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Ten23 health在瑞士维斯普举办了其最先进的VIVA2®无菌生产设施的盛大开业典礼

Ten23 health hosts Grand Opening of its State-of-the-Art VIVA2® Sterile Manufacturing Facility in Visp, Switzerland

PHARMA FOCUS ASIA 等信源发布 2024-09-24 17:20

可切换为仅中文


ten23 health®, a leading Swiss contract development and manufacturing organization (CDMO), yesterday proudly hosted the Grand Opening of its VIVA2® facility in Visp, Switzerland.The event marks a significant milestone in the company's growth, as the newly constructed VIVA2® facility is one of the most advanced and energy efficient of its kind.

瑞士领先的合同开发和制造组织(CDMO)ten23 health®昨日骄傲地在瑞士维斯普(Visp)举办了VIVA2®工厂的盛大开业典礼。此次活动标志着公司发展的一个重要里程碑,因为新建的VIVA2®设施是同类设施中最先进、最节能的设施之一。

It will provide significant capacity for commercial, as well as clinical fill/finish of vials, syringes and cartridges, in combination with dedicated Quality Control microbiology labs and related office space.The two additional sterile manufacturing lines include Line 2, a large-scale commercial and clinical filling line for ready-to-use (RTU) primary packaging for syringes, cartridges and vials; and Line 3, a clinical to commercial bulk vial filling facility, including two larger-scale freeze driers (lyophilizers).

它将与专门的质量控制微生物学实验室和相关办公空间相结合,为小瓶、注射器和药筒的商业和临床填充/完成提供巨大的容量。另外两条无菌生产线包括生产线2,这是一条用于注射器,药筒和小瓶的即用型(RTU)初级包装的大型商业和临床灌装线;和第3线,一个临床到商业的批量小瓶灌装设施,包括两个较大规模的冷冻干燥机(冻干机)。

The combined output is estimated to be 30 to 70 million units. ten23's Line 2 is an 8-headed filling machine and scale-up version of Line 1; both lines are based on Class C isolator technology and utilize filling with automated robots, and peristaltic and piston pumps. This enables optimal processing and controls, including 100% fill weight control, and ultra-high fill and stopper setting precision for syringes and cartridges.

综合产量估计为3000万至7000万台。ten23的2号线是一台8头灌装机,是1号线的放大版;这两条生产线均基于C类隔离器技术,并利用自动机器人、蠕动泵和活塞泵进行灌装。这可以实现最佳的处理和控制,包括100%填充重量控制,以及注射器和墨盒的超高填充和塞子设置精度。

The technology means that filling is effectively headspace-free, and container-to-container contact is avoided. ten23 can process glass or polymer containers and has experience of processing ultra-viscous formulations such as for subcutaneous or intravitreal use.In line with the company's commitment to sustainability and the environment, the pioneering building generates enough energy to continuously meet its own demands (and providing surplus energy to the grid), with a cutting-edge fac;ade comp.

该技术意味着灌装有效地避免了顶空,避免了容器与容器之间的接触。ten23可以处理玻璃或聚合物容器,并具有处理超粘性制剂(例如皮下或玻璃体内使用)的经验。根据公司对可持续发展和环境的承诺,这座开创性的建筑通过尖端的fac产生足够的能源来持续满足自己的需求(并为电网提供多余的能源);ade公司。