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一次性组件

可随时发货的一次性组件助您满足紧张的日程

Mobius^® Essential组件是标准、现成、简单的生物工艺袋和管路组件。这类即拆即用的组件由我们成熟的 PureFlex™膜材制成，提供2D袋子(1–50 L)和3D袋子(100–200 L)两种型号，以及生物工艺管路组件。这类标准组件易于整合到您当前的工艺流程中，并可直接放大到 Mobius^® MyWay 定制组件（使用PureFlex™膜）。

免除设计和生产的前置时间
通过Mobius^® MyWay定制计划，可将1 L - 200 L规格轻松放大到高级组件

需要我们根据您的工艺需求来寻找合适的 Mobius^® Essential 基本组件吗？请填写一份简短表格，立即与我们的一次性产品专家联系。

索取更多信息

Mobius^® MyWay – 可满足您的供应需求的各种选择

Mobius^® MyWay是一个全面的三级计划，旨在促进一次性产品交货期与设计灵活性之间的平衡，同时增强供应安全性。Mobius^®MyWay 让您可以灵活地订购标准和可配置的“量身定制”的组件，同时还能在缩短交货期的情况下获得文档支持和可提取数据的益处。我们独特的方法减少了耗材管理负担和成本，提高了供应透明度，增进了安全性。

MOBIUS^® 库存

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MOBIUS^® 选择

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MOBIUS^® 选项

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即取即用的标准组件

根据订单利用预检合格组件库定制的组件

高灵活度定制解决方案

Mobius^®组件认证和放行测试

Mobius^® 组件可提供各种认证等级的产品。组件根据组件部件鉴定、生产中泄露测试水平以及组件生产后的批次测试等结果进行认证。认证水平是组件保质期和无菌声明的根据。

氦完整性生产放行测试实现增加的完整性保证

Mobius^® 一次性组件*也可用氦气密封完整性生产放行测试进行测试。.我们的氦气密封完整性测试 (HIT) 经验证可检测小至 2 µm 的缺陷，旨在测试整个一次性组件，包括管道和连接点。将 HIT 引入您的密封完整性保证策略可降低制造过程中泄漏或微生物侵入的风险。

* 用于氦气密封完整性测试的Mobius^®组件受设计空间规则的约束。详情见于氦气测试数据说明书。

认证等级	保质期	无菌性	USP <85>内毒素， USP <788> 不溶性颗粒物	泄露测试	USP <88>生物反应性体内 (Class VI), USP <661> 理化检测
金 + 氦气	2年	利用经验证25-40 kGy剂量进行后伽马辐照的灭菌	每批测试一个组件，后伽马辐照	100% 组件接受过氦气密封完整性测试	后伽马辐照
金	2 年	利用经验证25-40 kGy剂量进行后伽马辐照的灭菌	每批测试一个组件，后伽马辐照	100% 经过组件泄露测试	后伽玛辐照
银	2年	利用经验证25-40 kGy剂量进行后伽马辐照的灭菌	测试结果季度复核，后伽马辐照	过程中测试	后伽玛辐照
铜	无要求	进行25-40 kGy剂量的伽玛辐照	未测试	未测试	前伽玛辐照
基本物质	无要求	非无菌	未测试	过程中测试	前伽玛辐照

一次性膜技术

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多层包装材料的横切面，标明每层的组成和用途。

Ultimus^®膜特有编织尼龙的前沿设计。

Mobius® 反应袋组件附带PureFlex™和PureFlex™ Plus滤膜，可为您的一次性技术提供灵活性和稳定性。

Ultimus^® 膜通过独特的编织尼龙(woven nylon)构造实现优异的强韧度和耐久性，适合大容量工艺处理。液体接触层不含动物源成分，浸出物少，由于不含Irgafos^® 168试剂，有助于细胞健康生长。

我们的 PureFlex™滤膜可作为Mobius^® 一次性2D和3D反应袋的组件使用。PureFlex™和PureFlex™ Plus膜均由低可萃取率、化学耐受和零动物源性组分的单层流体接触膜组成，满足您在一次性使用生产全程所需的灵活性和稳定性。

想要了解Ultimus^®膜？请联系我们的技术专员。

联系我们的技术专员

Mobius^® 一次性组件由合规和控制智能平台Emprove^® 计划提供支持。

作为产品信息辅助，Emprove^®计划让您可以便捷获得Emprove^®档案中可靠的技术、监管和供应信息，支持持续的风险评估。高级资格认证档案基于您的一次性组件独有信息自定义。

生物工艺风险规避

我们拥有遍布全球的销售渠道开发专家和工程师网络，依托Millipore^® 验证服务，可在系统演示、设计和部署、大规模过程模拟、可行性研究以及验证研究和归档等方面为您提供支持。

相关资源

Application Note: Deviron^® Detergents for Viral Inactivation
Deviron^® C16 and Deviron^® 13-S9 Detergents for Solvent/Detergent Viral Inactivation of Plasma in Mobius^® Single-Use Containers
Brochure: Single-use Fluid Management
2D & 3D assemblies, filtration, storage, and transportation solutions
White Paper: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems
Single-use systems are increasingly popular in biomanufacturing. Their adoption offers numerous advantages for greater efficiency and productivity in applications such as final filtration, mixing and aseptic connections.
Technical Brief: Shipping Qualification of Mobius^® Large Liquid Transportation according to ISTA
Safe and efficient transportation of your large bulk liquid substances is critical. These liquids could include sterile water, buffers, media, intermediates, bulk drug substances and final drug products. Therefore, we completed an extensive ISTA shipping validation to provide the safest transportation for your critical bulk liquids.
White Paper: Single-Use Upstream Processing: Ultimus^® Film Delivers Comparable Cell Growth Performance To Glass
Single-use technologies are increasingly being incorporated into the biomanufacturing workflow to achieve greater efficiency and productivity, reduce capital investment in facilities and equipment, and minimize the risk of cross-contamination.
Infographic: Prevent Costly Bag Leaks in Single-Use Manufacturing
The Ultimus^® Film Difference Designed with a proprietary woven nylon structure, Ultimus^® film demonstrates superior strength and resilience to protect against leaks, abrasions, tears and material fatigue.
Technical Brief: Demonstrated Strength and Durability of Ultimus^® Film
Single-use technology is used for different operations throughout biomanufacturing including mixing, storage and transportation.
Spec Sheet: PureFlex™ Single-Use Process Container Films
PureFlex™ film is used to construct our Mobius^® single-use assemblies and Novaseptum^® sampling bags. These single-use products are used in biopharmaceutical processes, improving efficiency and productivity while reducing the risk of contamination.
Spec Sheet: Ultimus^® Film
Ultimus^® film was designed to meet the needs of more challenging single-use applications such as large-volume liquid processing. Our Ultimus^® film technology provides enhanced bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon.
Data Sheet: Mobius^® 2D Freeze Assembly
Mobius^® 2D Freeze Assembly Data Sheet
Spec Sheet: Mobius^® Essential Assembly
Mobius^® Essential Assembly Spec Sheet

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相关网络研讨会

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EU GMP Annex 1 Draft - Closed System Design Consideration with Single Use Systems

网络研讨会：欧盟GMP附录1草案 - 一次性系统封闭系统设计注意事项

Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. During this webinar we will focus on points to consider assuring sterility and integrity of a single-use assembly, and how collaboration between supplier and end-user can support the overall contamination control strategy of final filtration and filling operation.

Webinar: Regulatory Considerations including Extractables & Leachables for Single-Use Manufacturing

网络研讨会：关于一次性生产中可萃取物和溶出物等的监管考虑因素

A successful adoption of single use technology in a Biopharmaceutical process largely relies on the confidence in selection of such materials. Understanding the regulatory and industry expectations are important to streamline the implementation and approval process.

Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and Tomorrow

网络研讨会：即将实行的USP 665—— 一次性系统表征水平的今天和明天

Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.

Webinar: Process Equipment Characterization – How Standardized Extractables Data Support E&L Risk Assessment

网络研讨会：工艺设备表征 – 如何利用标准化可萃取物数据支持E&L风险评估

This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.

Challenges using Multiple Single-use Systems: Functionality versus Extractables and Leachables

网络研讨会：同时使用多个一次性系统的难题：功能性与可萃取物和溶出物的对比

A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.

Webinar: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems

网络研讨会：BPOG可萃取物数据在促进一次性系统有效利用中的作用

The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.

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