closed system powder transfer
DESCRIPTION
TRANSCRIPT
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Innovations in Closed System
Sterile Powder Transfer
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Problem
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Need a reliable and innovative solution to move material…
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Reliable solution but…
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Innovative Alternative
Sterile Drug Product
Multi-Chamber Drug Cartridge
Closed System Sterile
Powder Transfer
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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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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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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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Closed System Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Isolator Filling Line
Automated Rapid Transfer Port
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Closed System Sterile Powder Transfer
Transfer Chute
Flexible Bellow Connection
Powder Distribution
Filling System
Multi-Chamber Drug Cartridge
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Within Grade
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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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It Starts Here
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Closed System Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Isolator Filling Line
Automated Rapid Transfer Port
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Powder Sifter / Transfer Vessel
Existing equipment New equipment
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Sifter / Transfer Vessel
Transfer Vessel:•Sterilizable (steam-in-place and autoclave)•Nitrogen pressurized to protect contents•Variable sizes (10 – 300 liter volumes)•Compatible with lift system
Sifter:•Raw material filtered to sifter under positive pressure, Grade A environment•Connected to transfer vessel with sterile flex boot
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Vessel Features
Filter connection for pressurization
Butterfly valve for
powder dosing to isolator
Beta port for RTP connection
Pressure gauge
Butterfly valve for
powder dosing from sifter
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Powder Transfer: Sifter to Vessel
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Problem
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Reliable solution but…
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Closed System Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Isolator Filling Line
Automated Rapid Transfer Port
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Lifting Device
• Automated lift system• Programmable paths for
vessel docking• Ergonomic
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Vessel and Lifting Device
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Docked Vessel
• Alpha / beta connection• Automated rapid transfer
port (RTP)
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Vessel Docking to Isolator
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Problem
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Reliable solution but…
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Closed System Sterile Powder Transfer
Powder Sifter
Mobile Storage / Transfer Vessel
Docked Vessel
Isolator Filling Line
Automated Rapid Transfer Port
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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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Transfer Chute, Beta Port, Ring of Concern
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Transfer Chute, Beta Port, Ring of Concern
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Transfer Chute, Beta Port, Ring of Concern
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Automated Rapid Transfer Port
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Problem
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Reliable solution but…
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Closed System Sterile Powder Transfer
Transfer Chute
Flexible Bellow Connection
Powder Distribution
Filling System
Multi-Chamber Drug Cartridge
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Within Grade
A
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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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Isolator: Transfer Chute Insertion
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Isolator: Transfer Chute Insertion
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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
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Flexible Bellow Connection
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Flexible Bellow Connection
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Flexible Bellow Connection
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Powder Transfer: Vessel through Chute / Bellow
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Vessel Docking, RTP, Chute, Bunker
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Closed System Sterile Powder Transfer
Transfer Chute
Flexible Bellow Connection
Powder Distribution
Filling System
Multi-Chamber Drug Cartridge
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Within Grade
A
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Transfer Chute / Flexible Bellow / Powder Bunker
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Powder Bunker / Distribution System
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Transfer Chute / Flexible Bellow / Powder Bunker
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Distribution System
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Problem Solved
Closed System Sterile
Powder Transfer
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Other Applications
This concept is effective for processing and transfer of other materials (stoppers, aluminium caps) to the filling line
Plungers and Disk Seals
Aluminum SealsNeedle Shields
Serum and Lyo StoppersTip Caps
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Component Processing System
UnclassifedCleanroom D or C
Isolator
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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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Presentation Conclusion
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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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Acknowledgements
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Bausch and Ströbel
SKAN AG
Beckman Machine
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Thank you for your attention!
*These are not tools for the pharmaceutical industry and should not be used in a clean room environment.
Aaron MertensUS Technical Support
Atec PharmatechnikSörup, Germany
www.atecgroup.de
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