4. Innovative Alternative
Closed
Sterile Drug System Multi-Chamber
Product Drug Cartridge
Sterile
Powder
Transfer
4
5. Presentation Overview
Closed System Sterile Powder Transfer
Purpose:
•Maintain a high level of sterility assurance while
moving drug product and materials through different
room classifications into the filling environment.
•Eliminate the need for repeated sanitization /
sterilization treatments.
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6. Presentation Overview
Key Objectives:
•To define the requirements and risks involved in
transferring drug product (powder) to the filling line
•To describe the sterilization steps for the powder
transfer components
•To describe how alpha / beta and aseptic
connections can be employed for a powder transfer
system
•To demonstrate how sterility assurance is
maintained throughout the process of transferring
sterile powder to the filling line
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7. Presentation Overview
Take Home Benefits:
•Introduction to closed system powder transfer
•Practical knowledge of rapid transfer port (alpha /
beta) connections
•Use of established GMP methods in a novel manner
•Introduction to use of these concepts for transfer of
other materials (stoppers, aluminium caps) to the
filling line
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8. Closed System
Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Automated Rapid Transfer Port
Isolator Filling Line
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9. Closed System
Sterile Powder Transfer
Transfer Chute
Within
Grade A Flexible Bellow Connection
Powder Distribution
Filling System
Multi-Chamber Drug Cartridge
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10. Quality By Design
Material of Construction:
•All product contact surfaces 316L stainless steel
•Electropolished
•Surface roughness Ra < 0.5µm (20 µinches)
•Steam sterilizable components
•Vapor Phase Hydrogen Peroxide compatible
materials
•Flexible materials silicone
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12. Closed System
Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Automated Rapid Transfer Port
Isolator Filling Line
12
13. Powder Sifter / Transfer Vessel
Existing equipment New equipment
13
14. Sifter / Transfer Vessel
Sifter:
•Raw material filtered to sifter
under positive pressure, Grade
A environment Transfer Vessel:
•Connected to transfer vessel •Sterilizable (steam-in-place
with sterile flex boot and autoclave)
•Nitrogen pressurized to
protect contents
•Variable sizes (10 – 300 liter
volumes)
•Compatible with lift system
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15. Vessel Features
Butterfly valve for
powder dosing from sifter Filter connection for
pressurization
Beta port for RTP Butterfly valve for Pressure gauge
connection powder dosing to isolator
15
19. Closed System
Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Automated Rapid Transfer Port
Isolator Filling Line
19
20. Lifting Device
• Automated lift system
• Programmable paths for
vessel docking
• Ergonomic
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26. Closed System
Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Automated Rapid Transfer Port
Isolator Filling Line
26
27. Rapid Transfer Port
• Alpha door
mounted in isolator
wall
• Beta cap mounted
on vessel
• False beta cap
installed during
isolator VPHP
• Non-sterile
surfaces mate and
door opens
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34. Closed System
Sterile Powder Transfer
Transfer Chute
Within
Grade A Flexible Bellow Connection
Powder Distribution
Filling System
Multi-Chamber Drug Cartridge
34
35. Transfer Chute
Preparation/protection of sterile product contact
surfaces:
•Sterilize chute inside autoclave bag with end caps
installed
•Unwrap and install chute assembly on support arm
prior to isolator VPHP decontamination
•Aseptically remove end caps using isolator glove ports
after isolator decontamination
•Powder discharge angle optimized at 50 degrees
•Tested to confirm no bridging during powder flow
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38. Flexible Bellow
Preparation/protection of sterile product contact
surfaces:
•Autoclave bellow inside sterilizable stainless steel
container
•Place container in isolator and seal prior to isolator
VPHP decontamination cycle
•Aseptically remove and install bellow using isolator
glove ports after isolator decontamination
•Bellow maintains contained system, while allowing for
powder bunker movement
38
44. Closed System
Sterile Powder Transfer
Transfer Chute
Within
Grade A Flexible Bellow Connection
Powder Distribution
Filling System
Multi-Chamber Drug Cartridge
44
50. Other Applications
This concept is effective for processing and transfer
of other materials (stoppers, aluminium caps) to the
filling line
Plungers and Disk Seals Tip Caps Serum and Lyo Stoppers
Needle Shields Aluminum Seals
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52. Component Processor
Purpose:
•Washing, siliconization,
sterilization, drying and cooling of
pharmaceutical closures.
•Contained system from component
loading until use at the filling line.
•Maintain a high level of sterility
assurance materials through
different room classifications into
the filling environment.
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53. Presentation Conclusion
Take Home Benefits:
•Introduction to closed system powder transfer
•Practical knowledge of rapid transfer port (alpha /
beta) connections
•Use of established GMP methods in a novel manner
•Introduction to use of these concepts for transfer of
other materials (stoppers, aluminium caps) to the
filling line
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55. Thank you for your attention!
Aaron Mertens
Atec Pharmatechnik
US Technical Support
Sörup, Germany
+1-440-530-0060
www.atecgroup.de
mertens@atecgroup.de
*These are not tools for the pharmaceutical industry and
should not be used in a clean room environment.
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