i26 PRODUCTION-QUALITY CONTROL
Your Quality Choice
by Leslie Confer, BS
Member of American Society of Quality Managers
Quality Assurance and Quality Control
Arkion Life Sciences, LLC., Wilmington Delaware
Your Body's Defender of Health
Your body's i system is Nature's way of insuring continued wellness by protecting the body from a large variety of external and internal stresses.
The dietary supplements, i26™ and i26™ COMPLETE Support, are developed with proprietary patented technologies to help your body support and maintain its i, digestive, and cardiovascular systems, as well as joint and connective tissues. Also, daily consumption of these products enhances energy and feelings of well being.
Antigens Recognized by the Body as Foreign
The i system fights infection by identifying foreign agents (for example, pathogens like bacteria, viruses and fungi) that have entered the body. Upon detection, specialized white blood cells (plasma cells) send out a variety of antibodies to "tag" these agents for destruction by other white blood cells. The body identifies these agents by recognizing surface molecules (called antigens) as foreign. It is these substances, the antigens, which induce antibody production in the first place.
Naturally Occurring Antibodies
All higher level animals such as mammals naturally produce a many different types of antibodies to substances in their external environment. Examples of the wide variety of antigens that are naturally found in an animal's environment besides living organisms, such as bacteria and viruses, are: pollens and other plant derivatives, animal dander, particles such as dust and smoke, and natural and man-made chemicals.
Thousands of different types of antibodies occur naturally in animals and are present in very low amounts all of the time. All of the antibodies that are directed against these various antigens comprise the total antibody (or immunoglobulin) found in a particular animal.
Hyperimmunization-The Key to Maximum I Benefit
Through its proprietary layer hen inoculation program known as hyperimmunization, the chicken is stimulated to produce a wide spectrum of specific and non-specific i components.
Researchers have found that the hyperimmunization stimulates the production of i components that affect the digestive system and key immunological pathways. The process of hyperimmunization but shifts the i system's balance. A result of this hyperimmunization process is the concentration of i products in the egg that is used for i26 .
Building Quality into i26™
Poultry Flocks
Quality begins at the most basic level, the egg production farms. Quality Control and Assurance programs closely parallel the guidelines set forth in a compilation of federal regulations called the United States Code of Federal Regulations (CFR).
Farmers whose flocks are used to produce i26 eggs are required to participate in the National Poultry Improvement Plan as outlined in CFR-9.145. The Plan uses special measures to insure that the flock is kept free from Salmonella , Pullorum-Typhoid, Mycoplasma, and various other common poultry diseases. State authorized laboratories routinely test blood samples of the flocks. Qualified farmers are required to adhere to strict industry guidelines, and keep their chicken houses orderly and sanitary. The flocks are periodically inspected by state officials and by independent auditors.
Proprietary Spray Drying of Eggs
Eggs collected at each production farm are shipped to the spray drying facility and held in closely monitored refrigerated storage chambers until processing. After the eggs are broken and the liquid is collected, the egg material is pasteurized. A process called spray drying evaporates off the water from the liquid. This results in a high-grade fine egg powder that is i26 . Hundreds of thousands of dollars have been spent developing appropriate pasteurization and spray drying methods to assure that the i components retain maximum immunological effectiveness throughout the process.
Producing a Quality Product (GMPs and Quality Control)
The processing of i26 is carried out at USDA licensed manufacturing facilities that are required to follow current Good Manufacturing Practices (cGMPs) as outlined in Federal Regulations [CFR-21.110, 160]. GMPs help assure that i26 is safe and produced in a sanitary manner.
USDA inspectors constantly monitor operations to insure the safety and quality of each batch produced. Each batch of i26 is tested at the manufacturer prior to release in order to assure that the batch meets or exceeds the specifications of powdered egg for the egg production industry. These standards include protein, fat, and moisture. Also, each batch must be certified as having no detectable levels of living organisms such as aerobic bacteria, coliforms, E. coli, Salmonella, yeast, and molds.
Testing for Quality of Product (Quality Control)
Before packaging, each lot of i26 is again tested by an independent testing laboratory to assure 1) that it meets or exceeds the specifications of powdered egg for the industry and 2) that there are no living organisms that are potentially harmful to humans. These include tests for aerobic bacteria, coliforms, E. coli, Salmonella, yeast, and molds. i26 must also meet certain standards of identity for protein, fat, and moisture.
Assay of i26™ for Bioactivity
After much scientific investigation and development, biologists and technicians have successfully developed a test to track some of the specific IgY antibody that result from the inoculation of the hens. The test is based on a modern laboratory technology known as ELISA (enzyme linked immunosorbant assay).
Specific bacterial antigens found in the vaccine are selected as indicators of the hyperimmunization response. A mixture of these antigens is attached to a plastic "plate" (microtiter plate) containing 96 small wells. i26 is diluted in a liquid, then added to each of the wells. Any specific antibody in i26 will naturally bind to a specific antigen that has already been attached to a well. Egg powder from control hens that have not been immunized is also diluted and added to separate wells to act as a reference. Since regular egg material contains significantly fewer specific antibodies than i26, fewer antibodies will bind in the wells containing control egg material.
After washing away excess material, marker antibodies (antibodies linked to special enzymes) are added to each of the wells. These markers will tag any IgY antibody that is attached to an antigen. Once again, excess material is washed away and a solution is added that changes the color of each well containing specific antibodies. The special enzymes linked to the marker antibodies will turn the solution in the wells from clear to blue. The more intense the color, the more specific antibodies present .
Remember that control egg powder also contains small amounts of naturally occurring antibodies to these bacterial antigens. The amount of specific IgY antibodies in i26 is compared to the amount of specific IgY antibodies in the control egg powder. A significant increase in active antibody levels indicates the success of the hyperimmunization process and assures us that i26 has met specifications.
Certificate of Analysis for i26™ -Seal of Approval
Finally, a Certificate of Analysis (COA) is issued by the Quality Control group and accompanies each batch of i26. This COA certifies that the particular lot of i26 has been thoroughly tested and meets or exceeds all specifications. This Certificate of Analysis guarantees the highest confidence in the quality and safety of Egcel.
Your First Choice- i26™
Quality Governed by Good Manufacturing Processes
A full document trail is utilized to track product. The production of the finished BioChoice® dietary supplement is carried out at facilities that operate under cGMPs and are licensed and inspected by the FDA. Production, sampling, and testing guidelines closely parallel those set forth in the Code of Federal Regulations outlining the procedures and tests necessary to insure nutritional integrity [CFR 21.104-106]. All suppliers of the other raw ingredients used to formulate i26 COMPLETE Support [i26™ plus vitamins, minerals, and high protein sources] are required to certify that their material has been analyzed and meets these same high nutritional and quality specifications.
Types of Testing Conducted to Assure Quality
Analyses for marker vitamins, minerals, and microbiological contaminants are performed on every lot of i26 COMPLETE Support and/or i26 to insure that the material is properly fortified and safe. Other analyses include total protein, moisture, fats, ash, caloric content, total carbohydrates, and total dietary fibers. Modern analytical techniques are employed to insure the high quality standards for products.
Testing by Independent Laboratories
Independent testing laboratories are utilized for outside routine testing of Legacy products. These laboratories are FDA and USDA registered, which provide highly respected independent testing services to companies worldwide. The procedures used at these laboratories are approved by the Association of Official Analytical Chemists (AOAC), the American Oil [as in food] Chemists Society (AOCS), the American Association of Cereal Chemists (AACC), the FDA Bacteriological Analytical Manual (BAM), the USDA, and other organizations that collaborate and approve testing procedures for the food industry.
Testing for Safety
As part of cGMPs, i26 and the proteins and other raw materials used in the formulation of i26 COMPLETE Support are tested extensively prior to use. To insure the safety of , independent testing laboratories check each batch of i26 for microbes. Every lot of product is again tested after i26™ is blended with other nutrients [which makes COMPLETE Support] and final testing is performed on samples of packaged material before shipment to insure that the product is safe.
Testing for Quality
As a final step, each lot of i26™ and I Support passes evaluation by trained quality experts. Taste, color, odor, texture, and granulation must meet or exceed quality standards. Only after the lot passes all quality specifications is the product released for distribution to the consumer.
Documentation of Process
Each step of the manufacturing process is documented at great expense and effort, generating a "paper trail" of documentation. When you consume a serving of i26™ or i26™ COMPLETE Support, the documentation can track the eggs that were used to produce that product.
Certificate of Analysis for BioChoice® I Support--Seal of Approval
A COA (Certificate of Analysis) is issued for each batch of i26™ COMPLETE Support. The COA details the nutritional breakdown of i26™ and confirms that the batch is free from bacteria, yeast, and mold. Just as for i26™, the COA is the Seal of Approval that gives consumers the highest confidence in the quality and safety of BioChoice® I Support.
What Does This Mean to You, the Consumer?
It is well known that proper nutrition is necessary to maintain optimal health, including a properly balanced i system. i26™ and COMPLETE Support provide i support and they also support your body's i system and other normal functions by providing a balanced supplement of proteins, carbohydrates, vitamins, and minerals essential for growth and metabolism. We take great care to insure that our products meet or exceed the high quality and safety standards demanded by today's educated consumer. i26® is the first choice for supplemental natural i26™ support.
Legacy for Life on Twitter
Legacy for Life on Facebook
