CARR ViaFuge Technology

Transcription

1 CARR ViaFuge Technology

2 CARR ViaFuge Based on proven Powerfuge technology Scalable solution TrueClean TM design new SoftStream TM feed design Enabling Cell Harvest Technology Recovery of viable, intact cells (>99%) High concentration factors (up to 50X) Mammalian, Insect, Plant cells

3 Proven Applications CHO Cells Human Lymphocytes sf9 Insect Cells Rat Myeloma More

4 ViaFuge Pilot Specifications Maximum flow rate 240L/h Maximum G-force: Bowl capacity 1,3L USP Class VI Elastomers SIP at 2 bar (ASME rated) Double Mechanical Gas Purge Seal 316L Stainless steel case Surface Finish <25 Ra Titanium Bowl

5 Pilot Process Flow Cell free supernatant is discharged at atmospheric pressure Cells concentrate at the bowl wall Cell Concentrate is recovered by reversing the pump after the bowl fills Unique Low shear feed design & low G forces assures no cell damage.

6 ViaFuge V12 Specifications Speed range RPM (5.000 x g) Maximum flow rate L/h Bowl capacity 16,7L USP Class VI Elastomers 316L Stainless steel case Surface Finish <25 Ra Titanium Bowl Double Mechanical Gas Purge Seal Automated CIP Included Manual SIP Included (ASME Vessel) Automated SIP Available

7 V12 Process Flow Cell Concentrate is recovered by decelerating the bowl once it fills Feed is introduced at zero g-force into an Elliptical Accelerator Clarified supernatant flows towards the Core Cells are gently accelerated up to the set g-force & concentrated at the Bowl Wall Once the bowl stops, the cell slurry collects in an Annulus then to the Concentrate Outlet Feed Inlet Clarified supernatant is continuously collected from the Centrate Outlet

8 cgmp Compliance True Clean TM Design Sanitary Design CIP SIP Automation Processing, Solids Removal, CIP/SIP Closed System Processing cgmp Documentation

9 True Clean TM Design - CIP Requires Sanitary Design All process wetted components 100% CIP Access Reproducible CIP Process Verification Riboflavin testing

10 CIP Design Sanitary Design of equipment CIP Spray balls are strategically located throughout the pressure boundary Feed tube incorporates an outer tube for CIP fluid via jets CIP coverage in bowl area via feed path Base configuration incorporates automatic CIP valves 4 Wash Zones Vent Line Wash (Not Shown) Bowl Case Wash Bowl Wash Main Feed Wash

11 CIP Validation - Riboflavin Test Clean-in-Place challenge conducted on the ViaFuge V12 with automated CIP All direct and indirect process contact surfaces sprayed with riboflavin/dextrose solution (50mg/L / 10wt%), dried overnight Automated CIP cycle was performed using only cold tap water as a cleaning agent The unit was inspected after cleaning by UV light Acceptance Total wash cycle was 50 minutes Analysis of the unit under Ultraviolet Light revealed no trace of residual riboflavin after the worst case scenario wash regime Testing with ancillary equipment also met TrueClean specifications

12 V12 - SIP Validation Spore Strips Placed throughout V12 30 minute >121 C Removed, inoculated in soy broth medium at 55 C for 7 days Temperature Mapping Thermocouples placed at low temperature points

13 Spore Studies SIP Test Results No growth was observed in any inoculated steam sterilized spore strips Temperature Mapping Viafuge V12 30 minute sterilization Temperature 140 C 120 C 100 C 80 C 60 C 40 C 20 C 0 C Time (min.) TC1 Temp. ( C) TC2 Temp. ( C) TC3 Temp. ( C) TC4 Temp. ( C) Time Elapsed (min.) TC1 Temp. ( C) TC2 Temp. ( C) TC3 Temp. ( C) TC4 Temp. ( C)

14 cgmp Documentation Material Traceability Material certificates and test reports Weld reports and inspection reports In-Coming Materials Vendor qualification and auditing 100% inspection of fabricated and critical components Documentation Documentation of System Configuration Complete documentation control & file management Engineering change order and customer approval process Final test report and procedures Operating manuals and engineering drawings

15 CARR ViaFuge - Summary Based on proven Powerfuge Technology Automated Processing Scalable Solutions (up to L/h) TrueClean design Specifically designed for intact, viable recovery of shear sensitive cells