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MRL Quality Control MRL Quality Control StandardsStandards
Raw Material Quality ControlThe 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.
ProductionProduction
Substrate Dispensed to Micropore Filtered Container (<0.1 micron)
Steam Sterilized at 121ºC for 1 hour
Temperature Verified by Calibrated Probe
InoculationInoculation
Substrate Cooled to Target Temperature in 99.7% DOP HEPA-Filtered Air
Inoculated with Pure Culture Under Aseptic Conditions
Hermetically Sealed
IncubationIncubation
Controlled Environmental Conditions
Regularly Inspected Standardized Incubation
Period Documented Harvesting
Stage
DryingDrying Room Under Positive
Pressure by 99.7% HEPA Filter
Low Drying Temperature
Moisture Content Monitored to Determine Completion of Drying
GranulationGranulation 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 ControlQuality Control Microbiologically Testing
• Aerobic Bacteria• Yeast & Mold• E. coli and Total
Coliforms
Independently Verified
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.
MRL Quality Control MRL Quality Control StandardsStandards