Three Treasures Quality Assurance
24th Jun 2022
THREE TREASURES, WOMEN'S TREASURES, AND LITTLE TREASURES FORMULAS
Quality Controls
The Three Treasures®, Women’s Treasure™ and Little Treasures® are made to the highest manufacturing standards in three manufacturing facilities, two in the United States and the other in the European Union. For reference, the formulae contain:
- No Aristolochic acids;
- No Hydrogenated oils;
- No magnesium stearate;
- No animal products;
- No heavy metals;
- No contaminants;
- No shellfish;
- No minerals;
- No toxic herbs or banned herbs.
The formulae are produced using only fully authenticated concentrated herbal powders, made from raw herbs sourced from suppliers adhering to Good Agricultural Practices (GAP) and processed in environmentally controlled facilities.
The herbs undergo strict identification protocols, for conformity and species verification, by experienced botanists, including i)Thin-Layer Chromatography (TLC) identification, which confirms herb identity by using a chemical fingerprint unique to each species, and ii) High Performance Liquid Chromatography (HPLC), which measures potency by substantiating the presence of active ingredients.
The analyses must comply with monographs of the European Pharmacopoeia that meets the latest scientific standards.
Each herbal extract undergos a stringent microbial examination (for example, salmonella, col-bacteria and a total bacteria count), moulds and yeasts.
Gas Chromatography (GC) further ensures safety by testing for over 200 potentially harmful substances such as pesticides, bio-burden, herbicides and fungicides. Herbs susceptible to contamination by aflatoxins, aristolochic acid, mycotoxins, polyaromatic hydrocarbons (PAH’s) and pyrrolizidin alkaloids (PA’s) are tested separately.
Post production microbe tests are also carried out using Method USP 2021 & 2022.
The analysis of heavy metal values (in compliance with US EPA SW-846 Method 3051) uses a process called Inductively Coupled Plasma-Mass Spectrometry (ICP-MS), which is a state-of-the-art geophysical technology that ensures absolute safety of each herbal extract, with reference to the limit values of the European pharmacopeia. This system is sensitive to sub-parts per billion.
The manufacturing facilities in California and Oregon, United States, meet with FDA current current Good Manufacturing Practices. It benefits from state-of-the-art equipment and is TAF and ISO certified. Advanced extraction and concentration equipment decocts and extracts active ingredients from the herbs, using a liquid nitrogen freezing process, to grind the herbs with high viscosity and oil to maintain their natural characteristics.
Our manufacturing facility in the Netherlands, in the European Union, meets the latest standards in terms of production, legislation, and certification following the quality systems HACCP Plus, Z-GMP (this is hospital pharmacy GMP), HKZ, NAN (Dutch for Good Pharmacy Practice) and FSSC22000.
All of the herbs for a single formula are decocted separately, so individual herbal quality is optimized. The herbs undergo several further processes to create the finished product, including: i) evaporation, ii) the re-introduction of the collected volatile oils, iii) further concentration of the liquid extract, and finally iv) granulation, during which the concentrate is sprayed onto starch particles of the same herbs and is vacuum-dried at a low temperature. This takes place in a completely enclosed chamber to protect against cross-contamination.
During the final process of formulation, the modified formulae, now in their dry granular form, undergo tableting, which are bottled and sealed to GMP standards.
The average weight, the weight variation, the hardness of the tablets, the solubility and stability of the tablets are also tested. After processing, each batch of every product is subject to a detailed and careful analysis to ensure a consistent and stable product, in compliance with Good Pharmacy Practices.
The final products come complete with a certificate of analysis, which lists the botanical name of the herb and its organoleptic properties, all test results and relevant information. To request a copy of the certificate of analysis for any formula please contact us.