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MRL Quality Control Standards. Raw Material Quality Control The raw material cultivation processes are certified organic by QAI as in accordance with: the Organic Foods Production Act of 1990 and 7 CRF Part 205 the QAI EU Program and EU Council Regulation (EEC) No. 2092/91).

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MRL Quality Control Standards

Raw Material Quality Control

The raw material cultivation processes are certified organic by QAI as in accordance with:

the Organic Foods Production Act of 1990 and 7 CRF Part 205

the QAI EU Program and EU Council Regulation (EEC) No. 2092/91).

This aspect is important when:

in some countries mushroom cultivation is not advanced; thereby raw material may have either heavy metal or E. Coli contamination.

some producers have mislabelled Cordyceps militarium as Cordyceps sinensis.


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Production

  • Substrate Dispensed to Micropore Filtered Container (<0.1 micron)

  • Steam Sterilized at 121ºC for 1 hour

  • Temperature Verified by Calibrated Probe


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Inoculation

  • Substrate Cooled to Target Temperature in 99.7% DOP HEPA-Filtered Air

  • Inoculated with Pure Culture Under Aseptic Conditions

  • Hermetically Sealed


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Incubation

  • Controlled Environmental Conditions

  • Regularly Inspected

  • Standardized Incubation Period

  • Documented Harvesting Stage


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Drying

  • Room Under Positive Pressure by 99.7% HEPA Filter

  • Low Drying Temperature

  • Moisture Content Monitored to Determine Completion of Drying


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Granulation

  • Processed in 99.7% DOP HEPA-Filtered Air

  • Controlled Feed Rate to Keep Equipment Temperatures Low

  • Granulated Product is Bagged with Desiccant and Stored in Sealed Buckets


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Quality Control

  • Microbiologically Testing

    • Aerobic Bacteria

    • Yeast & Mold

    • E. coli and Total Coliforms

  • Independently Verified


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MRL Quality Control Standards

  • Finished Product Quality Control

  • Granulated mushroom powder arrives in Holland or Italy with Certificate of Analysis supplied by raw material manufacturer.

  • HACCP (Food Grade) EU Manufacturers review Certificate of Analysis.

    • Prior to 500 mg tablet manufacturing

      • Cytogenex Ltd using PCR DNA testing techniques verifies mushroom strain

      • Cytogenex Ltd conducts TVAC testing of powder

    • Upon completion of tablet manufacturing

      • Cytogenex Ltd. conducts TVAC testing of tablets.


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