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MRL Quality Control Standards

This document outlines the stringent quality control standards for organic raw mushroom material cultivation, certified by QAI under the Organic Foods Production Act. Key procedures discussed include substrate sterilization, aseptic inoculation, and controlled environmental conditions, all designed to prevent contamination. Emphasis is placed on the importance of proper identification of mushroom strains and thorough microbiological testing of raw materials and finished products. The final product receives independent verification with Certificates of Analysis, ensuring quality and safety prior to tablet manufacturing.

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MRL Quality Control Standards

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  1. 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.

  2. Production • Substrate Dispensed to Micropore Filtered Container (<0.1 micron) • Steam Sterilized at 121ºC for 1 hour • Temperature Verified by Calibrated Probe

  3. Inoculation • Substrate Cooled to Target Temperature in 99.7% DOP HEPA-Filtered Air • Inoculated with Pure Culture Under Aseptic Conditions • Hermetically Sealed

  4. Incubation • Controlled Environmental Conditions • Regularly Inspected • Standardized Incubation Period • Documented Harvesting Stage

  5. Drying • Room Under Positive Pressure by 99.7% HEPA Filter • Low Drying Temperature • Moisture Content Monitored to Determine Completion of Drying

  6. 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

  7. Quality Control • Microbiologically Testing • Aerobic Bacteria • Yeast & Mold • E. coli and Total Coliforms • Independently Verified

  8. 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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