MRL Quality Control Standards

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
  militaris as Cordyceps sinensis.

2
Production

• Substrate Dispensed to Micropore Filtered
  Container (lt0.1 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
• Coliform
• Enterobacteria
• 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.