Manufacturing Quality Control
Questions & Answers
What makes Infinity2’s manufacturing & quality control exceptional?
More than science, there is an art to formulating a synergistic blend of broad-spectrum enzymes, herbs and other ingredients to deliver specified nutritional support. Practicing this highly scientific art requires a combination of specialized expertise in enzymology, biochemistry, phytochemistry, quality control and manufacturing.
Infinity2 has entered into a strategic alliance with the most prestigious enzyme manufacturing company and has affiliate partnerships with 10 other high-ranking quality manufacturers in the health and nutritional products industry–all of which manufacture Infinity2’s products to our maximum standards for quality control and efficacy. This team of manufacturers possesses a unique and proprietary manufacturing component that places our operation above the rest. Our manufacturing partnerships bring unmatched ingenuity and experience to the process. Our team of experts has laboratories with the capability to perform enzyme analysis, compendial assays, thin-layer chromatography, high-performance liquid chromatography, nuclear magnetic resonance, electron paramagnetic resonance and routine microbiological screening.
Infinity2’s skill and commitment to excellence is vitally important because the manufacturing of enzyme-based dietary supplements is a complex operation. Infinity2 is unique in its commitment to:
- The highest quality ingredients and vendor certification program.
- Exceptional quality control procedures and specialists.
- The highest quality manufacturing processes.
- Guaranteed cellular delivery through CAeDS®.
- Guaranteed satisfaction.
Why are Infinity2’s products the best?
Years ago Infinity2 foresaw that the future of nutrition would be in cellular delivery. That is, assuring that the supplements you swallow are fully used by your body and not just simply passed through. But nobody was successful in figuring out how to get it done – until Infinity2. CAeDS® (Chelate Activated Enzyme Delivery System) is Infinity2’s hallmark of quality and the most powerful principle behind Infinity2’s unrivaled products. Many companies claim their products are the best, but only Infinity2 has CAeDS® to guarantee that each ingredient in each product is actually absorbed and used by the body.
Our unique CAeDS® (Chelate Activated Enzyme Delivery System) guarantees that the nutrients in each formulation are absorbed and used by your body. In addition, each formulation is created based on five very simple but powerful principles, which we call our product philosophy. Each product (1) provides guaranteed cellular delivery through CAeDS®, (2) is wholistic, (3) is formulated to obey the laws of nature, (4) is backed by patents and research and (5) is based only on needs.
Instead of merely seeing how many ingredients can be added to make the label appear flashier, Infinity2 makes sure that each product contains only those nutrients that your body will recognize, absorb and use to promote optimum health.
What is CAeDS®?
CAeDS® (Chelate Activated Enzyme Delivery System) is an exclusive process developed by Infinity2’s Product Formulation Team. CAeDS® was developed to ensure that cellular nutrition could be achieved. The CAeDS® trademark name refers to a combination of ingredients (enzymes, minerals and other nutrient co-factors), which ensure that each of our products is bioavailable, absorbed and transported to the cells of the body. CAeDS® provides the necessary minerals and co-factors to ensure optimum enzyme activity without robbing vital nutrients from the body. The enzymes in CAeDS® are precisely coordinated with the nutrients in each supplement to achieve optimum delivery of the nutrients. The patented Albion chelated minerals are used to fully activate the enzymes, thereby producing the unique system of nutrient delivery. In addition, CAeDS® guarantees that the nutrients in each product are delivered to specific tissue sites in the body.
Why is an enzyme delivery system necessary? What happens if a supplement
does not have a delivery system?
The body’s natural processes call for coordinated enzymes and minerals to be present in order for nutrients to be delivered to the cells of the body. As a result, certain minerals and co-factors must be present in order for enzyme activity to occur. Without these necessary co-factors, enzymes work less efficiently and enzyme activity robs the body’s nutrient stores. Without a delivery system, supplements taken in high dosages or over a long period of time may leach minerals from the body’s stores.
Infinity2 Quality Control
What quality control steps and analysis are used in manufacturing Infinity2 products?
Over 30 years of active experience in research, laboratory analysis, and quality control allows our manufacturing staff to conduct sophisticated quality checks. These quality checks include thin-layer chromatography and high-performance liquid chromatography (HPLC) to ensure the quality of the ingredients; microbiological assays to ensure safety; enzyme analysis to ensure maximum enzyme activity; probiotic assays to ensure a viable cell count; and nuclear magnetic resonance (NMR) spectroscopy to ensure the bond stability of the amino acid chelated minerals.
What standards do the Infinity2 quality control personnel use?
Infinity2’s quality control laboratory specialists use the standards established by published compendial sources including the Food Chemical Index and the United States Pharmacoepia. Their resident staff members represent more than 30 years active experience in research, laboratory analysis and quality control, including an FDA-trained microscopist for botanical identification.
Which steps of the manufacturing process utilize quality assurance procedures?
Our quality assurance team assesses each step of the manufacturing process – blending ingredients with consistent uniformity for encapsulating; microbiological contamination analysis testing of each batch; complete bottling, labeling and packaging for ready shipment; and quality control inspecting 100% of encapsulated and bottled products.
Infinity2 also employs regular quality checks and the in-house tests are backed by independent laboratory analysis. We are able to maintain high quality because Infinity2’s premium supplements go through an average of three times as many quality assurance steps as the law requires and are inspected and quality tested at every phase of production. As a matter of fact, 100% of our capsules are visually inspected before final bottling!
Do you assay every batch?
What method do you use to assay?
Every batch undergoes a microbiological contamination analysis. In addition, each raw ingredient is tested for safety, accuracy and quality to ensure that the ingredient is 100% of what the grower claims. Each raw ingredient is spectrographically analyzed using both thin layer chromatography as well as HPLC "fingerprinting" of the nutrient’s biological makeup.
Are the products from Infinity2 FDA approved?
The FDA only grants approval on substances considered to be drugs. Therefore, the FDA approval process is not applicable to Infinity2’s all-natural products. Nevertheless, every Infinity2 product is in full compliance with all applicable FDA regulations and all ingredients in Infinity2 products are in the GRAS (Generally Regarded As Safe) category.
What is your guarantee compared to your label claim?
Infinity2 stands by the quality of our products with a 100% money-back satisfaction guarantee. Many products fail to meet the claims they make on the label, but Infinity2’s products have been tested and shown to meet or exceed label claims in all cases. We guarantee it.
The FDA now requires that vitamins and other dietary supplements include labels similar to those found on all commercial foods. The label includes nutrient information and lists all ingredients including identifying parts of plants from which ingredients may be taken, but the quality of the supplement is not evaluated. It is the responsibility of the manufacturer to make sure the label information is truthful and not misleading and to make sure that the content matches the amount declared on the label. When independent laboratories have tested supplements on the market, most supplements only contain 20% of what is stated on the label. In contrast, independent laboratory tests have shown that Infinity2 supplements provide 100% or more of what the label claims.
Does Infinity2 employ laboratory analysis to ensure potency, purity, activity and consistency?
Yes. It is a part of good manufacturing procedures (GMP) to perform quality checks and also to have in-house tests backed by independent laboratory analysis. Each batch is tested several times on a frequency determined by the batch size.
Do your products undergo a USP dissolution test?
Because Infinity2’s products are encapsulated or in powder form, the USP dissolution test is not applicable. Our capsules undergo a USP disintegration test to ensure that the whole-food ingredients contained in the capsule will be released into the intestinal tract where they will be available to the body.
Infinity2 Manufacturing
Do Infinity2’s manufacturing centers conform to the FDA Good Manufacturing Procedures?
Infinity2 maintains the highest quality manufacturing processes. In fact, our manufacturing processes meet or exceed every component of the current Good Manufacturing Procedures (GMP) for the supplement industry and we uphold the highest OSHA standards.
Although nutritional enzyme products are regulated as dietary supplements, Infinity2’s manufacturing standards far exceed governmental regulations. Infinity2’s team of manufacturers follows all current Good Manufacturing Procedures (GMP). Our strategic alliance operations meet the highest OSHA standards for air quality, and the packaging facilities are FDA-inspected. Quality control measures are imposed through our manufacturers’ in-house analytical laboratories to assure that these high standards are continually met.
Why does Infinity2 use only capsules and powders?
The nutrients in capsules are more available to the body than tablets. Tablets often have binding agents and a protective coating added, which makes it difficult for the body to absorb the nutrients. Even if the tablet dissolves, the nutrients in the tablet are often inactive. The processing techniques used to put nutrients into tablet form require extreme temperatures and/or pressures to compress the ingredients, which can destroy the vitamins, enzymes and food complexes rendering them useless to the body. Capsules are created under much milder conditions allowing the nutrients to stay in their original form and remain available to the body.
How are your products manufactured?
Our products are made using low temperature processing. Although this method is more expensive and time consuming than traditional methods, it is the method of choice for maximum quality since heat destroys many vitamins, enzymes, and phytonutrients.
Are any pesticides, herbicides, or chemicals such as propyl alcohol or benzene used in or on any of the products?
There are no pesticides, herbicides, or chemicals such as propyl alcohol or benzene used in or on any of the Infinity2 products or in any step of Infinity2’s product manufacturing process.
Does Infinity2 use preservatives?
No. Because preservatives are known to interfere with enzyme activity, Infinity2 does not use preservatives. We use only natural and naturally derived manufacturing aids – no artificial coloring, flavoring agents, salt or added sugar.
Highest Quality Ingredients
Does Infinity2 maintain any standards regarding the type of ingredients used in Infinity2 products?
Yes. Our commitment to excellence begins with sourcing the highest quality ingredients and managing a vendor certification program that standardizes ingredient specifications. Only the purest, 100% all-natural raw materials meet our standards. We do not market our products based on current hype, nor do we sacrifice quality or effectiveness for a less expensive ingredient. Infinity2 products contain only the highest quality and thoroughly tested natural ingredients. The potency and quality of our products are guaranteed.
What is Infinity2’s vendor certification program?
Even though we choose the most reliable sources for our ingredients, each raw ingredient is tested for safety, accuracy and quality to ensure that the ingredient is 100% of what the grower claims. Each raw ingredient is spectrographically analyzed using both thin-layer chromatography as well as HPLC "fingerprinting" of the nutrient’s biological makeup. If they don’t meet our extreme quality standards, the entire lot is rejected. Until a vendor can consistently demonstrate that they meet our strict standards for excellence, they cannot be considered a certified vendor and we will not use raw materials provided by that vendor.
Infinity2 Enzymes
What type of enzymes does Infinity2 use and why?
Infinity2 only uses plant-based enzymes because they are more effective than other types of enzymes for several reasons. First, plant enzymes have a broader pH activity range. This means they can help digest foods and remain active throughout the intestinal tract, which varies in pH. Second, they have more general activity, which means they can break down more types of protein, fat and carbohydrates. For example, the protease from a plant-based source will address a lot more protein bonds than the other proteolytic enzymes. Third, they have no side effects. Pure plant enzymes do not interfere with the natural functioning of the body and therefore have no side effects.
Not only do we use the highest quality enzymes available, Infinity2 has carefully studied each enzyme to discover what it needs to be fully active, and then included those co-factors to insure maximum enzyme activity in these exclusive formulations.
Why has Infinity2 chosen not to use pancreatic or animal enzymes?
Pancreatic and animal enzymes such as pancreatin and pepsin are only active in specific pH and temperature ranges. For example, pepsin is a proteolytic enzyme usually prepared from the stomach of pigs and is typically only active at temperatures that are higher than normal human body temperatures, making it ineffective for use in human nutritional formulas. Pancreatin (a substance from the pancreas, usually a hog or ox, containing enzymes) is only active in an alkaline setting of 8.0 to 9.0 pH. This pH occurs within the small intestine after the majority of carbohydrate and protein digestion has already taken place. Pancreatin and pepsin are not used in any of the Infinity2 formulations because they are from animal sources that are not usually found in the human diet and are typically only active in one stage of digestion.
Are all enzyme supplements the same?
No. Only our supplier produces enzymes specifically for use with foods. Other enzyme supplements on the market may utilize enzymes, which are intended for making cheese, removing stains, or some other industrial or processing use.
Does stomach acid destroy Infinity2 enzymes?
There is no research or evidence, which indicates that Infinity2 enzymes are destroyed by stomach acid. To the contrary, our enzymes are designed to work well in the environment of the stomach.
Does Infinity2 use special coating systems to protect the enzymes during digestion?
No, it is not necessary to use special coating systems for Infinity2 enzymes. Special protective coating systems are typically used with pancreatic enzymes that are only active in alkaline pH of the small intestine. The special coatings for pancreatic enzymes are an attempt to protect the enzymes from destruction in the acid pH of the stomach and allow them to reach the small intestine. Infinity2 uses plant enzymes that are active in the wide pH range found in the digestive system, including the acidic environment of the stomach, which eliminates the need for special coatings.
How are plant enzymes produced and how are they grown?
The production of plant-based enzymes consists of making a cell culture fermentation using organic whole grain rice as a nutrient base. The fermentation process produces a rich broth containing enzymes. After fermentation, the enzymes, in liquid form, are separated completely from all organisms and nutrients by microfiltration. This broth is filtered five to six times. The result is a very pure protein solution, which is rich in enzymes. This solution is then freeze dried to produce a stable, concentrated enzyme powder, which is used in our products.
Infinity2 Minerals
What minerals does Infinity2 use and why?
Minerals are important for human nutrition and are also required for proper enzyme activity. The minerals used in the Infinity2 formulations are carefully chosen to not only improve health, but to ensure maximum activity of the enzymes included in Infinity2’s unique enzyme delivery system (CAeDS®). Only minerals from Albion Laboratories meet Infinity2’s stringent requirements for quality and our wholistic formulation philosophy.
Infinity2 uses only amino-acid chelated minerals from the only company that holds a patent on that process, Albion Laboratories. Other mineral supplements on the market claim to include chelated minerals, but often use admixtures and not true amino-acid chelates. Albion amino acid chelates are created by forming a bond between a mineral and an amino acid in order to facilitate absorption and ensure that the cells can use the mineral.
How can you be sure it is a true chelate?
Various instruments and methods have been used to demonstrate that Albion amino acid chelates are true chelates. These include: electron paramagnetic resonance (EPR); X-ray diffraction spectrometry; infrared spectrophotometry (IR) and Foureir transformed infrared spectrophotometry (FT-IR); nuclear magnetic resonance (NMR); scanning electron microscopy (SEM); mass spectrometry; polarography; photoelectron spectroscopy; and thermal decomposition. Albion Laboratories continues to ensure that the minerals they produce for Infinity2 are true chelates by running these types of tests to ensure bond stability and quality.
Infinity2 Probiotics
Which probiotics does Infinity2 use?
Infinity2 uses probiotics produced by Dr. Khem Shahani, because they are stabilized using a unique process that protect the probiotic bacteria against oxygen, humidity, light, and heat.
Infinity2 products that contain probiotics include: Total Flora Support, Total Body Flora, Essentials For Life 2 and ImmunePlus with Colostrum. Total Body Flora, Total Flora Support and Essentials For Life 2 contain 12 strains of probiotic bacteria that have been shown to be beneficial to humans. These bacteria have been specifically selected because of their synergistic effects in promoting health. ImmunePlus with Colostrum contains four strains of probiotic bacteria, which not only promote health, but have been shown to improve the immune system by enhancing the activity of blood phagocytes.
Do the probiotics adhere to the gastrointestinal mucosa in humans?
Yes. Numerous studies have shown that the probiotics used in Infinity2 products adhere to the gastrointestinal mucosa in humans. In addition, the unique stabilization process developed by Dr. Khem Shahani not only ensures that the probiotics remain viable, but makes the mucous membrane in the gut more conducive to implantation.
How are Infinity2’s probiotics produced?
Infinity2’s probiotics have the highest quality, potency and stability. These important friendly bacteria are grown in a special broth-like medium of organic nutrients so that the organisms can grow quickly and effectively. They are then separated and concentrated using centrifuge and are grown into separate cultures for renumeration. Prior to freeze-drying, the probiotics are protected using special cryoprotective agents.
Many probiotic manufacturers stop at this step, but Infinity2’s commitment to quality requires that the probiotics are then stabilized. The unique stabilization process developed by Dr. Khem Shahani helps to protect the probiotic bacteria against oxygen, humidity, light, and heat. The stabilization process uses herbs, amino acids, vitamins, peptides, and reducing agents, which not only ensure that the probiotics remain viable, but make the mucous membrane in the gut more conducive to implantation.
Infinity2 Herbs and Whole Food Ingredients
Where does Infinity2 get its raw materials?
The raw materials in our products are from the highest quality sources. Because the nutrient content of plants varies depending on growing season, Infinity2 hand selects its growers and suppliers to be sure that the ingredients contain the highest possible nutrient content.
In addition, each of these growers and suppliers must undergo Infinity2’s rigid vendor certification program. The vendor certification program ensures that the raw materials are of the highest quality.
Which are better: extracts or whole foods?
We strongly prefer to use whole food substances rather than extracts. The whole food is superior in nutritional value in most cases. In a small number of instances, we utilize extracts when the nutritional value of a particular component of whole food is improved by the extraction process.
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