With the continuous development and growth of biopharmaceuticals, the requirements for disposable bioprocess system consumables used in the entire biological preparation process are also gradually improving and maturing. Guangyan New Materials provides disposable preparation, storage, and pipeline connection solutions for bioprocesses to support the pharmaceutical companies' needs for process liquid treatment during the production process and meet the pharmaceutical companies' requirements for disposable bioprocess systems, such as better products, quality, and price.
Preparation and storage of buffers and culture media
Collection of bioprocess intermediates
Intermediate product storage
Stock solution harvesting and storage
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Physical and chemical properties |
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Test items |
Test standards |
Test results |
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Connection firmness |
Internal methods |
Meet the requirements |
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Heat seal strength |
YBB00122003-2015 |
Meet the requirements |
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Leak test |
Internal Standard |
Meet the requirements |
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Insoluble particles |
YBB00272004-2015 |
Meet the requirements |
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Biological performance |
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Test items |
Test standards |
Test results |
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bacterial endotoxins |
Chinese Pharmacopoeia |
Meet the requirements |
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Sterility |
Chinese Pharmacopoeia |
Meet the requirements |
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Cytotoxicity test |
ISO 10993-5 |
Meet the requirements |
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Skin irritation test |
ISO 10993-23 |
Meet the requirements |
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Sensitization test |
ISO 10993-10 |
Meet the requirements |
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Acute systemic toxicity test |
ISO 10993-11 |
Meet the requirements |
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Pyrogen test |
ISO 10993-11 |
Meet the requirements |
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