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
Application
Features and Benefits
- Flexible
- Easy to set up and use
- Mobius® Silver Certification
- Sterilized using gamma irradiation
- Excellent gas barrier performance
Legal Information
商品
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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