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首頁產品製藥與生物製藥流體管理一次性組件

一次性組件

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兩個穿著白色防護服、戴著手套和頭套的人站在不銹鋼推車旁，推車裡放著金黃色的大袋子。

單次使用型 Mobius® Essential 簡易生物製程袋和管道組件

Mobius^® 基本組件可輕鬆整合至您的工作流程中，提供 2D 和 3D 生物製程袋組件，尺寸範圍從 1 L - 200 L，以及三種生物製程管路設計。

Mobius<sup>®</sup> 3D 組件範例

Ultimus^® 薄膜現在可用於 Mobius^® 3D 組件。

我們的 Ultimus® 薄膜技術透過編織尼龍強化的新型強度層，提供更強的生物製程袋強度、更佳的耐用性和防漏性。

我們的 Ultimus^® 薄膜專為滿足更具挑戰性的一次性使用應用 (例如大容量液體處理) 而設計。

Mobius^® 2D 和 3D 袋組件

我們的 Mobius^® 2D 和 3D 組件提供高效且可擴充的生物製程液體管理解決方案，從培養基和緩衝液製備到最終灌裝應用。我們提供各種不同認證等級的標準與客製化解決方案，讓您的一次性使用技術更具彈性、流動性和支援性。

Mobius^® 2D Freeze Assemblies for frozen Liquid Transportation and Storage are made with our PureFlex™ film and Helium integrity tested to assure integrity at temperature down to -80 °C.
Mobius^®標準 2D 裝配，經過消毒，可在廣泛的應用中使用。
Mobius^®標準 3D 桶組，採用 Pureflex™ 薄膜，經消毒後即可用於流體儲存或處理應用。
Mobius^®標準 3D Bin Assemblies 採用 Ultimus^® 薄膜或 Pureflex™ flms 製成，採用我們的 EZ Fold 技術，設計方便運輸和儲存。

部分概述

Mobius^® 必備組件
Mobius^® MyWay - 滿足您供應需求的選項
Mobius^®組裝認證&釋放測試
Mobius^{® Single-use Assemblies & the Emprove^® Program}
生物製程風險減緩

選購產品

Mobius® 二維凍結組件 Mobius® 標準 2D 組件 Mobius® 標準 3D 鼓組件 Mobius® 標準 3D 倉庫組件

即時出貨的單次使用組件有助於滿足您極具挑戰性的時間要求

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Mobius^® Essential Assemblies 是標準、現成、簡單的生物製程袋和管道組件。這些隨插即用的組件由我們經過驗證的 PureFlex™ 薄膜製成，有 2D 袋 (1-50 L)、3D 袋 (100-200 L) 以及生物製程管路組件可供選擇。這些標準組件可輕鬆整合至您目前的製程，讓您可以直接擴充至使用 PureFlex™ 薄膜的 Mobius^® MyWay 組件。

縮短設計和製造前置時間
1 L - 200 L 尺寸，可輕鬆擴充至 Mobius® MyWay 的優質組裝。sup>®MyWay計畫，可輕鬆升級為優質組件

需要協助找到適合您加工需求的Mobius^®基本組件嗎？請填寫簡短的表格，立即與我們的單次使用專家聯繫。

索取更多資訊

Mobius^® MyWay - 滿足您供應需求的選項

Mobius^® MyWay 是一項全面的三層計劃，旨在促進單次使用前置時間與設計靈活性之間的平衡，同時增強供貨安全性。Mobius^®MyWay可讓您彈性訂購標準與可配置的「適合用途」組件，同時仍能在縮短的交貨期內獲得文件支援與可擷取資料的好處。我們獨特的方法可降低耗材管理的負擔和成本，提高供應透明度，並改善安全性。

MOBIUS^® STOCK

Icon with a turquoise hexagonal chain design inside a shield-like shape.

MOBIUS^® SELECT

Icon featuring interconnected geometric shapes including hexagons and triangles within a shield-like shape

MOBIUS^® 選擇

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現成的標準組件

使用預先驗證的元件庫，按序配置組件

高度客製化的解決方案

Mobius^®組件認證&釋放測試

Mobius^® 組件有多種認證等級。組件的認證是基於組件中元件的合格性、製造過程中執行的洩漏測試等級，以及製造後對組件批次執行的測試。

氦氣完整性製造釋放測試以提高完整性保證

Mobius^®一次性使用組件*也可以使用氦氣完整性製造釋放測試進行測試。我們的氦氣完整性測試已通過驗證，可檢測出小至 2 µm 的缺陷，其設計目的是測試整個一次性使用組件，包括管路和連接點。將氦氣完整性測試納入您的完整性保證策略，可降低製程中的洩漏或微生物入侵風險。

* 氦氣完整性測試的Mobius^®組件需符合設計空間規則。詳情請參閱氦測試資料表.

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單次使用薄膜技術

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分層包裝材料的橫截面，標籤顯示每層的組成和用途。

Ultimus^® 薄膜採用編織尼龍的尖端設計。

Mobius® 袋組件採用 PureFlex™ 和 PureFlex™ Plus 薄膜製成，具有彈性和堅固性，可支援您的一次性使用技術。

我們的Ultimus^®薄膜是透過專利的尼龍編織結構設計，在大容量製程中具有優異的堅固性和耐用性。流體接觸層不含動物來源，可萃取性低，且不含 Irgafos^® 168，有助於細胞健康生長。

我們的 PureFlex™ 薄膜用於構建 Mobius^® 單次使用 2D 和 3D 袋組件。PureFlex™ 和 PureFlex™ Plus 薄膜均由單一液體接觸層組成，具有低抽取性、耐化學材料和零動物衍生成分，可在整個一次性使用製造過程中提供您所需的靈活性和穩定性。

對 Ultimus^® 薄膜有任何疑問？請聯絡我們的技術專家。

聯絡我們的技術專家

Mobius^® Single-use Assemblies are supported by the Emprove^®計劃的支援 - 掌握合規性與控制的智慧之道

為了補充我們的產品組合，Emprove^{®可方便地存取 Emprove^® 檔案中的可靠技術、法規和供應資訊，以支援您的風險評估連續性。我們的進階驗證檔案會針對您的單次使用組件客制化特定資訊。}

生物製程風險減緩

我們擁有全球性的銷售開發專家和工程師網絡，可為您提供系統展示、設計和實施、規模製程模擬和可行性研究，以及驗證研究和文件編制等服務，並由 Millipore^® 驗證服務。

相關資源

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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相關網路研討會

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

網路研討會：歐盟 GMP 附件 1 草案 - 一次性使用系統的封閉式系統設計考量

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

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

網路研討會：一次性使用製造過程中的萃取物和浸出物等法規考慮因素

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

網路研討會：即將舉行的 USP 665 - 單次使用系統表征等級的今天和明天

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

網路研討會：製程設備特性分析 - 標準化的可萃取物數據如何支援 E&L 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.

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

網路研討會：使用多重單用途系統的挑戰：功能性與可萃取物和可浸出物的對比

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

網路研討會：BPOG 可提取物數據在有效採用一次性使用系統中的作用

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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