity Health on a random basis (we have received three such visits in the last five years). These inspections are also unannounced.
All inspections by regulatory agencies have fully met each agency's criteria.



Organic Certification

Since 2001, Simplexity Health's facilities and microalgae have been certified organic according to the U.S. Department of Agriculture's National Organic Program standards. OCPP/Pro-Cert of Canada performs a thorough annual audit at Simplexity Health's Klamath Falls facilities. During this time, Pro-Cert representatives review our records and processes, and inspect the facilities as well as the Upper Klamath Lake watershed. Simplexity Health currently offers seven organic-certified products. We will continue to increase the number of organic-certified products in the future.


Kosher Certification

Star-K of Baltimore, Maryland, certifies Simplexity Health's facilities and products to kosher standards. A representative from Star-K inspects our facilities and products, and reviews our documentation annually. Representatives for Star-K also inspect any vendors that produce kosher-certified products for Simplexity. Simplexity Health currently lists 22 kosher-certified products. We will continue to increase the number of kosher-certified products in the future.


Halal Certification

Halal is an Arabic word meaning 'lawful or permitted.' The internationally respected Islamic Food and Nutrition Council of America (IFANCA) developed a documented procedure for producing halal products that assures methodical cleanliness and consistency throughout the production process. IFANCA inspected Simplexity Health's facilities and processes, including equipment, ingredients, cleaning procedures, and records. At this time, four Simplexity products are halal-certified: Alpha Sun® capsules, Essentials™, StemPlex®, and SBG Zymes® Plus. IFANCA's halal certification symbol, the Crescent M, will be displayed on these products' labels as soon as possible.


Self-Audits

As a proactive step, Simplexity Health's Quality Assurance department performs quarterly self-audits to detect potential problems and take corrective action in anticipation of regulatory audits.


Vendor Audits

Simplexity Health audits vendors that produce products for Simplexity to verify GMP compliance.