MADE IN THE USA
QUALITy MANUFACTURING MADE IN THE U.S.A.
Ancient health-care traditions combined with modern scientific research, fertile soil, correct growing conditions, and ISO- and FDA-inspected extraction facilities of the raw material ingredients, technical expertise and strict adherence to Quality Control and FDA regulatory and cGMP procedures make Ultrra’s products among the very finest in the industry.
At Ultrra’s manufacturing facilities, we:
✓ Ensure the finest quality ingredient raw materials are used
✓ Follow FDA regulations. Our Contract Manufacturing facility follows 21 CFR Part 111 Code of regulation by FDA
✓ Support the highest level of internationally accepted manufacturing quality standards with International Food Standard (IFS) certificates. International Food Standard certificate (IFS) by Det Norske Veritas
✓ Comply with current Good Manufacturing Practices (cGMPs) with written Standard Operation Procedures (SOPs).
✓ Maintain the highest health standards with GMP certification from Utah State Department of Agriculture and Foods (UDAF).
✓ Comply with a rigorous third-party certification of in-house lab performance.
✓ Ensure finished products meet and exceed quality standards. We adhere to United States Pharmacopeia (USP)
✓ Comply with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, a basic requirement for the FDA.
✓ Check all ingredients for identity, microbial and efficacy. We have strict Quality Control procedures in place using HPLC, TLC and ICP testing.
✓ Provide 100% traceability for all Ultrra ingredients from seed to shelf, because we supervise growing, farming, and do the extraction of the standardized compounds.
✓ Do accelerated stability and real-time stability testing prior to issuing expiration dates.
What makes the Ultrra product line so powerful and unique is how it is designed. Every ingredient in our blends is the purest form available from around the world. In fact, from seed to bottle we know exactly where it is grown, tested, extracted, tested again, blended, tested again and bottled. Even the bottles and lids are QC tested for contaminants!
The facilities are FDA regulated, the manufacturing process is cGMP, with strict Quality Control and Quality Assurance testing
The three main Quality Control tests are for Identity, Microbial, and Efficacy
First, every single ingredient is identity-tested. This takes one day. The tests are done using HPLC, TLC and ISP:
✓ HPLC: High-performance liquid chromatography (sometimes referred to as high-pressure liquid chromatography). HPLC is a chromatographic technique that can separate a mixture of compounds and is used in biochemistry and analytical chemistry to identify, quantify and purify the individual components of the mixture. [Chromatography: separation of mixtures using laboratory techniques]
✓ TLC: Thin layer chromatography is a chromatography technique used to separate mixtures. Thin layer chromatography is performed on a sheet of glass, plastic, or aluminum foil, which is coated with a thin layer of adsorbent material, usually silica gel, aluminum oxide, or cellulose (blotter paper).
✓ This layer of adsorbent is known as the stationary phase. [Adsorption is the adhesion of atoms, ions, biomolecules or molecules of gas, liquid, or dissolved solids to a surface.]
✓ After the sample has been applied on the plate, a solvent or solvent mixture (known as the mobile phase) is drawn up the plate via capillary action.
✓ Because different analytes ascend the TLC plate at different rates, separation is achieved.
✓ ISP: Induction Plasma testing for the detection of trace metals, such as zinc.
✓ This analytical technique produces excited atoms and ions that emit electromagnetic radiation at wavelengths characteristic of a particular element.
Second, Microbial testing is done to look for 6 main pathogens (germs or microbes):
✓ E. Coli
✓ Pseudomonas (a common bacteria found in humans and animals that can cause infection).
✓ Staphylococcus is a genus of Gram-positive bacteria. [Under the microscope, they appear round (cocci), and form in grape-like clusters.]
✓ Coliform bacteria: found in water and vegetation, indication of bacteria and viruses, when present.
✓ Entero bacteria, usually residing in the guts of many animals. [A clean environment and plenty of hand washing usually eliminates it.
✓ All workers in the production area have to wash and sanitize their hands for at least 15 to 20 seconds before going into the production area, after eating, going to the bathroom and smoking.
✓ The Microbial testing is two to five days using petri dishes (shallow dishes).
✓ We even test the bottles and lids with a swab before we put them on the filling lines
✓ Then we do QC testing on the finished product after they have been bottled and labeled, in case there was any contamination on the lines. This takes 5 working days.
Thirdly, we test for Efficacy: We have specifications of each ingredient that state the strength of the particular compound, such as 10% forskohlin in the Coleus forskohlii in the Slim.
✓ We use HPLC testing using gas chromatography to test for these compounds.