Our custom laboratory is equipped with some of the world’s most advanced analytical equipment. The lab was designed not only for the rigorous testing that every batch of finished product must go through before being released to the public, but also to continue to explore the expanding world of colloidal science and the health benefits of silver.

One of our laboratory’s primary purposes is to ensure the quality, purity, identity, composition and strength of our products. It is also utilized to analyze competitors’ products. Since 1999, our lab has conducted in-depth analyses on hundreds of competing brands from the United States, Canada, Australia and Europe. These comparisons are kept up to date in our Comparison Tool. The laboratory also supports many scientific as well as R&D projects.

Our team of scientists collectively have decades of experience and includes in-house experts specialized in the field of metal nanoparticle characterization.  Our core capabilities include:

  • Transmission Electron Microscope (TEM). TEM is used to measure the extremely small size of our products’ particles, which ensures their maximum efficacy.* TEM allows over 300,000X magnification by using an electron beam for illumination instead of visible light. Our Phillips CM 12 TEM has been critical in both product development and ongoing quality assurance of the hydrosols we produce. An AMT XR50 5 Megapixel CCD Digital Camera streamlines image collection.

  • Atomic Absorption Spectrophotometer (AAS)
    . AAS is widely accepted for precise determinations of metal concentrations, such as silver and copper. The PerkinElmer PinAAcle 900F is engineered with an array of technological advances offering a variety of configurations and capabilities. It features cutting-edge fiber optics to maximize light throughput for improved detection limits, as well as 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, was recently purchased and added to the lab.

  • Dynamic Light Scattering (DLS)
    . This particle analyzer measures the size and zeta potential of nanoparticles with groundbreaking speed and high precision, utilizing two independent detection systems that operate in parallel. Precise measurement of the size, structure and charge of particles can be provided, ranging from 0.4 nm to 10,000 nm in diameter, in as little as one second, the fastest particle analysis available. An Avalanche photodiode detector provides size measurements, and 31 independent photodetectors measure zeta potential, dramatically reducing analysis time and increasing accuracy. This powerful Particle Analyzer provides more quantified particle data than the electron microscope, with less operator time. The investment helps to ensure uniformity of our particle size and charge from batch to batch, and also to verify whether competitors’ products are honest in their particle size claims. This technique is complementary and orthogonal to TEM.

  • 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 Beckman DU 530 and a PerkinElmer Lambda XLS+ are utilized, both 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, precision and long-term calibration stability, with a high capacity robotic XYZ auto-sampler. The Phoenix is perfect for applications requiring high sensitivity, such as drinking, pharmaceutical grade, Clean-in-Place, Water-for-Injection, ground, surface, semiconductor grade, steam power and ultra-pure water, with sensitivity down to parts-per-trillion.

  • Pharmaceutical-Grade Water Purification.
    We have two custom-designed 8-stage water filtration systems that provide continuous pharmaceutical-grade purified water meeting USP-NF 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.

Microbiological testing to include evaluation of pyrogens and endotoxins: Our instruments utilize a test method approved by the FDA. It is an in-vitro assay used to detect the presence and concentration of bacterial endotoxins usually applicable in drugs and biological products, and is an important part of pharmaceutical microbiology. Endotoxins, which are a type of pyrogen, are lipopolysaccharides present in the cell walls of gram-negative bacteria. Pyrogens as a class are fever-inducing substances that can be harmful or even fatal if administered to humans above certain concentrations. Our instruments utilize 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).

Additional testing: Our laboratory includes  a wide variety of other standard 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 all our test methods are validated, leaving no to extremely reduced possibility of false results.

All laboratory equipment and instrumentation are installed with the necessary performance qualification procedures and are 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.

Next: Regulatory Compliance