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Quality System 2017-03-29T21:39:03+00:00

For thousands of years, herbs have been used, studied, and celebrated for their therapeutic properties. Yet, the rapid industrialization over the past two centuries has dramatically changed the natural environment and the methods for the cultivation of herbs. Long ago, herbs were cultivated organically because of a lack of industrial means. Industry has greatly increased the productivity of farmers, but herbs now face threats to their safety and integrity from exposure to chemicals and industrial runoff. This includes industrial waste released into the environment and the chemical pesticides and fertilizers used by farmers to promote better yields.

Novoherb’s top priority is guarding against these threats and ensuring the safety of our herbal products. Herbs and Herbal Extracts’ Quality Standards including: the herb’s exterior, color and grain, taste, odor, mesh size, density, solubility, qualitative and quantitative analysis for bioactive components/maker compounds, loss on drying, residue on ignition, heavy metal, pesticide residue, microbiological analysis, identification for possible adulteration content, etc. In order to comply with that strict quality standard, Novoherb set up Standard Operation Procedure (SOP) at each stage. Only batches that passed through our rigorous testing standards and inspection processes can be released.

A. Raw Materials SOP
The raw materials’ quality vary a lot based upon their variety, growing conditions, growth age, used party, preparation method, stock conditions, etc., it all affect the bioactive components in it. In order to ensure a consistent and stable extracts quality, it’s essential to normalized Raw Materials SOP. Key points including:

(a). Species Authentication:
Authentication is the determination of the correct species, origin and quality of Chinese herbs. Novoherb’s authentication process aims to prevent the use of inauthentic herbs, whether by mistaken identification or the substitution of imitation products.

Novoherb performs the following methods of authentication on raw herbs:

• Appearance
• Microscopic Analysis
• Physical/Chemical Identification
• Chemical Fingerprint Technology

(b). Growing Conditions
TCM herbalism emphasizes Di Dao theory throughout. Dao Di herb has been defined as premium herb for being produced in specific geographic regions with particular attention to cultivation and processing techniques since Tang Dynasty (618 – 907 C.E.) for long history, such as Bai Shao (Bai Shao/White Peony of Bozhou), Huai Di Huang (Di Huang/Rehmannia of ancient huaiqing, Henan), Ningxia Gou Qi (Gou Qi/Lycium Fruit of Ningxia).

(c). Growth Age & Used Party
Herbs that being collected before mature can cause low quality largely. Such as Astragalus, traditionally the best one should bearound 5~6 years old with a diameter of 2~3cm, and the used party is root. Herbs using it’s barks such as Eucommia should be around 10~15 years old with thickness of 3~6cm.

(d). Hygienic Security
Each batch of herbs should go through strict hygienic security testing before go ahead. Novoherb takes a comprehensive testing approach including:

• Sulfur Dioxide Detection
• Pesticide Residuals Detection
• Aflatoxin Detection
• Heavy Metal

B. Extraction Process SOP
Unlike synthetic chemicals/drugs, the composition in herbs is far more complex, therefore herbal extracts are usually the mixture of one or several categories of components. It’s the herbal extracts’ multi-components characteristic determines it’s pharmacologic action’s multiple target point, thus to keep human body in a balanced health as a whole. It’s obviously unreasonable to judge the quality by a certain maker compound. The mission of Extraction Process SOP is to maintain such comprehensive quality stability. Key points including:

(a). Herbal Preparation
Once the best herbs are selected, they are cleaned and prepared according to a protocol customized for that herb. Dirt and other foreign materials are meticulously removed, and the herbs are then sliced or prepared with traditional pao zhi methods before being extracted.

Different Pao Zhi Methods (preparation methods) can make herb quality vary a lot.

(b). Extraction & Concentration
Different herbs may have different characteristic and thus should take different extraction process. For most herbs we only use the purified water as extraction solvent. The precise extraction temperature and timing are unique to each herb and strictly controlled. Especially for herbs that contains heat sensitive components, low-temperature process can preserve the potency of the herbal extract’s potency that would otherwise damaged under extended exposure to high temperatures.

(c). Essential Oil Restoration
One very important process that most factories skip involves the collection of aromatic oils from herbs, which are usually the bioactive components. Novoherb’s patented essential oil retrieval system using an “oil trap” connected to the extraction system to capture and preserve the volatile oils. They are blended back into the extracts at the end of the process. Essential oils increase efficacy and infuse the herbs with their natural aroma.

(d). Spray-Drying
The concentrated liquid extracts are dried by using an ultra high speed spray dryer. During this process, the liquid herbal concentration is automized into fine droplets, which are thrown radially into a moving stream of hot gas. The temperature of the droplets is immediately increases and fine droplets get dried instantaneously in the spherical particles. The whole drying process completes in a few seconds and maximally remain herbal potency.

And, for spray drying process, heat and mass transfer during drying occurs in the air and vapor films surrounding the droplet. This protective envelope of vapor keeps the particle at the saturation temperature. As long as the particle does not become “bone-dry”, evaporation is still taking place and the temperature of the solids will not approach the dryer outlet temperature. This is why many heat sensitive products can be spray dried easily at relatively high inlet temperatures.

C. Finished Product Testing SOP
Testing result can be different due to different testing method, equipments, and sample preparation, etc. Thus standard testing procedure is necessary to get a consistent results for herbal extracts.

High-precision laboratory tests check multiple samples from each batch to measure the potency and to establish the safety of the product. These tests include the following:

• UV/HPLC/UPLC-MS-MS to measure key bioactive ingredients.
• FFETTM (Fingerprint Full-Spectrum Extract Technology) to judge extract’s inherent quality
• AAS/ICP-MS to test heavy metals.
• GC-MS-MS to ensure safety by testing for the presence of pesticide residuals.
• Microbiological assays to screen for E. coli, salmonella and various other possible bio-contaminants such as molds or yeasts