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Merck
CN

SAU0200L41DP5

Mobius®标准袋子,200 L,银色,PureFlex膜,桶组件

200L Standard PureFlex Drum Assembly

别名:

Mobius®桶式袋子,silver

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eCl@ss:
32031690
UNSPSC Code:
23151806
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material

PureFlex container, PureFlex film

Quality Level

sterility

sterile; γ-irradiated (Sterilized using a validated gamma irradiation level of 25-40 kGy)

product line

EMPROVE® Single Use, Mobius®

parameter

200 L sample volume

fitting

(1/2 in. MPX Coupling Body, 1/2 in. MPX Sealing Plug, Pinch Clamp, Cable Tie)

application(s)

pharmaceutical

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General description

Mobius® standard drum assemblies are reliable, ready-to-use fluid storage and processing solutions for biopharmaceutical applications. These convenient single-use systems feature pre-sterilized PureFlex film containers available in 50 L to 200 L volumes. Designed to fit Mobius® polyethylene drums and other commercial storage drums, these assemblies minimize operator error and process risks while maximizing operational efficiency in bioprocessing workflows.

Application

Mobius® standard drum assemblies are ideal for buffer storage, media preparation, intermediate product holding, and general fluid transfer operations in biopharmaceutical manufacturing processes.

Features and Benefits

  • Flexible
  • Easy to set up and use
  • Mobius® Silver Certification
  • Sterilized using gamma irradiation
  • Excellent gas barrier performance

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MOBIUS is a registered trademark of Merck KGaA, Darmstadt, Germany
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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Key aspects of single-use assembly qualification including quality by design (QbD), quality risk management (QRM) and operator handling and training.

Before adoption of single-use technologies in biomanufacturing, manufacturers must assess the risk to the drug product from potential leachables. This article highlights a general approach based on the United States Pharmacopeia (USP).

This page provides an overview of USP <87>, <88>, and <1031>, compares bioreactivity testing, and describes the transition of our organization towards in vitro test methods.

Our global network of raw material suppliers and regional production sites for single-use technologies ensures business continuity for biopharma customers.

我们的科学家团队拥有各种研究领域经验,包括生命科学、材料科学、化学合成、色谱、分析及许多其他领域.

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