single use systems for aseptic fill finish - facility ... use... · single use formulation and...
TRANSCRIPT
![Page 1: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/1.jpg)
Single Use SystemsFor Aseptic Fill Finish–Facility Design Considerations11th June 2015
Hugh Hodkinson - DPS
![Page 2: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/2.jpg)
Introduction
• My Background
• What’s this lecture about?
• What should you get out of it?
![Page 3: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/3.jpg)
Benefits of Single Use Technology
• Flexibility
• Minimise cross contamination
• Reduce utility demand
![Page 4: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/4.jpg)
Case Studies
![Page 5: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/5.jpg)
Case Study 1:
Single Use Formulation for a High Potency Fill Finish Product
![Page 6: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/6.jpg)
Case Study 1:
Single Use Formulation for a High Potency Fill Finish Product
The Challenge
• Highly toxic product
• Small batch size
• Dedicated facility
• Budget Constraint
The Solution
• Disposable Carboy Mated with Isolator for Formulation
• Gamma Irradiated Filtration Assembly
![Page 7: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/7.jpg)
Case Study 1
Single Use Formulation for a High Potency Fill Finish Product
Pro’s
• No CIP Skids or COP/SOP Stations
• Low Utility Usage
• Simple Formulation Suite
• Cost effective
Con’s
• Difficult to facilitate future products
![Page 8: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/8.jpg)
Case Study 1
![Page 9: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/9.jpg)
Case Study 2:
Single Use Formulation and Filling for a Multi-Product Fill Finish Facility
![Page 10: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/10.jpg)
Case Study 2:
Single Use Formulation and Filling for a Multi-Product Fill Finish Facility
The Challenge
• Multiple Product Formats
• Cross Contamination
• Turnaround Time
• Future Products
The Solution
• Formulation using Single Use or SS Vessels. Multiple vessels/bags per product.
• Single use final filtration
• Peristaltic filling pumps with single use surge bag
• Dedicated Filling Needles
![Page 11: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/11.jpg)
Case Study 2:
Single Use Formulation and Filling for a Multi-Product Fill Finish Facility
Pro’s
• Flexible
• Short Turnaround
• Minimise risk of cross contamination
Con’s
• Infrastructure included for future SS System – Cost and real estate
![Page 12: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/12.jpg)
Case Study 3:
Single Use Formulation and Filling for an Existing Multi-product Fill Finish Facility
![Page 13: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/13.jpg)
Case Study 3:
Single Use Formulation and Filling for an Existing Multi-Product Fill Finish Facility
The Challenge
• Existing Facility
• Multiple Products Formats
• Cross Contamination
• Re-engineering of Existing Formulation and Filling
The Solution
• Single use: The right answer for future products
• Not advised to change existing product format designs
![Page 14: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/14.jpg)
Case Study 4:
Accelerating a Project Schedule
![Page 15: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/15.jpg)
Case Study 4:
Accelerating a Project Schedule
The Challenge
• New Bioreactor Installed
• WFI Distribution System Upgrade Qualification Complete 6 months later
• Bioreactor sitting Unused
The Solution
• Bagged WFI for Cleaning
• Sanitary Diaphragm Pump for Transfer
![Page 16: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/16.jpg)
Case Study 4:
Accelerating a Project Schedule
Pro’s
• Extra Batches produced
• Risk Mitigation
Con’s
• More Man-hours Spent
![Page 17: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/17.jpg)
How to Process Single Use Assemblies
![Page 18: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/18.jpg)
How to Process Single Use Assemblies
• Ready to Use
• In-House Processing
![Page 19: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/19.jpg)
Facility Considerations
![Page 20: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/20.jpg)
Facility Considerations – Processing Method
• LAF Booth – In-House
• Autoclave Capacity – In-House
• Warehouse Capacity – All
• Waste Treatment – All
• Waste Disposal and Transport – All
![Page 21: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/21.jpg)
Facility Considerations – Cleaning
• No CIP Skids/Not in initial scope
• No COP/SOP Stations/Not in initial scope
• Typically Parts Washer required, but less bespoke racks required
![Page 22: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/22.jpg)
Facility Considerations – Sterilisation
• Autoclave Capacity
• VHP Not Acceptable
• Transport of Sterile Components
![Page 23: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/23.jpg)
Facility Considerations – Filling
• Pump Technology
• Surge Container
• Transfer into Isolator/RABS
![Page 24: Single Use Systems for Aseptic Fill Finish - Facility ... Use... · Single Use Formulation and Filling for a Multi-Product Fill Finish ... Cost and real estate. ... • No COP/SOP](https://reader031.vdocument.in/reader031/viewer/2022021901/5b8654347f8b9a2e3a8ca784/html5/thumbnails/24.jpg)
Conclusion
Any Questions?
Thanks for Listening!
Hugh Hodkinson
Better
engineered
solutions