Xvivo System model X2 —  The 21st Century GMP Quality Platform for processing and producing clinical grade cells.

Full Time Aseptic Processing

 

•  Closed means zero-CFU is minimal expectation

 

•  Air and room quality outside doesn’t matter

EVIDENCE-BASED ZERO CFUs

 

No opinions. No beliefs. No dogma. No superstition. No tradition. Just hard-core reproducible evidence.

 

Quality recognizes that every entire cell production line (all manual and automated steps) must be protected from microbial contamination by full-time aseptic conditions (zero CFU) instead of part-time by semi-aseptic (low CFU). The Cytocentric X2 Platform does this now.

ASEPTIC PRODUCTION “TUNNEL” IS FITTED AROUND ENTIRE PRODUCT FLOW FROM BEGINNING TO END

 

Metabolizing cells are found in only 4 places outside the body. Whether incubating, being processed or analyzed in machines, being handled, or being transported between any two, closed is the key to aseptic cell production.

CELLS OUTSIDE THE BODY

INCUBATION

• C02 Incubator
• 02/C02 Incubator
• Thermal Incubator
• Bioreactor
• etc.

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HANDLING

• BSL2 Hood
• Laminar Clean Hood
• Glove Box
• Lab Bench
• etc.

MACHINES

• Microscope
• Sorter
• Separator
• Reader
• Centrifuge
• Mixer
• Analyzer
• Robot
• etc.

TRANSPORT

• Incubator to Hood
• Hood to Incubator
• Hood to Machine
• Machine to Incubator
• etc.

CELLS OUTSIDE THE BODY

LOW RISK INCUBATION

 

Incubators open only into closed aseptic processing chamber with no people and no room air in the same space as cells. Technician can cough, sneeze, even spray sputum aerosols toward cells with no risk of contamination.

HIGH RISK INCUBATION

 

Incubators open into room with people and HVAC air in the same space as cells.  Minimally acceptable cGMP.

CELLS OUTSIDE THE BODY

INCUBATION

• C02 Incubator
• 02/C02 Incubator
• Thermal Incubator
• Bioreactor
• etc.

HANDLING

• BSL2 Hood
• Laminar Clean Hood
• Glove Box
• Lab Bench
• etc.

biospherixmedical_chart_arrow

MACHINES

• Microscope
• Sorter
• Separator
• Reader
• Centrifuge
• Mixer
• Analyzer
• Robot
• etc.

TRANSPORT

• Incubator to Hood
• Hood to Incubator
• Hood to Machine
• Machine to Incubator
• etc.

CELLS OUTSIDE THE BODY

LOW RISK HANDLING

 

Closed with no people and no room air in the same space as cells. Technician can cough, sneeze, even spray sputum aerosols toward cells with no risk of contamination, yet not widely appreciated.

HIGH RISK HANDLING

 

Open with people and room air in the same space as cells, yet minimally acceptable.

CELLS OUTSIDE THE BODY

INCUBATION

• C02 Incubator
• 02/C02 Incubator
• Thermal Incubator
• Bioreactor
• etc.

HANDLING

• BSL2 Hood
• Laminar Clean Hood
• Glove Box
• Lab Bench
• etc.

MACHINES

• Microscope
• Sorter
• Separator
• Reader
• Centrifuge
• Mixer
• Analyzer
• Robot
• etc.

biospherixmedical_chart_arrow

TRANSPORT

• Incubator to Hood
• Hood to Incubator
• Hood to Machine
• Machine to Incubator
• etc.

CELLS OUTSIDE THE BODY

LOW RISK MACHINE PROCESSING

 

Closed with no people and no room air in the same space as cell processing machine and cells. With no effort, machine stays clean and cells never get contaminated, yet not widely appreciated.

HIGH RISK MACHINE PROCESSING

 

Open with people and room air in the same space as cells and machine, yet minimally acceptable.

CELLS OUTSIDE THE BODY

INCUBATION

• C02 Incubator
• 02/C02 Incubator
• Thermal Incubator
• Bioreactor
• etc.

HANDLING

• BSL2 Hood
• Laminar Clean Hood
• Glove Box
• Lab Bench
• etc.

MACHINES

• Microscope
• Sorter
• Separator
• Reader
• Centrifuge
• Mixer
• Analyzer
• Robot
• etc.

TRANSPORT

• Incubator to Hood
• Hood to Incubator
• Hood to Machine
• Machine to Incubator
• etc.

biospherixmedical_chart_arrow

CELLS OUTSIDE THE BODY

LOW RISK CELL TRANSPORT

 

Closed with no people and no room air in the same space as cells. Technician can cough, sneeze, even spray sputum aerosols toward cells with no risk of contamination, yet not widely appreciated.

HIGH RISK CELL TRANSPORT

 

Open with people and room air in the same space as cells, yet minimally acceptable.

Quality recognizes that zero CFU must be easily maintained regardless of air quality of the room, including unclassified clinical settings. The Cytocentric X2 Platform does this now.

EVIDENCE: Regardless of Conditions Outside Xvivo System, Inside is always ISO-5/Grade A or better.

 

Quality recognizes that zero CFU must be reliably maintained by low-skill production technicians.  The Cytocentric X2 Platform does this now.

COMPARATIVE RISK ASSESSMENT: Regulatory agencies understand it. Live cell industry doesn’t.

CONTAMINATION RISKXVIVO GMP+OPEN cGMP
Room Air
Technicians
Surface
Sample

COMPARATIVE RISK ASSESSMENT: Regulatory agencies understand it. Live cell industry doesn’t.

PRETTY LITTLE SECRET: One risk – surfaces of materials going in.

CONTAMINATION RISKXVIVO GMP+OPEN cGMP
Room Air
Technicians
Surface

PRETTY LITTLE SECRET: One risk – surfaces of materials going in.

SURFACE CONTAMINATION RISK MITIGATION

MULTIPLE REDUNDANT CONTROL POINTS

1. DECON WASH HANDS & GLOVE UP (decon wipe gloves).

2. STAGE MATERIAL NEAR LAMINAR HOOD

3. PREP LAMINAR HOOD (decon wipe floor of hood and gloves)

4. RE-STAGE MATERIAL INTO FRONT OF HOOD

5. MATERIAL PREP & RE-STAGE (TRANSFER) INTO REAR OF LAMINAR (debag, decon wipe all surfaces of all materials)

6. PREP BUFFER CHAMBER (decon wipe knob and floor)

7. MATERIAL TRANSFER INTO BUFFER AND CLOSE

8. WAIT FOR DF (detached microbes will be cleared in 10 mins)

9. PREP PROCESSING CHAMBER (decon wipe fixed gloves/overgloves, floor, buffer knob)

10. MATERIAL TRANSFER INTO PROCESS CHAMBER (decon wipe bottom surface of materials)

11. WAIT CRAC AND/OR DF (detached microbes will be cleared in 10 min)

12. PROCESS CULTURES

13. WAIT CRAC (detached microbes and aerosols will be cleared in 10 min)

14. TRANSFER CULTURES INTO INCUBATOR (decon wipe incubator door knob and front edge of sliding tray)

PROCESS CHAMBERS: MULTIPLE REDUNDANT CONTROL POINTS

RISK MITIGATIONREACH SURFACEUNREACH SURFACESEAMS, CREVICEGAS PHASE
Fumigate log 6 spore
Fumigate log 3 risk flora
Wipe Probable Risk
Wipe Improbable Risk
Ventilation (DF log 3-6)
CRAC HEPA
Dessication
UVc Wand (3rd party)

PROCESS CHAMBERS: MULTIPLE REDUNDANT CONTROL POINTS

INCUBATION CHAMBERS: MULTIPLE REDUNDANT CONTROL POINTS

RISK MITIGATIONREACH SURFACEUNREACH SURFACESEAMS, CREVICEGAS PHASE
Fumigate log 6 spore
Fumigate log 3 risk flora
Wipe Probable Risk
Wipe Improbable Risk
Ventilation (DF log 3-6)
Microbicidal water bath
Microbicidal interior
Autoclave rack, shelves

INCUBATION CHAMBERS: MULTIPLE REDUNDANT CONTROL POINTS

BUFFER CHAMBERS: MULTIPLE REDUNDANT CONTROL POINTS

RISK MITIGATIONREACH SURFACEUNREACH SURFACESEAMS, CREVICEGAS PHASE
Fumigate log 6 spore
Fumigate log 3 risk flora
Wipe Probable Risk
Wipe Improbable Risk
Ventilation (DF log 3-6)
Dessication
UVc Wand (3rd party)

BUFFER CHAMBERS: MULTIPLE REDUNDANT CONTROL POINTS

LOW RISK CELL THERAPY MANUFACTURING

 

No people and no room air are ever in the same space as clinical grade cells.

HIGH RISK CELL THERAPY MANUFACTURING

 

People and room air are always in the same space as clinical grade cells. It doesn’t make sense, but people-centric never does when it comes to cells. It’s minimally acceptable, until something better like Cytocentric comes along.