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Quality

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From Start to Finish.

From Raw Materials to Finished Goods

Every step of the way!

Quality is of utmost importance to EverLife and ensuring that premium quality is a round the clock practice. That is why each of our raw materials are rigorously tested to ensure identity, authenticity, and potency. In addition to those establishing those parameters we also perform stringent tests for contaminants. EverLife products are manufactured in a Natural Products Association Good Manufacturing Practices (GMP) facility.  We follow the most demanding FDA standards to ensure you receive the highest quality product.


Natural Products Association: GMP Certified Facility

    • Our products are manufactured in a Natural Products Association approved facility and as a result follow its rigorous code of ethics.
    • Our manufacturing partners are certified for current Good Manufacturing Practices (cGMPs) by the Natural Products Association
    • Dietary supplements are manufactured in full compliance with 21 CFR 210 in the Code of Federal Regulations, which ensure quality controls throughout all processing
    • Our manufacturing partners are inspected by the FDA for Pharmaceutical Manufacturing
    • Our manufacturing partners are licensed through the California Department of Health Services for Drug Manufacturing and Processed Manufacturing (required of food supplement manufacturers)


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 Adherence to current Good Manufacturing Practices (cGMPs)

    • Complete raw material sampling, including identification, analysis and release to predetermined specifications
    • Microbiological analysis to ensure it meets specifications for levels of harmful salmonella, E coli, yeast and molds
    • Inspection of rooms and equipment to be used in blending, milling, drying and coating
    • Sign off procedure prior to start of all processes
    • Double check weighing system of all ingredients to eliminate mixing errors
    • Computer recording of weights, eliminating human error
    • Testing for hardness, thickness and friability at half-hour intervals to ensure uniformity
    • Chronological sequence tracking in each step of production to provide a reference record for any possible problems
    • Finished product sample analysis from production line
    • Sample retention from all batches for one year after Best By date
    • Amber colored recyclable glass bottles preserve freshness
    • Labels list all ingredients to avoid consumer allergic reactions to unnamed ingredients
    • Best By dates guarantee freshness
    • Full body, tamper-evident sleeves ensure consumer safety

 
Why is quality important?

    • Is your supplement manufacture ensuring quality raw materials are used in production?
    • Are the raw materials used in manufacturing of your supplements tested thoroughly before going into production?
    • Is your dietary supplement solution compliant with all federally regulated current Good Manufacturing Practices?
    • Is your dietary supplement provider investing in its own Quality Assurance and Quality Control operations?
    • Is your dietary supplement attaining additional third party certifications with increasingly stringent standards?
    • Does your dietary supplement solution invest in systematic Quality Systems such as analytical instrumentation, cross-contamination control, metal detection, x-ray systems, new cutting edge manufacturing equipment, and Enterprise Resource Planning?
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Independent laboratories have demonstrated that quality systems are lacking throughout the dietary and vitamin supplement industry!
    • Raw materials may not be tested effectively and therefore may be sub-potent, contaminated, adulterated, misbranded, and or may contain foreign material
    • Products may be manufactured outside the United States where laboratory sampling, test methodology, and calibration may not as stringent as US standards.
    • Pricing pressure can result in supplier shortcuts, which may lead to sub potent, diluted, or adulterated raw materials.
    • Potential batch to batch consistency and uniformity issues may occur between production runs.




QUALITY PROCESS:

Quality Control and Quality Assurance are on-going processes that start with raw material sourcing, continue throughout manufacturing, packaging, and shipping.

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QUALITY ANALYTICAL INSTRUMENTATION AND METHODS:
 

MICROBIOLOGICAL TESTING
 

Total Plate Count Testing
Total Plate Count or TPC is used to determine the number of microbes that might be contaminating a product. 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.

 

Yeast and Mold Testing
Yeast and Mold counts are assessed by using a microbial culture medium that contains specific nutrients for these organism. This allows for visual identification of the bacteria. Raw materials with high mold counts are then tested for the presence of aflatoxins. 

 

E. coli, Coliform, and S. aureus Testing
We perform tests on 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 have added that screening to our in-house capabilities. This has eliminated the need to use costly and time consuming contract laboratories for this test.


Lactic Acid Bacteria Testing
Lactic Acid bacteria (probiotics) are tested 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.

 

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 chemo-metrics 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.


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.


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. 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.


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.


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.


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 - Inductively Coupled Plasma (ICP) Mass Spectrometry (MS)
has become an important addition to the laboratory. 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 UPLCMS 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).

  

ADDITIONAL CAPABILITIES


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.


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.


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.


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