Shibuya Corporation highlights its Vial Filling Systems, established aseptic solutions engineered to support reliable performance across multiple products and every stage of pharmaceutical vial preparation and filling.
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The system integrates washing, dry heat depyrogenation, filling, rubber stoppering, and aluminium cap sealing technologies into a cohesive, precision-controlled line. The isolators that provide the aseptic environment for this system are also designed in-house; the Vial Filling Systems operate in a Grade A/ISO 5 environment compliant with global regulatory standards. These isolator systems maintain stringent contamination control and the highest possible level of sterility assurance.
The Vial Filling Systems reflect Shibuya’s extensive experience in developing reliable high performance pharmaceutical manufacturing technologies. Each installation is designed and built around customer-specific throughput, formulation, and specific product filling requirements. Component washing machines, dry heat depyrogenation tunnels, and all other process critical equipment are also engineered and manufactured by Shibuya, ensuring that every stage of the process aligns seamlessly within the overall aseptic architecture.
At the start of the line, the ultrasonic washing machine delivers validated cleaning effectiveness including inverting the containers for efficient internal and external cleaning. Vials progress to the depyrogenation tunnel, where heated unidirectional HEPA filtered air performs validated depyrogenation under unidirectional airflow Grade A/ISO5 cleanroom conditions. Vials are cooled within a unidirectional air flow Grade A/ISO 5 cooling zone. In processes where containers are sterilised by vapour phase hydrogen peroxide, a high air change aeration system maintained at Grade A/ISO 5 particulate air quality ensures rapid removal of hydrogen peroxide vapour.
Filling and rubber stoppering operations utilise a double transfer rake design that maintains fast, yet stable vial handling coupled with reliable stopper placement to the depth required by the process. Multiple filling methods can be implemented, and an IPC automatic sampling unit supports routine in-process evaluation. The line concludes with Shibuya’s vial aluminium cap seaming system, engineered for consistent and secure seals that ensure container/closure integrity through transport to administration to the patient.
Because Shibuya designs and manufactures all major components, including isolators and RABS units, we can assure with complete confidence a perfectly integrated vial filling process and environment which provides the highest quality aseptic production, process efficiency, and long-term system reliability for a broad range of pharmaceutical applications.