MRL Quality Control Standards Raw Material Quality Control
- Slides: 8
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 121ºC for 1 hour Temperature Verified by Calibrated Probe
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
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 Equipment Temperatures Low Granulated Product is Bagged with Desiccant and Stored in Sealed Buckets
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 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.