Product Quality Standards
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Product Quality Overview
Enzyme Essentials proudly sells the private label brand of Transformation Enzyme's (TEC) line of products.
It is now a scientifically established fact that nutrition and digestion work together to constitute one of the main factors that controls overall health. Recent research studies have shown that, under certain conditions, proper selection of acid-resistant enzymes with a wide range of pH stability and activity can assist the digestive process. To meet these requirements, TEC’s scientific staff has drawn on its decades of combined experience in biochemistry, nutrition, and cellular/molecular biology to formulate and develop highly specific digestive enzyme products under GMP (good manufacturing practices) and pharmaceutical grade standards.
Although we contract out the actual manufacturing of our products in a close joint venture arrangement, we are actively involved in the sourcing, selection of the various ingredients and conduct audits of the manufacturing processes. Our manufacturing company has been certified as a GMP company and has received several awards and certifications.
We use various assays and tests as specified in the Food Chemical Codex (4th edition) depending on the ingredients. The testing policies in our manufacturing processes are mandated in Standard Operating Procedure (SOP) form, and are on file at our manufacturing facility. In addition, the facilities, personnel, and record keeping comply with all applicable Current Good Manufacturing Practices as regulated by the US FDA.
To each raw material received, a unique set of methodologies and specifications is developed in accordance with all available compendial literature. This set of methods and specifications is then applied to each subsequent batch received. All reasonable efforts are made to completely and effectively characterize each raw material intended for production.
A microbiological testing program is in place and includes screening for the following contaminants: Aerobic Plate Count, Escherichia coli, Coliform, Staphylococcus aureus, Salmonella species, Yeast, and Mold.
We do not use any harmful fillers, excipients, or binders. We use vegetable and gelatin derived capsules. Most of TEC products are animal-free. Some products contain animal by-products but are certified free from any contamination, including BSE. TEC does not use irradiated, fumigated, or GMO raw materials. The extraction methods vary from material to material. Herbal extracts are purchased based on a set of specifications such as potency and purity.
Each component, raw material, label, and manufacturing stage of a given product is assigned a 5-digit item code coupled with a 3-digit batch number. This system has numerous points of reconciliation (for example: shipping, purchasing, customer service, manufacturing, QC). TEC along with its manufacturing partner have a customer complaint procedure, recall procedure, and quarantine (hold) procedure in place.
TEC enzyme products are individually formulated to hydrolyze the various food molecules. Our protease products constitute a blend of several proteases that have been carefully selected to sustain the gastric environment and maintain their proteolytic activity throughout the gastrointestinal tract. TEC selects lipase, amylase, lactase, phytase, pectinase, cellulose, and other enzymes based on their resistance to low gastric pH and their support of the digestive system.
A multidisciplinary staff of nutritionists, biochemists, chemists, microbiologists, physicians, and dieticians is involved in the design, formulation, and production of our various products. This group of experts also scrutinizes and monitors the selection of ingredients to ensure that they are selected based on benefits observed through peer-reviewed scientific data. In support of the nutritional benefits of TEC products, technical references to the literature are provided upon request. Maintaining an active collaborative relationship between academia and the industry has allowed TEC’s technical science team to continually stay on the forefront of new innovations and to always be aware of new research findings.
TEC raw enzyme products are obtained from exclusive suppliers who have several decades of technical and commercial enzyme production experience. Their production methods have been standardized in order to ensure reproducible quality. Furthermore, the downstream processing methods that lead to pure enzyme preparations are done under highly scientific and aseptic conditions in order to maintain the stability and safety of the enzyme products.
TEC diligently sources out and selects only the acid-resistant enzymes that have wide pH stability and that maintain their activity within the temperatures of the gastrointestinal tract. The high turnover rate (the enzyme activity) of our enzymes refers to the number of times (the number of cycles) that the enzyme will perform its activity per unit of time.
Because of the variety of food biomolecules, it is best to take dietary digestive enzymes that can hydrolyze several biochemical bonds in the food biomolecules. In order to accomplish that, TEC uses formulations with a mixture of proteases (endopeptidases and exopeptidases), glycosidases, lipases, esterases, pectinases, and phytases. TEC ensures consumers that they will receive adequate enzyme formulations and that they will be provided with the nutritional and biochemical education to make a better selection according to their specific biochemical needs.
Transformation Enzymes are biomolecules that have been purified from microorganisms, plants, and/or animals. These dietary enzyme preparations are highly purified under manufacturing conditions that are aseptic and first-class, thus guaranteeing their safety and effectiveness. Steady and rigorous quality behind manufacturing practices help maintain a clean environment which prevents contamination of the products and ensures consumer satisfaction.