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pore size 20nm ÀÎ PES (polyethersulfone) ÀçÁúÀÇ virus retentive filter |
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upstream ¿¡¼ chemically defined cell culture media ¸¦ virus filtration Çϴµ¥ »ç¿ë
(media ¸¦ filtration ÇÑ ´ÙÀ½ bioreactor ¿¡ ³Ö°í ¹è¾ç ½ÃÀÛ) |
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Virosart Media ´Â chemically defined cell culture media ÀÇ filtration ¿¡ ÃÖÀûÈ µÇ¾î ÀÖ¾î
monoclonal antibody ¿Í recombinant protein ÀÌ filter ¿¡ ¹¯¾î³ª´Â Çö»óÀÌ ¾ø´Ù. |
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°ËÁõµÈ virus Á¦°Å´É·Â (LRV)
- MVM (minute virus of mice) °ú °°Àº small non-enveloped virus (20nm) : ¡Ã4 log10
- MuLV (murine leukemia virus) ¿Í °°Àº larger enveloped virus (50nm) : ¡Ã6 log10 |
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¸Å¿ì ºü¸¥ filtration ´É·Â ( ¡Ã1000L/m©÷ in 4h) :
Á¦°ö¹ÌÅÍ Å©±âÀÇ filter ´Â 4½Ã°£¾È¿¡ 1000 Liter ÀÌ»óÀÇ cell culture media ¸¦ filtration ÇÒ Á¤µµÀÇ ¸Å¿ì ºü¸¥
flow rate ¿Í capacity |
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media ¿¡ poloxamer (ºñÀ̿¼º °è¸éȰ¼ºÁ¦·Î »ç¿ëµÇ´Â ÁßÇÕü) °¡ ÀÖÀ¸¸é
Virosart¢ç Media filter ÀÇ filtering ¼Óµµ°¡ ¸¹ÀÌ ¶³¾îÁö°Ô µÈ´Ù.
ÀÌ °æ¿ì¿¡´Â Sartopore 2 XLM À» pre-filter ·Î »ç¿ëÇϸé filtering ¼Óµµ°¡ »¡¶óÁø´Ù |
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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¡ compacr ÇÏ°Ô µÈ´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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- Bubble Point Test & Diffusion Test
- ASTM current F-838 guidelines
- ISO 9001 certified Quality Management System
- WFI quality standards bycurrent USP
- Non pyrogenic by USP Bacterial Endotoxin
- USP Plastic Class VI Test
- Non fiber releasing according to 21 CFR |
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¡Ø |
±âŸ »ó¼¼ÇÑ ³»¿ëÀº ¿µÁøÄÚÆÛ·¹ÀÌ¼Ç Çмú±âȹÆÀ ¹®ÀÇ ¹Ù¶ø´Ï´Ù. |
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