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首頁產品製藥與生物製藥製造流體管理一次性組件

一次性組件

即用型一次性組件助您滿足嚴苛時程要求

Mobius^® 基礎組件為標準化、現貨供應的簡易生物製程袋與管路組件。這些即插即用的組件採用我們久經考驗的PureFlex™薄膜製成，提供2D袋（1–50公升）、3D袋（100–200公升）以及生物製程管路組件。這些標準組件可輕鬆整合至現有製程，為您提供一條通往採用PureFlex™薄膜的Mobius^® MyWay組件的直線擴產路徑。

消除設計與製造的交貨期
1公升至200公升規格，可輕鬆升級至Mobius^® MyWay計畫下的高端組件

需要協助挑選符合製程需求的Mobius^® Essential組件？立即填寫簡短表單，與我們的單次使用專家聯繫。

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Mobius^® MyWay – 滿足您供應需求的多元選擇

Mobius^® MyWay 是一項全面的三層級計畫，旨在促進一次性產品交期與設計靈活性的平衡，同時提升供應保障。透過 Mobius^® MyWay，您既能靈活訂購標準化與可配置的「適用於特定用途」組件，又能以縮短的交期獲得文件支援與可提取數據的優勢。我們獨特的方案能減輕耗材管理負擔與成本、增強供應透明度，並提升保障性。

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莫比烏斯^® 股票

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莫比烏斯^®精選

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莫比烏斯^® 選擇

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現成標準組件

按訂單配置組件，採用預先合格組件庫

高度客製化解決方案

Mobius^® 組件認證與釋放測試

Mobius^® 組件提供多級認證等級。組件認證依據包含：組件內各元件的合格性、製造過程中實施的洩漏測試等級，以及製造後對整批組件進行的測試。認證等級亦影響該組件所標示的保存期限與無菌性聲明。

氦气完整性制造放行测试，提升完整性保障

Mobius^® 單次使用組件* 亦可進行氦氣完整性生產釋出測試。本氦氣完整性測試經驗證可偵測小至 2 微米的缺陷，並針對整組單次使用組件（含管路與連接點）進行檢測。將氦氣完整性測試納入完整性保障策略，可降低生產流程中發生洩漏或微生物侵入的風險。

* 適用於氦氣完整性測試的Mobius^®組件須遵循設計空間規範，詳情請參閱氦氣測試數據表。

認證等級	保存期限	無菌性	USP <85> 內毒素， USP <788> 亞可見顆粒物	洩漏测试	USP <88> 體內生物反應性（第六類）， USP <661> 物理化學測試
金箔 + 氦气	2年	採用驗證之25-40千戈瑞伽馬輻射滅菌	每批次测试1组装件，于伽马辐射后进行	100%組件氦氣完整性測試	伽馬輻射照射後
GOLD	2年	採用驗證之25-40千戈瑞伽瑪輻射劑量進行滅菌	每批次1組件經測試，並於伽馬輻射後實施	100% 組件洩漏测试	伽马辐射照射后
銀級	2年	採用驗證過的25-40千戈瑞伽瑪輻射劑量進行滅菌	每季審查結果，伽瑪輻射照射後	製程中測試	伽马辐射后
青銅級	無申訴	暴露於25-40千戈瑞之伽瑪輻射水平	未執行測試	未進行測試	預伽馬輻射照射
基本	無聲明	非无菌	未進行測試	製程中測試	γ射线照射前

一次性薄膜技術

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分層包裝材料的橫截面，附有標示各層組成與用途的標籤。

Ultimus^® 薄膜採用尖端設計，結合編織尼龍材質。

Mobius® 袋組件採用 PureFlex™ 與 PureFlex™ Plus 薄膜製成，具備靈活性與堅固性，可支援您的單次使用技術。

我們的Ultimus^®薄膜採用專利尼龍編織結構，專為大容量處理提供卓越的堅固性與耐用性。其流體接觸層不含動物來源成分，具有低可萃取特性，且因不含Irgafos^® 168，能支持健康的細胞生長。

PureFlex™ 薄膜用於製造 Mobius^® 單次使用 2D 與 3D 袋組件。PureFlex™ 與 PureFlex™ Plus 薄膜均採用單一流體接觸層，具備低可萃取特性、耐化學性材質及零動物來源成分，為您的單次使用製造流程提供所需的靈活性與堅固性。

對 Ultimus^® 薄膜有疑問？請聯繫我們的技術專家。

聯絡我們的技術專家

Mobius^® 單次使用組件由 Emprove^® 計畫提供支援——掌握合規與控制的智慧之道

作為產品組合的延伸，Emprove^®計劃透過Emprove^®檔案庫提供便捷途徑，讓您獲取可靠的技術、法規與供應資訊，持續支援風險評估流程。我們的進階認證檔案將針對您的單次使用組件，量身定制專屬技術資訊。

生物製程風險緩解

憑藉遍佈全球的銷售開發專家與工程師網絡，我們能為您提供系統演示、設計與實施、規模化製程模擬、可行性研究，以及驗證研究與文件編製等全方位支援，並由Millipore^®驗證服務提供技術背書。

相關資源

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
Application Note: Higher Volume Processing Using Natrix^® Q Device
This application note describes a series of tests to assess performance of a Mobius^® tubing assembly containing two Natrix^® Q Process 600 devices manifolded in parallel.
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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相關線上研討會

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線上研討會：歐盟GMP附件1草案——採用一次性系統的封閉系統設計考量

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.

網路研討會：一次性製造的法規考量，包含可萃取物與可浸出物

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.

線上研討會：即將實施的USP 665標準——當今與未來一次性系統的特性化程度

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.

網路研討會：製程設備特性化——標準化可萃取物數據如何支援設備與製程風險評估

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.

線上研討會：使用多種一次性系統的挑戰：功能性與可萃取物及可浸出物之權衡

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.

網路研討會：BPOG可萃取物數據在有效採用一次性系統中的角色

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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