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1. Design
The market leaders in conventional bioreactor and aseptic mixing products have clearly perceived the advantages of these single-use bioreactors for decision-makers and managers:
flexibility ;
quick start ;
lower initial capital investment ;
no overcapacity: adapt capacity to demand ;
no cross-contamination ;
no on-site cleaning and sterilization, saving time for operators and money on cleaning and disinfection products and purified water;
lower development costs ;
shorter time-to-market.
For users, however, a number of risks remain:
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Design
Performance
Bibliography
Standards and norms
Biocompatibility standards
ISO 10993-5: Biological Evaluation of Medical Devices – In Vitro Cytotoxicity
US Pharmacopeia <87> : Biological Reactivity test, In Vitro
US Pharmacopeia <88> : Biological Reactivity Test, In Vivo
European Medicines Agency A410_01 (rev2) or European Pharmacopoeia 5.2.8 : Minimizing the Risk of...
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Statistical and economic data
Market
The single-use bioreactor market was valued at €190.4 million in 2014, with expected growth of 18.4% a year to €424 million by 2019.
Bioprocessing news: Single-use bioreactor market to grow ALLpaQ Packaging Group January 29, 2015
Single-Use bioreactors for Pharma World market 2013-2023 Vision gain 03.06.2013
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