MRL Quality Control Standards Raw Material Quality Control

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MRL Quality Control Standards Raw Material Quality Control The raw material cultivation processes are

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.

Production n Substrate Dispensed to Micropore Filtered Container (<0. 1 micron) Steam Sterilized at

Production n Substrate Dispensed to Micropore Filtered Container (<0. 1 micron) Steam Sterilized at 121ºC for 1 hour Temperature Verified by Calibrated Probe

Inoculation n Substrate Cooled to Target Temperature in 99. 7% DOP HEPAFiltered Air Inoculated

Inoculation n Substrate Cooled to Target Temperature in 99. 7% DOP HEPAFiltered Air Inoculated with Pure Culture Under Aseptic Conditions Hermetically Sealed

Incubation n n Controlled Environmental Conditions Regularly Inspected Standardized Incubation Period Documented Harvesting Stage

Incubation n n Controlled Environmental Conditions Regularly Inspected Standardized Incubation Period Documented Harvesting Stage

Drying n n n Room Under Positive Pressure by 99. 7% HEPA Filter Low

Drying n n n Room Under Positive Pressure by 99. 7% HEPA Filter Low Drying Temperature Moisture Content Monitored to Determine Completion of Drying

Granulation n Processed in 99. 7% DOP HEPA-Filtered Air Controlled Feed Rate to Keep

Granulation n 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

Quality Control n Microbiologically Testing • Aerobic Bacteria • Yeast & Mold • E.

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

MRL Quality Control Standards n n n Finished Product Quality Control Granulated mushroom powder

MRL Quality Control Standards n n n 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.