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Quality Assurance Testing

Microbiological Testing

ATP System - This is based on the measurement of adenosine triphosphate (ATP), a substance found in all organic material and microorganisms. When the reagent in the swab comes in contact with the ATP in a sample, a reaction takes place that produces light. The system then measures the light output. Higher level of food residue and microorganisms on a surface or in water correlate to more ATP and more light is produced; high numbers mean dirtier surfaces. By screening for bacteria on machinery and equipment in the production area, we can evaluate the standard hygiene level and the efficiency of our cleaning procedures. This ensures that our products will not become contaminated during manufacturing.

Total Plate Count Testing - To determine the number of microbes that might be contaminating a product, we take a total plate count. We test a sample of raw material or finished product and determine the amount of aerobic microbe contamination in the sample. We then use the count as an indicator of the overall microbial quality of a raw material.

Lactic Acid Bacteria Testing -Lactic Acid bacteria (probiotics) are tested for VITANOVA products by a pour plate method. Appropriate dilutions are prepared to obtain accurate results. The plates are placed in a GasPak jar and incubated for three days. The plate count is used to determine the potency of the probiotics.

Yeast and Mold Testing -we regularly perform yeast and mold counts by using an agar that contains the nutrients these organisms would need to sustain life if they were present. Raw materials with high mold counts are then tested for the presence of aflatoxins since some molds can produce these chemicals.

E. coli, Coliform, S. aureus Testing – we test raw materials for the presence of E. coli, Coliforms, and S. aureus using specially designed agars that contain an indicator that turns the bacteria blue (E. coli), pink (Coliforms), and dark pink (S. aureus) if present. This allows for visual identification of the bacteria.

Salmonella Testing - Since Salmonella can be present in botanical raw materials, we added that screening to our testing capabilities.

Analytical Instrumentation

Mid-Infrared Spectroscopy (FTIR) - Mid-Fourier Transform Infrared Spectroscopy validates the authenticity of a raw material. A beam of infrared light is passed through a sample of the raw material. As the beam shines on the sample, the sample absorbs energy from the beam at certain frequencies resulting in an absorption spectrum. No two chemical compounds have the exact same absorption spectrum, so by comparing these spectra to existing spectra, We can positively identify the raw material.

NIR Spectrometer - Near-infrared (NIR) is the region of light that is next to visible light and falls between the wavelengths of 750 and 3,000 nanometers. While Mid-IR spectra are the result of fundamental bands, NIR spectra are primarily the results of overtones. Since each fundamental band can have multiple overtones, NIR spectra are multifarious relative to Mid-IR spectra. Through the use of complex algorithms generated by highly advanced chemometrics software, this increased complexity allows for the distinction of very similar raw materials that would not be appropriately analyzed by Mid-IR. Once enough batches of a raw material have been identified by another method, a calibration curve is made which allows us to quickly and effectively identify that raw material. In conjunction with other techniques, our top of the line Buchi NIR enables us to accurately identify our raw materials in a relatively short period of time.

HPLC - These instruments allow us to examine the purity and potency of the non-volatile components of raw materials and finished products. A dissolved sample is placed into an auto sampler. The solution is injected into the system, and it is then pumped through an analytical column. The mixture separates into different vitamin or herb components, and the detector measures the amount of each component in the mixture relative to a standard. The computer generated HPLC plots are used to verify that the components are present in the appropriate ratio.

UPLC-MS - Though it works on the same principal as an HPLC, a UPLC (Ultra Performance Liquid Chromatography System) is really in a class of its own. It is capable of very short run times allowing many more analyses to be completed relative to an HPLC. The columns are designed to separate complex mixtures of components under very high pressure.There are two detectors associated with this system: PDA and MS. The PDA (Photodiode-Array) detector is the most powerful UV-Vis (Ultraviolet-Visible) detector in use today. It permits the rapid collection of UV-Vis spectra for each chromatographic peak. The MS (Mass Spectrometer) detector affords many advantages over other detectors including high sensitivity and selectivity both of which are extremely important in potency analyses. It also enables the user to gather structural information that can be used to further confirm the identities of components such as vitamins and impurities.

TLC - Thin Layer Chromatography (TLC) has many identification applications from botanical extracts and non-extracts to certain minerals. A sample in solution is applied to a plate coated with silica gel. The plate is developed in a mobile phase that separates the individual components of the mixture based on polarity. The patterns that are produced during an analysis can be compared to a standard to confirm the identity of a material.

HPTLC - High Performance Thin Layer Chromatography (HPTLC) is a step above normal methods of TLC. It allows for the separation of complex mixtures into well defined bands thus yielding chromatograms with much higher resolution than traditional TLC. Because of this, closely related materials can be differentiated with relative ease.

CAMAG HPTLC system - Our CAMAG HPTLC system includes a visualization module that affords GMP compliant documentation and the ability to do semi-quantitative as well as qualitative analyses. The software can be used to compare archived chromatograms side by side with current chromatograms. This system along with botanical reference materials, chemical markers, and compendial methods is a very powerful tool for the identification of botanical extracts and non-extracts as well as other materials and can be used for the semi-quantitative analyses of potential contaminants.

Atomic Absorption (AA) - This instrument allows us to analyze for minerals in a mixture. Acid digested samples are placed into the auto sampler and are then pumped through an acetylene flame. The detector measures the absorption of light at discreet wavelengths and the software converts the result into the amount of each mineral that is present.

ICP-MS -Our ICP-MS Inductively Coupled Plasma (ICP) Mass Spectrometry (MS) has become an important addition to the our testing procedures. The ICP produces elemental ions that are separated and detected by the MS. A collision cell removes interferences that could lead to falsely inflated results. This highly sensitive technique combined with microwave assisted digestion is able to detect and quantify elements over a vast concentration range. Though the primary use of this instrument is to screen for trace quantities of heavy metals and other elements, it has all but replaced Flame AA for the analysis of minerals as well.

GC-MS - Gas Chromatography Mass Spectrometry is the ultimate method for qualitative and quantitative analyses of pesticides and other volatile substances. A solution is injected into a chamber that converts the solvent and volatile components into a gas phase. A carrier gas (such as helium) forces the sample through a capillary column that separates the mixture into its individual components based upon their different chemical properties. The MS ionizes each chemical as it elutes and produces fragmented ions that are separated and detected according to their mass to charge ratio. The fragmentation pattern can be compared to a database (such as the NIST MS library) or to a standard for identification. The fragmentation pattern can also be used for structural elucidation of an unknown using the principles of molecular fragmentation.

UV-Vis Spectrophotometer -UV-Vis spectrophotometers measure the absorption of ultraviolet and visible light. A sample in solution is irradiated in the UV-Vis region and certain wavelengths are selectively absorbed at an intensity that is relative to the concentration of the substance in the solvent.

Many raw materials can be tested for potency using this instrument. It also allows us to confirm the concentration of our HPLC and UPLC-MS standards. Plus there are some identification techniques that utilize this instrument.

PPSL (Irradiated Food Screening System) - The FDA has banned the use of irradiation for the reduction of microbial loads in raw materials that are used to make dietary supplements except in specific cases. Some raw material vendors, however, continue to use this method of sterilization for unapproved materials. The data from our PPSL can be used to determine if a raw material has been treated by ionizing radiation (such as gamma rays). It works on the basis of detecting luminescence resulting from pulsed light (Pulsed Photo Stimulated Luminescence).

Other Capabilities

Organoleptic ID Testing - These analyses include testing with the senses, i.e. checking the taste, odor, color, and appearance of the raw material. This kind of testing is an important part of identity testing for some raw materials and ensures a consistent color for finished products.

Botanical Microscopy - Botanical Microscopy is a well established method of identifying whole and ground botanical raw materials. In this technique, an analyst examines the cellular structures of a plant and compares the observed structures to a scientific reference or to a standard sample.

Stability Studies - Accelerated stability studies are done to determine the shelf life of products based on analytical and microbiological data. Products are placed in the stability chamber in full packaging and are tested at monthly intervals to determine potency of active ingredients. Based on these data, appropriate shelf lives can be established.



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