At Natural Immunogenics, we are committed to the science and quality of our products, and our laboratories are a testament to this commitment. Equipped with some of the world’s most advanced analytical equipment, the laboratory is designed for both the rigorous testing that every batch of finished product is subjected to before its release to the public and the continuing exploration of the field of colloidal science, including the many health benefits of silver and other minerals.
One of our laboratories’ primary purposes is to ensure the quality, purity, identity, composition and strength of our products. Since 1999, our laboratory has also conducted in-depth analyses on hundreds of competing brands from the United States, Canada, Australia and Europe. The laboratory supports many scientific and R&D projects as well.
Collectively, our team of scientists has decades of experience in the field of colloidal science, and it includes in-house experts specialized in the field of metal nanoparticle characterization.
First in Class Laboratory Capabilities for Science, Research, Quality and Testing include:
- Transmission Electron Microscope (TEM). Particles at the nanometer size scale require a TEM to visualize. Our Phillips CM 12 TEM enables over 300,000X magnification by using an electron beam for illumination, instead of visible light (as used with more traditional microscopy), in combination with an AMT
- XR50 CCD Digital Camera. Instruments like a TEM are typically only found in research university core facilities. Natural Immunogenics is the only company in the industry to our knowledge that has invested in an in-house TEM, demonstrating the level of commitment we have to ensuring the quality of the product. The TEM has been critical in both product development and ongoing quality assurance of the hydrosols we produce.
- Atomic Absorption Spectrophotometer (AAS). AAS is widely accepted for precise determinations of metal concentrations, such as silver, copper and gold, at the parts per million (ppm) level. Every batch of hydrosol produced is analyzed by AAS upon completion for quality control purposes, ensuring the concentration of silver in every bottle meets our demanding specifications. Our laboratory is equipped with two cutting-edge instrument systems. The PerkinElmer PinAAcle 900F is engineered with an array of technological advances offering a variety of configurations and capabilities, including an eight-lamp mount (allowing quick analyses of various metals) and automated flame-and-burner assembly optimization for enhanced productivity. The PerkinElmer PinAAcle 500F, a newer model with a smaller footprint and more efficient software workflows, expands our analytical capabilities.
- Dynamic Light Scattering (DLS). This particle size measurement technique is complementary and orthogonal to TEM. By enabling measurement of particle size distributions of particles in a solution or suspension, it proves to be a very useful research tool.
- Ultra Violet – Visible Spectroscopy (UV-Vis).The color of a solution can be measured quantitatively through UV-Vis spectroscopy, providing chemical identity and concentration information. A Thermo Fisher Scientific Genesys™ 150 UV/Vis Spectrophotometer is utilized, offering compact, powerful, modular operations full on-board software.
- Total Organic Carbon Analysis (TOC). Our Phoenix 8000 UV-Persulfate TOC Analyzer uses a method of TOC analysis that achieves outstanding accuracy and precision. Equipped with a high capacity robotic auto-sampler, the Phoenix is perfect for applications requiring high sensitivity testing capabilities for use in testing all kinds of water, with sensitivity down to parts-per-trillion. Examples of water testing capabilities include drinking, pharmaceutical-grade, clean-in-place, water-for-Injection, ground, surface, semiconductor-grade, steam power and ultra-pure water.
- Pharmaceutical-Grade Water Purification Systems. We have two custom-designed 8-stage water filtration systems that provide continuous water meeting NF-USP standards for pharmaceutical-grade purified water. These state-of-the-art water systems are maintained and serviced exclusively by an industry-leading water technology company.
- Endotoxin testing. Our instruments utilize the FDA approved test method called the Kinetic Chromogenic LAL (Limulus Amebocyte Lysate) Assay, a sensitive colorimetric assay that can detect endotoxin levels in solutions at concentrations as low as 0.005 endotoxins units per milliliters (EU/mL). Endotoxins, which are a type of pyrogen, are lipopolysaccharides present in the cell walls of gram-negative bacteria that, as a class, can cause negative immune system reactions, which can be harmful or even fatal if administered to humans above certain concentrations.
- Microbiological testing. Our laboratory is equipped with microbiological testing capabilities to ensure no contamination from microorganisms is present in the products.
- Additional testing. Our laboratory includes a wide variety of other standards and specialized equipment, including pH and conductivity meters, ion selective electrodes, viscometers, analytical scales and balances, spectrometers, centrifuges, hot plates, incubators, water baths, pumps and power supplies.
Our laboratory operates under Good Laboratory Practices standards (GLP), and our test methods are validated, providing the highest confidence in all results.
Laboratory equipment and instrumentation is installed with the necessary performance qualification procedures and is routinely calibrated by ISO-certified third parties to ensure they meet all variance requirements. Daily verification of calibration of analytical equipment is also performed by qualified laboratory technicians using NIST-traceable standards.
No other company has invested so deeply in the process of ensuring product purity and quality, or in securing and maintaining complex equipment and machinery, such as the TEM. Beyond equipment, our laboratory is also fitted with HEPA filtration systems, dedicated compressed air and gas systems, seamless floors and special lighting. Our attention to detail extends to every aspect of our operations.
With a commitment to strict manufacturing standards, NSF International has certified our Quality System as fully compliant with current Good Manufacturing Practices (cGMP), confirming our high operating standards through independent verification of our internal processes, procedures, and documentation.
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