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2017³â »õ·ÎÀÌ Ãâ½ÃµÈ ÃֽŠ±â´ÉÀÇ Microfluidizer |
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¸ðµç ÀåÄ¡°¡ ÇϳªÀÇ case ¾È¿¡ ³»ÀåµÇ¾î ÀÛ¾÷À» ¾ÈÀüÇÏ°Ô ÁøÇàÇÒ ¼ö ÀÖ°í ÀåÄ¡µéÀ» ¾ÈÀüÇÏ°Ô º¸È£ÇÒ ¼ö ÀÖ´Ù. |
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7ÀÎÄ¡ ´ëÇü ÅÍÄ¡ ½ºÅ©¸°À¸·Î control |
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¾Ð·Â°ú ¿Âµµ Á¶°Ç ¸ð´ÏÅ͸µ ±â´É |
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»ý¼º ¾Ð·Â ¹üÀ§ : 10,000 to 30,000 psi (689 to 2,068 bar) |
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ÃÖ´ë »ý»ê·® : ÃÖ´ë 1.2 liter / min. (½Ã°£´ç 72¸®ÅÍ) |
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°øÁ¤¿¡ ÇÊ¿äÇÑ ÃÖ¼Ò »ùÇ÷® : 200ml |
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Àåºñ°¡ holding ÇÏ´Â ÃÖ´ë »ùÇ÷® : 180ml |
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Biopharma grade Microfluidizer
- cGMP, ASME, BPE ±âÁØ¿¡ ºÎÇÕÇÏ´Â Àåºñ
- UCIP (Ultra Celaning-in-Place)
- 20Ra surface finish, electro-polishing, passivation
- tiltration for natural drainage
- Diaphragm Valve for drainage
- Diaphragm Pump
- ±âŸ cGMP ±ÔÁ¤¿¡ ÀÇÇÑ ´Ù¾çÇÑ ³»¿ë ÀåÂø |
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CE ±ÔÁ¤¿¡ ¿Ïº®È÷ ºÎÇÕ |
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´ÙÀ̾Ƹóµå ÀçÁúÀÇ Interaction Chamber |
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¼¼¶ó¹ÍÀçÁúÀÇ APM (Auxiliary Processing Module)
- cavitation »ý¼º ¾ïÁ¦ÇÏ¿© è¹ö ¸¶¸ð ¹æÁö ±â´É
- Å« ÀÔÀÚÀÎ °æ¿ì pre-mixing ¿ëÀ¸·Î »ç¿ë |
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Biopharma grade ÀÇ ¿³Ã°¢½Ã½ºÅÛ ³»Àå |
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Biopharma grade ÀÇ Feed pump ³»Àå |
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Biopharma grade ¿ë ¾Ð·Â ÃøÁ¤ ÀåÄ¡ (pressure transducer) ³»Àå |
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Pressure Seal ÀÇ ¸¶¸ð¸¦ ¾ïÁ¦Çϱâ À§ÇÑ Seal Quench |
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¿ÀÀÏÀÇ ¾Ð·Â, ³ôÀÌ, ¿Âµµ¸¦ ÃøÁ¤ÇÏ´Â ¼¾¼µé ³»Àå |
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¸ðµç seal °ú gasket µéÀº Class IV certification |
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product Àº ¿Âµµ¸¦ ÃøÁ¤ÇÏ´Â 2°³ÀÇ Biopharma grade ¿ë RTD ¿Âµµ ¼¾¼ ³»Àå |
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Àåºñ³» ¸ðµç ÃøÁ¤ ÀåÄ¡µéÀÇ °Ë±³Á¤¿¡ ÇÊ¿äÇÑ ¸ðµç document µéÀ» Á¦°ø |
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IQ/OQ document Á¦°ø |
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FAT (Factory Acceptance Testing, Àåºñ °øÀå °Ë¼ö) Á¦°ø |
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°í°´ ÇöÀå¿¡¼ ¼³Ä¡°ü·Ã ´Ù¾çÇÑ Áö¿ø
- ÀåºñÀÇ ¼³Ä¡
- SAT (Site Acceptance Testing, Àåºñ ÇöÀå °Ë¼ö)
- IQ, OQ ½ÇÇà
- Àåºñ À¯Áö º¸¼ö ±³À° |
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