[Symposium Held] New Standards for Aseptic Manufacturing Following the Revision of Annex 1
We will introduce the points that pharmaceutical companies consider and the latest solutions. / A symposium will be held in October, and applications are currently being accepted!
The revised version of EU GMP Annex 1, which came into effect on August 25, 2023, has significantly expanded the documentation, particularly strengthening the sections related to barrier technology. The prevention of product contamination in aseptic manufacturing processes has become increasingly emphasized, and the introduction of isolators and RABS is recommended to minimize contamination risks from operators. This revision impacts pharmaceutical companies worldwide, making the formulation of contamination control strategies (CCS) essential for maintaining sterility. One of our solutions that meets these stringent aseptic requirements is the glove-less isolator integrated aseptic filling system "Versynta microBatch." It is a small-batch production unit designed for highly active formulations, utilizing robotic technology to eliminate manual intervention by operators. At the symposium in October, we will provide detailed explanations of the new standards for aseptic manufacturing following the Annex 1 revision and key points for pharmaceutical companies to consider, as well as introduce our latest solutions. [Overview] - October 7, 2024 (Monday): Tokyo - October 10, 2024 (Thursday): Osaka If you wish to participate, please refer to the related links below.
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basic information
You can download the Versynta microBatch flyer in accordance with Annex 1.
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Company information
Our company was established in 1982 as the Japanese base of Syntegon, one of the world's leading packaging machine manufacturers, and celebrated its 40th anniversary in 2022. For the pharmaceutical industry, we offer Japan's only integrated line, capable of providing everything from the filling of injectable drugs to appearance inspection. For oral dosage forms, we have a range of high-class granulation and capsule filling machines with proven performance worldwide. Additionally, we provide various packaging materials tailored to meet our customers' diverse needs. For the food industry, we offer confectionery manufacturing and packaging machines that can flexibly accommodate a wide variety of products, as well as food and beverage packaging machines such as aseptic filling and degassing systems. From development and design to manufacturing, validation, and after-sales service, we propose and provide reliable technology to meet customer needs.