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Liquid Filling Line
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| Vial Filling Line |
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Vial Washer, Depyrogenation Tunnel, Filling/Stoppering machine, Freeze Dryer Loader/Unloader, Aluminum Over Capping machine, Rubber Stopper rinser, Handling systems, Formulation system, Isolators, and Final Packaging system. |
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Washer
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Depyrogenation Tunnel
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Filling Section
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Stoppering Section
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| Ampoule Filling Line |
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Ampoule Washer, Depyrogenation Tunnel, Filling/Sealing machine, Sealing Machine for Freeze Dried products, Formulation system, Isolators, and Final Packaging system. |
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Washer
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Depyrogenation Tunnel
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Filling Closing Machine
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| Syringe Filling Line |
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Syringe Washer, Siliconizing unit, Depyrogenation Tunnel, Filling machine, Sheath Stoppering machine, Vacuum Stoppering machine, Assembly Unit, Handling systems, Formulation system, Isolators, and Final Packaging system. |
| Low Speed combined Ampoule/Vial Filling Line |
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Ampoule/Vial Washer, Depyrogenation Tunnel, Filling/Sealing/Rubber Stoppering machine, Aluminum Over Capping machine, Tray loader, Formulation system, Isolators, and Final Packaging system. |
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Isolator
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Filling Section
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Aluminum Capping Section
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| PAsepT: Aseptic Filling System with PAT features |
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What is "PAsepT"?
"PAsepT" is a sterile drug manufacturing system developed by Shibuya based on the Process Analytical Technologies (PAT) initiative. PAT is a guide line for drug manufacturing introduced by the US Food and Drug Administration (FDA) as part of "A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance".
Key Features of the PAsepT system
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Robotic monitoring of the Filling Isolator Environment.
*Aseptic monitoring of the environment Air borne microbial count.
*Aseptic monitoring of the environment "Settle plate" microbial count.
*Aseptic monitoring of the rubber stopper bowl surface microbial count using a specially designed robot swab tool.
*Aseptic monitoring of the filling nozzle surface microbial count using a specially designed robot swab tool. |
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Direct real time monitoring of the depyrogenation temperature of the glass containers. |
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High accuracy filling with real time monitoring of the fill volume of every unit filled. |
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Real time monitoring of the Aluminum capping force for every unit capped. |
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In-house sterilizing and aseptic feeding of rubber stoppers without the need for any operator intervention. |
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Centralized control and monitoring of the CIP/SIP operations for the formulation through filling systems. |
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Dry heat sterilization of the depyrogenation tunnel cooling zone. |
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Conveyor-less direct handling of the containers using a neck handling system to minimize the disruption of the vertical unidirectional air flow in the Isolator. |
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Aseptic sampling of the product for sterility testing. |
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Automatic Environmental Monitoring Unit
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