CPC 推出全新 MicroCNX 连接器，首次用于小批量生物制药加工
发布时间：2021 年 9 月 1 日

小管径焊接的唯一替代方案

丹尼森市，伊利诺伊州， 2021年9月1日/新华美通/ - CPC（冷产品公司）的一部分，多佛（纽约证券交易所代码：DOV）和广泛的单次使用的连接器制造商，今天宣布推出一个新的超- 紧凑型无菌连接器为生物制药制造商提供了一种急需的替代管焊接的小体积封闭无菌工艺。MicroCNX 系列连接器是业界首款无菌连接器，旨在提供一种简单、高效的方法来连接小型组件中的管道。

“MicroCNX 连接器是一系列生物加工、细胞治疗和基因治疗工作流程的关键选择，” CPC 生物制药业务高级产品经理Troy Ostreng说。“到目前为止，繁琐的管道焊接一直是对非常小口径的管道进行无菌封闭连接的 一方法。MicroCNX 连接器代表了该行业的一项巨大创新。”

MicroCNX 连接器专为涉及广泛使用的 1/16" (1.6mm)、3/32" (2.4mm) 和 1/8" (3.2mm) 管的小体积过程而设计。这些包括采样、种子序列扩展和早期涉及摇瓶和摇床的细胞培养过程。

“MicroCNX 系列旨在帮助制造商提高效率并减少创建封闭系统的时间和总成本，从而提供可靠、可重复的结果，”Ostreng 说。

测试表明，使用新连接器进行无菌连接的速度比使用管焊机的操作员快四倍。1意思是，在创建一个焊缝所需的时间内，多可以完成四个 MicroCNX 连接。将这些数字在一年中相乘，运营效率就很明显了。

使用 MicroCNX 连接器的简单三步过程需要少的培训。用户只需“捏-按-拉”：1）捏可取下保护盖；2) 将连接器的两半卡在一起；并且，3) 拉出保护膜，以便开始流动。相比之下，管焊接涉及十几个或更多步骤，操作员面临的挑战包括将管焊机操纵到位、处理设备维护以及需要精确的技术来创建成功的焊接。使用 MicroCNX 解决方案，不存在因焊接设备停机而导致焊接错误、焊机故障或生产延迟的风险。

使用无菌连接器无需购买、校准、验证和维护每台成本超过15,000 美元的管焊机。制造商通常需要多名焊工，这会占用洁净室的宝贵空间。

“验证新空间既昂贵又耗时，”Ostreng 指出。“MicroCNX 连接器可以帮助生物制药、细胞和基因治疗制造商充分利用他们现有的洁净室空间。”

为了确保流路畅通，管子焊接需要操作员在被焊缝卷曲后手动恢复管子的形状。相比之下，MicroCNX 连接器有助于为每个连接提供一致的流动路径。由于 MicroCNX 连接器可以集成到预制的管道组件中，操作员知道在哪里进行连接——他们无需猜测，这支持当前的良好制造规范 (cGMP)。新连接器的尺寸、重量和几何形状也非常符合用于细胞扩展等过程的紧凑型自动化设备的趋势。

有关 MicroCNX 系列连接器以及管焊接和无菌连接器比较的更多信息，请访问http://www.garye.cn/MicroCNX_Connectors.htm

档案资料。

关于 CPC：

CPC（Colder Products Company）是一次性连接技术的全球领导者，为生物制药制造提供各种连接器。创新、灵活的设计可轻松组合多个组件和系统，包括工艺容器、管道歧管、传输线、生物反应器和其他生物工艺设备。坚固的一次性连接器可保持介质的无菌性和完整性，同时提高产量、缩短上市时间并降低成本。该公司著名的 AseptiQuik 连接器即使在非无菌环境中也能提供快速简便的无菌连接。在cpcworldwide.com/bio 上了解有关我们整个产品组合的更多信息。与 Dover Corporation 旗下的运营公司 CPC 充满信心地联系。

关于 Dover：

Dover 是一家多元化的全球制造商和解决方案提供商，年收入约为70 亿美元。我们通过五个运营部门提供创新设备和组件、消耗品、售后零件、软件和数字解决方案以及支持服务：工程产品、加油解决方案、成像和识别、泵和过程解决方案以及制冷和食品设备。Dover 将全球规模与运营敏捷性相结合，引领我们服务的市场。我们拥有 24,000 多名员工的团队以拥有超过 65 年的创业方法而获得认可，采用主人翁心态，与客户合作重新定义可能。总部位于伊利诺伊州唐纳斯格罗夫，多佛在纽约证券交易所的交易名称为“DOV”。

CPC Launches New MicroCNX Connectors, a First for Small-Volume Biopharma Processing
Published: Sep 01, 2021

Only alternative to tube welding at small tubing sizes

DOWNERS GROVE, Ill., Sept. 1, 2021 /PRNewswire/ – CPC (Colder Products Company), part of Dover (NYSE: DOV) and maker of a broad range of single-use connectors, today announced the launch of a new ultra-compact sterile connector providing biopharmaceutical manufacturers a much-needed alternative to tube welding for their small-volume closed aseptic processes. MicroCNX Series Connectors are the industry's first aseptic connectors designed to provide a simple, efficient method of connecting tubing in small-format assemblies.

"MicroCNX connectors are a critically important option for a range of bioprocessing, cell therapy and gene therapy workflows," said Troy Ostreng, Senior Product Manager for CPC's biopharmaceutical business. "Until now, cumbersome tube welding has been the only way to make sterile closed connections of very small-bore tubing. The MicroCNX connector represents a huge innovation for the industry."

MicroCNX connectors are designed specifically for small-volume processes involving widely used 1/16" (1.6mm), 3/32" (2.4mm) and 1/8" (3.2mm) tubing. These include sampling, seed train expansion and early cell culture processes involving shaker flasks and rocker tables.

"The MicroCNX series was designed to help manufacturers improve efficiencies and reduce time and total cost in creating closed systems that deliver reliable, reproducible results," said Ostreng.

Testing indicates that making a sterile connection with the new connector is up to four times faster than an operator using a tube welder.1 Meaning, in the time required to create one weld, up to four MicroCNX connections could be completed. Multiply those numbers over the course of a year, and the operational efficiencies are clear.

The easy, three-step process for using MicroCNX connectors requires minimal training. Users simply "Pinch-Click-Pull": 1) pinch to remove the protective cover; 2) click together the connector halves; and, 3) pull out the protective membranes so flow can start. In comparison, tube welding involves a dozen or more steps, with operator challenges including maneuvering the tube welder into position, dealing with equipment maintenance, and requiring precise technique to create a successful weld. With MicroCNX solutions, there is no risk of faulty welds, welder breakdowns, or production delays due to weld equipment downtime.

Use of aseptic connectors eliminates the need to purchase, calibrate, validate and maintain tube welders that can cost more than $15,000 each. Manufacturers often need multiple welders, which take up valuable space in a cleanroom.

"It's expensive and time-consuming to validate new space," Ostreng noted. "MicroCNX connectors can help biopharmaceutical and cell and gene therapy manufacturers make the most of their existing cleanroom space."

In order to ensure a clear flow path, tube welding requires operators to manually restore the tubing's shape after being crimped by a weld. In contrast, MicroCNX connectors help deliver a consistent flow path with every connection. Because MicroCNX connectors can be incorporated into pre-made tubing assemblies, operators know where to make connections—there's no guesswork on their part, which supports current good manufacturing practices (cGMP). The size, weight and geometry of the new connector also fit well with the trend toward compact automated equipment for use in processes like cell expansion.

For more information about MicroCNX Series Connectors and how tube welding and aseptic connectors compare, visit endoftheweld.com.

1. Data on file.

About CPC:
CPC (Colder Products Company) is a global leader in single-use connection technology, offering a wide variety of connectors for biopharmaceutical manufacturing. Innovative, flexible designs easily combine multiple components and systems including process containers, tubing manifolds, transfer lines, bioreactors and other bioprocess equipment. Robust single-use connectors maintain media sterility and integrity while improving production yields, decreasing time to market and reducing costs. The company's well-known AseptiQuik connectors provide quick and easy sterile connections even in non-sterile environments. Learn more about our entire portfolio at cpcworldwide.com/bio. Connect with confidence with CPC, an operating company within Dover Corporation.

About Dover:
Dover is a diversified global manufacturer and solutions provider with annual revenue of approximately $7 billion. We deliver innovative equipment and components, consumable supplies, aftermarket parts, software and digital solutions, and support services through five operating segments: Engineered Products, Fueling Solutions, Imaging & Identification, Pumps & Process Solutions and Refrigeration & Food Equipment. Dover combines global scale with operational agility to lead the markets we serve. Recognized for our entrepreneurial approach for over 65 years, our team of over 24,000 employees takes an ownership mindset, collaborating with customers to redefine what's possible. Headquartered in Downers Grove, Illinois, Dover trades on the New York Stock Exchange under "DOV."

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