Maintaining the required purity, safety, and efficacy of medicines is critical in all aspects of pharmaceutical and biopharmaceutical manufacturing. Product quality assurance and control are essential to fulfilling manufacturing obligations, ensuring product safety, regulatory compliance, and maintaining patient trust.
It is particularly critical, given the routes of administration, that the microbiological safety is completely assured for all products labeled sterile. Understandably, the manufacture of sterile drugs using aseptic processing is considered the most risk intensive and therefore the most exacting manufacturing challenge in the healthcare product manufacturing industry. Shibuya Corporation recognizes this challenge, and we are proud to manufacture state-of-the-art, fully integrated vial filling systems designed and validated to assure contamination-free aseptic processing—from component washing and sterilization to filling, stoppering, and aluminum capping—thereby ensuring that patient safety and compliance are requirements are not only met but exceeded.
Shibuya Corporation has decades of experience providing the highest performance manufacturing equipment to sterile product medicines manufacturers worldwide. We are proud to be pioneers in advanced aseptic processing, using separative technologies with over three decades of experience supplying reliable, state-of-the-art advanced aseptic systems.
Shibuya provides end-to-end solutions that integrate every stage of each sterile product manufacturing system into a single validated platform. Because we design and manufacture every major sub-system in-house, including isolators, decontamination systems, washers, depyrogenation tunnels, filling machines, and product closure systems. Shibuya ensures consistent performance, regulatory compliance, operational Grade A/ISO 5 cleanroom conditions wherever required throughout the process.
Advanced Isolator Systems for Safety, Efficiency, Economic Benefit, and Ease of Implementation.
The entire purpose of advanced aseptic processing environments such as isolators is to ensure sterility. Isolators separate the human operator from the Grade A/ISO 5 aseptic critical zone, enabling the complete absence of human sourced contamination.
However, Shibuya’s attention to engineering detail ensures that our advanced isolator systems are optimized for smooth, reliable and efficient implementation, validation and manufacturing. Our goal is to make the implementation of advanced technology simple for the firms that purchase our systems and for their employees; thereby ensuring efficient manufacturing that yields the safest sterile products possible for our customer’s customers. We do that by ensuring ongoing regulatory compliance and an optimized customer experience.
Fully Integrated Solutions to Meet Our Customers’ Requirements
We understand that although many aseptically filled products require similar filling and component handling requirements, each client may have specific needs. We evaluate each customer’s chosen container/closure requirements to deliver a thoroughly tested system that maximizes efficiency, reduces contamination risk, and supports long-term reliability. Shibuya manufactures systems that are readily adaptable for a wide range of pharmaceutical products and we stand ready to support manufacturers whose product development requires the adaptation of existing Shibuya equipment to handle new products with differing container/closure systems. Our emphasis on modularity makes necessary capabilities updates easier to implement and validate while creating a simpler path to regulatory approval.
Shibuya’s fully integrated vial filling systems reflect the company’s commitment to innovation, quality, regulatory compliance and customer service throughout the product life cycle enabling pharmaceutical manufacturers to confidently achieve sterility assurance, operational efficiency, and consistent product reliability.
Learn more about Shibuya’s vial filling systems and explore fully integrated solutions for your aseptic production at www.shibuya.co.jp/en/pharmaceutical/pms07.html.