Transcript MRL Quality Control Processes

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 militaris as Cordyceps sinensis.
Production
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Substrate Dispensed to
Micropore
Filtered
Container (<0.1 micron)
Steam Sterilized at 121ºC
for 1 hour
Temperature Verified by
Calibrated Probe
Inoculation
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Substrate Cooled to Target
Temperature in 99.7% DOP
HEPA-Filtered Air
Inoculated
with
Pure
Culture Under Aseptic
Conditions
Hermetically Sealed
Incubation
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Controlled
Environmental
Conditions
Regularly Inspected
Standardized Incubation Period
Documented Harvesting Stage
Drying
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Room
Under
Positive
Pressure by 99.7% HEPA
Filter
Low Drying Temperature
Moisture
Content
Monitored to Determine
Completion of Drying
Granulation
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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
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Microbiologically Testing
• Aerobic Bacteria
• Yeast & Mold
• E. Coli
• Coliform
• Enterobacteria
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Independently Verified
MRL Quality Control Standards
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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.