Flexible Aseptic Manufacturing
-
Upload
automated-systems-of-tacoma-ast -
Category
Documents
-
view
3.798 -
download
1
description
Transcript of Flexible Aseptic Manufacturing
![Page 1: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/1.jpg)
FLEXIBLE ASEPTIC MANUFACTURINGTRADITIONAL VS. FLEXIBLE ASEPTIC MANUFACTURING
Steve Walter, GMP Technology SpecialistCDI Life Sciences
Josh RussellPrincipal EngineerAST
![Page 2: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/2.jpg)
Objective / Agenda
Provide an overview and comparison between traditional and flexible aseptic manufacturing, the impact to facility, operations, and cost.
•Industry Trends & General Requirements•Traditional Aseptic Processing Overview•Flexible Aseptic Processing Overview•Comparison Between Tradition and Flexible Approaches•Operational Differences•Cost & Savings
![Page 3: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/3.jpg)
Trends & General Requirements
• Small scale, high value, patient focused
• Fast turnaround time and clinic responsiveness becoming more critical
• New products are highly potent at the filling stage
• Leaner, modular, simpler• Superior flexibility – multi-format,
multi-product, multiple dosing options
![Page 4: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/4.jpg)
CNC CNCCNC/Grade D Grade C
Traditional Aseptic Processing
Depyro
Wash FillComp Prep
Capping
Comp Prep
WashDepyr
o
Stopper
Comp Prep
De-Bag
Tub Decon
![Page 5: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/5.jpg)
Traditional Aseptic Processing
• Dedicated fill-finish capabilities for a specific container type or “format”
• Adding additional container filling capabilities is a significant investment in facilities, time and equipment
• Processing challenges include glass on glass contact, machine jams, broken containers, etc.
• Very efficient for high volume dedicated products where flexibility is not necessary
![Page 6: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/6.jpg)
Flexible Aseptic Processing
• Integrates best in industry technologies
• Simplifies the manufacturing process
• Ability to fill multiple container formats & sizes
• Common facility with reduced floor space and utilities
• Increased asset utilization
Flexibility is the antidote to uncertainty
![Page 7: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/7.jpg)
Enabling Technologies
• Ready-To-Fill Containers• Vials, Syringes, Cartridges
and Infusion Bags• WFI Washed, <1
EU/Container, EtO Sterilized• Cartridges have line seal &
crimp cap placed, and oriented like a pre-filled syringe
• No glass on glass contact
• Ready-To-Use Components
![Page 8: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/8.jpg)
Enabling Technologies• Single-Use Product Pathway
• Peristaltic & time-pressure• Minimal product holdup• Containment of potent compounds
![Page 9: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/9.jpg)
Enabling Technologies• Isolator Barrier
Technology + Robotics• Provides full separation
between the operator and the process
• Compatible with VHP bio-decontamination
• Recipe driven operation• Maximum flexibility and
functionality• Negligible particle
generation
“Automation of other process steps, including the use of technologies such as robotics, can further reduce risk to the product.” Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (Pg.10)
![Page 10: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/10.jpg)
Flexible Aseptic Processing
CNCGrade D or C
• Consolidated manufacturing process that allows multiple container formats to be filled and finished on a single system.
• Interchangeable robot tooling specific to container
Capping
RapidDecon
Chamber
Comp Prep
![Page 11: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/11.jpg)
Physical Attributes
Hard walls, interlocked doors, glove ports, transfer ports
Stainless walls, sealed unit, glove ports, transfer ports, bio-decon system
Stainless walls, sealed unit, minimal glove ports, transfer ports, bio-decon system
Room Classification ISO 7 Min ISO 8 ISO 8
Air HandlingRoom HVAC or Separate AHU
Separate AHU & HVAC, Leak Tight, Outside Venting
Separate AHU & HVAC or Integrated , Leak Tight, Outside Venting
Bio-Decon Manual, Glove Autoclaving Automatic
Automatic, Shorter Duration depending on components
Environmental Monitoring Portable or Built-In Built-In Built-In / Automated
GowningClass 5 or 7 Gowns, Glove Port Usage
Class 8 Gowns, Glove Port Usage Class 8 Gowns
Glove Testing Visual, Automatic Visual, Automatic If Required
ASEPTIC PROCESSING COMPARISON
Criteria RABS Isolator Robotic Isolator
Comparison
![Page 12: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/12.jpg)
Material TransferMousehole, Load Lock, RTPs, DRAWERS
Mousehole, RTP, Transfer Isolator
RTP, Transfer Isolator, Staging Isolator
Emphasis of Training SOPs
Gowning, Aseptic Technique, Barrier Cleaning, Transfer Methods, Glove Inspection & Testing
Barrier Control System, Transfer Methods, Glove Inspection & Testing, Bio-Decontamination
Barrier Control System, Transfer Methods, Bio-Decontamination
Capacity All Speeds All SpeedsLimited / # Of Modules or filling heads
Floor Space
Minimized: Minimal gowning functions, Component Prep Varies
Minimized: Gowning functions, Minimal Component Prep, Support equipment: A/C, Depyro and Wash not required
Access for Change Over Gowned with open doors
Easy with Open Doors / Manual
Minimal: Automatic -Machine settings are stored as recipe. Some pieces of tooling
Operating Costs High Medium Low
Validation Complexity Moderate - Risk with Airflows
Medium - Utilizing FAT/SAT results
Low - Repeatability of Robots and no interventions
ASEPTIC PROCESSING COMPARISONCriteria RABS Isolator Robotic Isolator
Comparison
![Page 13: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/13.jpg)
Criteria Isolator Flexible
Glove Testing Visual / Automatic (Qty)
Visual / Automatic – (Qty - Minimal)
Training / SOPs Aseptic Technique / Transfer
Limited Operator interface during set up
Component Prep Varies No Wash / Depyro
Change Over Operator Set Up Programmed with integrated tooling
Utilization Depends on Set Up, Change Out and
Reduced process steps – Increased Up Time
Product Path Cleaning / Steam In Place
Single Use Assembly
Operational Differences
![Page 14: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/14.jpg)
Criteria Isolator Flexible
Receipt of Materials
Packed Glass Tub / Tray RTU
Component Prep Unwrap / Wash Unwrap / Stage
Waste Packaging Discarded
Trays / Tubs utilized through capping
Sterilization / Decontamination Time
Low Driven lower with smaller environment and isolated decontamination
Operators Required for setup, changeover
Automated – setup, changeover
Operational Differences
![Page 15: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/15.jpg)
* Component prep area is included in the overall area of vial filling & capping.
Area Isolator (SF/SM) Flexible (SF/SM)
Vial Filling & Capping 2100 / 195 900 / 84
Gowning 120 / 11 120 / 11
Degowning 80 / 8 80 / 8
Material Air Lock (MAL)
100 / 9 100 / 9
Comp Prep / Material Staging
Note * 300 / 28
Total Area 2400 / 223 1500 / 140
35 – 40% Decrease in required functional areas
Impact to Layout
![Page 16: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/16.jpg)
Space /Area Gr $/SF (US / €)
Isolator (SF/SM)
$ Isolator(US / €)
Flexible (SF/SM)
$ Flex(US / €)
Vial Filling & Capping
C 425 / 316
2100 / 195
892,500 / 663,840
900 / 84 405,000 / 301,240
Gowning C 425 / 316
120 / 11 54,000 / 40,165
120 / 11 54,000 / 40,165
Degowning C 425 / 316
80 / 8 36,000 / 26,775
80 / 8 36,000 / 26,775
MAL C 425 / 316
100 / 9 45,000 / 33,475
100 / 9 45,000 / 33,475
Comp Prep / Matl Staging
D 300 / 223
Note * 0 300 / 28 90,000 / 66,942
Totals 2400 / 223
1,027,500 / 764,254
1,500 / 140
630,000 / 468,594
Cost Impact - Facility
* Component prep area is included in the overall area of vial filling & capping.
![Page 17: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/17.jpg)
Flexible, Multi-Format Facility
![Page 18: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/18.jpg)
Flexible, Multi-Format Facility
Fill Suite Size:3600 SF / 335 SM
![Page 19: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/19.jpg)
Size, Cost & Equipment
• Facility Size• Reduce operating areas by 30-40%
• Facility Cost• Reduced engineering / design & construction costs• Reduced construction / constructability challenges• Reduced capital equipment investment
• Equipment Operations• Eliminate washing and depryogenation operations from the
manufacturing site• Increase equipment utilization• Single fill line has the ability to process multiple container
formats• Eliminates some of the most common routine interventions
![Page 20: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/20.jpg)
Conclusions
• Flexible aseptic processing simplifies the traditional aseptic manufacturing process
• Flexible aseptic processing leverages the strengths of best in industry technologies to:• Focus on core aseptic manufacturing processes• Provide an adaptable platform capable of multi-
container format filling• Minimize routine operator interventions• Reduce facility size, utilities, cost, and validation • Increase operational efficiency
![Page 21: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/21.jpg)
Acknowledgements:
Andrew Scherer, President, SmartFit Modular
George Wiker, Principal, SmartFit Modular
Chris Tyree, Ompi North America
![Page 22: Flexible Aseptic Manufacturing](https://reader033.fdocuments.in/reader033/viewer/2022061214/547d4cc4b4af9f9b158b5424/html5/thumbnails/22.jpg)
Thank You!
Joshua Russell, Principle Engineer – Life SciencesAutomated Systems of Tacoma (AST)4110 South Washington St. Tacoma, WA 98409(253) [email protected]
Steven Walter, GMP Technology SpecialistCDI Life Sciences1801 Market Street, Ste. 1300, Philadelphia, PA 19103(215) [email protected]