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Commitment to Quality
LACTONOVA for years has set the standard by which companies in the industry are judged for product purity. Practitioners rely on Lactonova and its products as they are extremely hypo allergic, non-GMO and for the bioavailability of products.
Bioavailability, how effectively a nutrient is absorbed by the body, has always been a key component for Lactonova, non-GMO because our products come in the form of easily absorbable, shakers and capsules.
Purity at Every Level
For example, instead of purchasing prediluted vitamin D, as other companies do, Lactonova performs its own dilution to avoid detrimental ingredients, such as the preservatives or lactose that are found in many commercially available dilutions. Why must vitamin D be diluted? Because in its pure form, it is too concentrated to safely blend into a vitamin product. Pure vitamin D is 40 MILLION International Units (IU) per gram. The RDA for adults is 600-800 IU per
day. To ensure proper mixing, it must be made into a dilute powder that flows and does not lose potency. So, unlike companies that use prediluted vitamin D that contains unacceptable excipients and preservatives, at Lactonova, pure pharmaceutical vitamin D is first blended with pure mixed tocopherol vitamin E, and the resultant stable vitamin D is then blended with hypoallergenic cellulose powder. The final powder is blended in a large tumble blender and subsequently analyzed. Not only is the final product stable; it is also hypoallergenic and can be mixed homogeneously and at a safe level with other powders. Just as with vitamin D, Lactonova utilizes similar processes for other raw materials, such as vitamin K, leaving it to other companies to purchase commercially available raw materials filled with unacceptable ingredients and preservatives.
Ingredients You Don’t Want
Manufacturing encapsulated dietary supplements isn’t easy. Pure powdered ingredients are difficult to mix because they are either extremely dry, sticky with botanical oils, or attract unwanted moisture. So, most manufacturers add magnesium stearate and other agents such as lactose and dextrose to make the powder flow quickly and easily through their high-volume machines. Problem is, these additives may compromise the bioavailability of the nutrients in the supplement, and might cause allergenic problems. These excipients are utilized as flowing agents to ensure that maximum productivity is obtained from capsuling and tableting machines. There are documented detrimental effects directly attributed to long chain fatty acids utilized as manufacturing flowing agents. Every qualified pharmaceutical chemist recognizes that large fatty acids, such as magnesium stearate, can interfere with product dissolution and influence absorption. Virtually all companies, because of the economic impact, ignore this data. As with most industries, the bottom line dictates the level of quality and we at Lactonova does not use these flowing agents. The dietary supplement industry has one exception. LACTONOVA always. We care for your highly allergic, chemically sensitive, and immune-compromised patients health with our range of highest quality Dietary supplements.
Every manufacturer has two basic options when purchasing raw materials: purchase either truly pure raw materials, or purchase raw materials to which substances have been added to facilitate manufacturing. This fundamental dilemma tranallergic, chemically sensitive, and immune-compromised patientsslates to these very typical questions: “Do I purchase pure vitamin C or vitamin C with additives?” “Do I purchase pure B vitamins or coated B vitamins for taste masking?” “Do I purchase pure enzymes such as pancreatin, pepsin, and bromelain or enzymes diluted with lactose?”
There are few commercial sources for vitamins B12, D, K, or biotin that are not diluted with substances such as lactose, cornstarch, and preservatives such as BHT. That’s why we developed methods that allow us to use pure, undiluted sources of these nutrients.
GMPS & SOPS
GMPs are, in very basic terms, a method of ensuring consistency in manufacturing. They are a roadmap for quality – an instruction manual for everyone involved in the dietary supplement business. GMPs, if they are followed stringently, ensure that a product is made the same every time, with all people involved following the same steps to get the finished product. They also provide a high level of safety for the consumer, in that all aspects of manufacturing, including laboratory analysis, mixing, encapsulation, bottling, labelling, packaging, and shipping, are standardized. This minimizes the risk of mistakes in the manufacturing process that could lead, for example, to the wrong ingredients being included in a product or the wrong label being placed on a bottle.
From the GMPs, specific step-by-step instructions must be written for each and every aspect of manufacturing and must be followed by all employees involved in the process. These specific instructions are called Standard Operating Procedures (SOPs) and are one of the most important components of quality control. Lactonova Research’s SOPs have been developed over many years and are constantly being adjusted as improvements are made to manufacturing methods and quality control procedures. To illustrate the amount of detail included in our SOPs, consider this – our current GMP document consists of 60 pages; while we have more than150 SOPs (which are continually being added to and refined) that total more than a thousand pages.
The key to comprehensive quality control is the use of an in-house laboratory. Having an in-house, state-of-the-art laboratory is absolutely necessary to manufacture superior dietary supplements. Lactonova’s laboratory is a primary component to achieve our mission of maintaining strict control over every aspect of manufacture and quality. Our in-house laboratory allows for timely, accurate, cost-effective testing that ensures every product, from raw material to finished goods, meets all quality requirements. State-of-the art lab equipment includes:
High Pressure Liquid Chromatograph (HPLC) with Series 200 Diode Array Detectors and Series 200 Fluorescence Detectors
Every batch of every ingredient we receive is quarantined and tested for identity and purity before being allowed to be used in any Lactonova’s product. Some of our products are tested again after the mixing phase of manufacturing to ensure a homogenous mix of ingredients has been obtained. Then, every finished product is tested again before being released for sale. Such stringent attention to quality control is extremely difficult to accomplish without a state-of-the-art, in-house laboratory.
Team Lactonova comprises of highly experienced people involved in the quality control, quality assurance, purchase, production, and maintenance ensuring maximum food safety and highest quality. TUV SUD (Germany) Certified ISO 22000 Company.
The auditors from this official agency of the TUV SUD (Germany), whose certification is recognized and accepted worldwide, not only review our GMPs every two years but also conduct an on-site inspection of every aspect of Lactonova’s manufacturing and quality control.
The Lactonova’s commitment to quality is demonstrated by the diligence necessary to maintain the level of pharmaceutical standards required. Quality is the Lactonova’s mission, more than just a mission statement.