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Blood ¿Í Plasma ¿¡¼ virus ¸¦ Á¦°ÅÇϱâ À§ÇØ »ç¿ëµÇ´Â filter |
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Plasma derivatives (Ç÷ÀåºÐȹÁ¦Á¦) ÀÇ filtration À» À§ÇØ °³¹ßµÈ virus filter |
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membrane Ç¥¸éÀ» Ä£¼ö¼ºÀ¸·Î ó¸®ÇÑ modified hydrophilic PES (polyethersulfone) ÀçÁú·Î µÈ ¹ÙÀÌ·¯½º Á¦°Å¿ë ÇÊÅÍ |
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Ä£¼ö¼º PES membrane Àº ´ÙÀ½ÀÇ Æ¯Â¡À» °¡Áø´Ù.
- membrane ÀÌ ¹°¿¡ wetting ÀÌ ¸Å¿ì ÀߵȴÙ.
- IVIG (Á¤¸Æ¿ë ¸é¿ª±Û·ÎºÒ¸°) ¿Í °°Àº hydrophobic Ư¼ºÀÇ Ç÷¾×¼ººÐÀÇ È帧ÀÌ ÀÏÁ¤ÇÏ°Ô À¯ÁöµÈ´Ù. |
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Applications :
- IVIG (intravenous immunoglubulin) ¿Í °°Àº hydrophobic feed stream
- plasma derivatives
- hydrophobic antibodies
- hydrophobic recombinant proteins µî¿¡ È¿°úÀûÀ¸·Î ÀÛ¿ë |
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¹ÙÀÌ¿À ÀǾàǰÀÇ »ý»êÀÇ ¸¶Áö¸· ´Ü°èÀÎ purification ´Ü°è¿¡¼ ¹ÙÀÌ·¯½º Á¦°Å¿ëÀ¸·Î »ç¿ë |
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»ý»êÇÏ´Â ÀǾàǰ¿¡ DNA, lipoprotein °ú °°Àº ºÒ¼ø¹°ÀÌ ¸¹À» °æ¿ì¿¡´Â Virosart¢ç Max Pre-Filter ¸¦
¸ÕÀú Åë°úÇÏ°Ô ÇÑ ÈÄ Virosart¢ç HF ¿¡¼ filtration À» ÇÏ°Ô µÇ¸é ¸·Èû¾øÀÌ ¸¹Àº ¾çÀÇ product ¸¦ filtration ÇÒ ¼ö ÀÖ´Ù. |
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PES (polyethersulfone) ÀçÁúÀÇ membrane ÀÌ double layer À¸·Î ÀÌ·ç¾îÁ® ÀÖ´Â virus retentive filter |
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pore size 20nm ÀÎ PES (polyethersulfone) ÀçÁú·Î ÀÌ·ç¾îÁ® ÀÖ¾î ¸¹Àº ¾çÀÇ product ¸¦ ó¸®ÇÒ ¼ö ÀÖ°í
flow rate µµ »¡¶ó filtration ºñ¿ëÀ» ´ëÆø Àý°¨ÇÒ ¼ö ÀÖ´Â virus retentive filter |
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PPV (Porcine parvovirus) ¿Í MVM (minute virus of mice) °ú °°Àº Å©±â°¡ 20nm Á¤µµÀÎ small non-enveloped virus, ±×¸®°í MuLV (murine leukemia virus) ¿Í °°Àº
Å©±â°¡ 50nm ÀÌ»óÀÎ larger enveloped virus ¸¦ Á¦°ÅÇÏ´Â °ÍÀÌ ÁÖ target ÀÎ ÇÊÅÍ |
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Virosart HC ÀÇ ¹ÙÀÌ·¯½º Á¦°Å´É·Â (LRV : Log Reduction Value) :
- ¡Ã4 log10 : small non-enveloped virus (PPM, MVM)
- ¡Ã6 log10 : larger enveloped virus (MuLV) |
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Å©±â°¡ ÀÛ°í flushing volume ÀÌ ÀÛ¾Æ ÀÏȸ¿ëÀ¸·Î »ç¿ëÇϱ⿡ Æí¸®ÇÑ virus Á¦°Å ÇÊÅÍ |
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filter ´Â high packing density ·Î µÇ¾î hold up volume °ú flushing volume ÀÌ ÀÛ°Ô µé°í
filter Àüü ºÎÇǰ¡ compact ÇÏ°Ô µÈ´Ù. |
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¿Ïº®ÇÑ ¸ê±Õ»óÅ·Π°ø±ÞµÇ¹Ç·Î filter ÀÇ ¼³Ä¡°¡ ¸Å¿ì ÆíÇÏ°í »ç¿ëÀÌ ¸Å¿ì Æí¸®ÇÏ´Ù |
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Integrity Testing :
water-based diffusion test ¸¦ ÀÌ¿ëÇÏ¿© integrity test ¸¦ ½ÇÇàÇÏ¿´À¸¸ç
small non-enveloped virus ¸ðµ¨·Î¼ bacteriophage PP7 À» ÀÌ¿ëÇÏ¿© Å×½ºÆ® ÇÑ °á°ú
¡Ã4 log10 ÀÇ LRV °ªÀ» ±¸ÇÒ ¼ö ÀÖ¾ú´Ù. |
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Regulatory Compliance |
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- ISO 9001 certified Quality Management System
- WFI quality standards bycurrent USP
- Non pyrogenic by USP Bacterial Endotoxin
- USP Plastic Class VI |
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¡Ø |
±âŸ »ó¼¼ÇÑ ³»¿ëÀº ¿µÁøÄÚÆÛ·¹ÀÌ¼Ç Çмú±âȹÆÀ ¹®ÀÇ ¹Ù¶ø´Ï´Ù. |
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