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õϴ Stability Testing Chamber ( è) ü |
1) Ư 뷮 37,500L (⺸ 25/ 60%) Stability Testing Room |
2) 뷮 12,000L ( 30/ 75%) Stability Testing Room |
è Ʈ Ͻð,
è ϰ 뷮 ū
ذ 帮ڽϴ.
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( 밡 60~70% ) |
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1. ü
2. Ϲ èδ ̻ ذå ȵ
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ַ ϰڽϴ. |
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1) |
⺻ Room Size(wdh) : 3m5m2.5m (Volume 37,500L)
: 25 / 60% (⺸ )
( - ICH-Q1A - 2 / 5% ) |
2) |
Ư Room Size(wdh) : 3m2m2m (Volume 12,000L)
: 30 / 75% (ƽþ )
( - ICH-Q1A - 2 / 5% ) |
3) |
USFDA-cGMP 21CFRpart 211, ICH-Q1A~F, MKT, GMP/GLP/USP1079, ICH-Q9, Quality Risk Managemet ؿ ° |

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