Processes

Collection

Cultivation makes the difference

The proper identification, quality and the consistency of the starting herbal material is an essential and important requirement for any downstream extraction process. Several different measures are followed to ensure the quality and characteristics of our botanical raw materials. Only upon satisfactory tests and conformation the raw materials are released for further processing. Our conformation check includes:

  1. Cultivar seed selection and planting materials

  2. Location, farm and farmer selection, inspection and qualification, according to GAP (Good Agricultural Practices)

  3. Confirmation of harvesting time, conditions and methods

  4. Confirmation of drying and storage conditions

  5. Chemical analysis and identification of plant raw materials

  6. Microbiological, heavy metals, aflatoxins and contaminants analysis

Creation

Critical check & stringent controls

The manufacturing and downstream processing is controlled by strict adherence to GMP standards with well defined standard operation procedures (SOP) which includes analysis at critical points of processing. All raw data is recorded, every critical procedure and parameter is thoroughly described for workers and double-checked in a Process Data Sheet (PDS) and available for every batch of production. All the manufacturing procedures and critical points as per below are documented:

  1. Pulverizing or grinding of raw botanicals

  2. Extraction process conformation parameters including solvent type, conditions (time, temperature and pressure)

  3. Concentration methods and conditions

  4. Purification process and conditions

  5. Drying, milling and sieving conditions

  6. Packaging and labeling parameters and conformation

Conformation

Assuring Quality

The final product next undergoes complete analysis and production documentation review and conformation as per our stringent Quality Assurance and Quality Check, ensuring compliance with specifications. State of the art and high end technology and analytical instrumentation including HPLC and NMR systems are used to confirm product quality. Results are reproduced and provided on Certificate of Analysis for every lot production. This stage involves quality assurance/quality control testing as below:

  1. Physical properties

  2. Solubility Profiling

  3. Active compounds

  4. Impurity Profiling

  5. Heavy Metals

  6. Pesticides

  7. Microbiological analysis

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