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, , F F 0,9 % 400

26 2008 10:36

generationP

. F 15 . ( 400 ). F 15 . , 3 , , ( FDA). , F 3 , . , , .
, OQ , , .
F , 121 z=10. - .

28 2008 13:36

DN

, - . , F? - ? EMEA Decision tree , , 121 15 , F0 . , , /, . - 121 0,2511 115 .., F0=15, , , 121 15 . - , , , () , , , - , , " " ( ). , , - ( )... , ..... -

01 2008 08:41

generationP

, ...
121 15. , 15 . SAL (Sterility Assurance Level), 10 -6. , , 1000000 . 15 . 121 2 ( D) ( 10 ). (2+2+2+2+2+2)+3=15 2*6+3=15. , SAL 12 3 " ". , F0 .

01 2008 09:42

DN

D = t/ (Log10 N0- Log10 Nt )
է t C ӧ֧ާ ӧ٧է֧ۧӧڧ ֧ݧ
N0 C ߧѧѧݧߧѧ ݧڧ ާڧܧԧѧߧڧ٧ާ
Nt C ܧߧ֧ߧѧ ݧڧ ާڧܧԧѧߧڧ٧ާ

ڧ٧ڧ֧ܧڧ ާ: D C ӧ֧ާ, ٧ ܧ ݧڧ ާڧܧԧѧߧڧ٧ާ ֧է֧ݧקߧ ݧӧڧ ߧڧ٧ڧ 10 ѧ (ߧ էڧ Log), .. ԧڧҧߧ֧ 90% ާڧܧԧѧߧڧ٧ާ ٧ѧԧ٧ܧ
֧ݧڧڧߧ D ڧާ֧֧ ާ ݧܧ ֧է֧ݧקߧߧ ֧ާ֧ѧ, ߧѧڧާ֧ D121.... ԧ ԧӧ էݧ ܧߧܧ֧ߧ ݧڧ ާڧܧԧѧߧڧ٧ާ

Z=(T2-T1)/(LogD1-LogD2)
է
- D1 C ӧ֧ݧڧڧߧ D էݧ ާڧܧԧѧߧڧ٧ާ ֧ާ֧ѧ T1
- D2 - ӧ֧ݧڧڧߧ D էݧ ާڧܧԧѧߧڧ٧ާ ֧ާ֧ѧ T2

ڧ٧ڧ֧ܧڧ ާ: Z C ֧ݧڧڧߧ tC, ߧ֧ҧէڧާѧ էݧ ڧ٧ާ֧ߧ֧ߧڧ ٧ߧѧ֧ߧڧ D 10 ѧ (ڧݧ ߧ էڧ ݧԧѧڧ)... ѧܧا ڧާ֧֧ ާ էݧ ܧߧܧ֧ߧ ݧڧ ާڧܧԧѧߧڧ٧ާ

L = Log-1((T0-Tb)/z)=10T0-Tb/z
է
0 C ֧ާ֧ѧ ާѧ֧ڧѧݧ ٧ѧԧ٧ܧ
b C ֧ݧѧ֧ާѧ (֧֧֧ߧߧѧ) ֧ާ֧ѧ ֧ (ߧѧ. 121㧳)
Z C ֧ާ֧ѧߧ ڧߧܧ֧ާ֧ߧ, ڧ٧ާ֧ߧڧ ӧ֧ݧڧڧߧ D 10 ѧ

ڧ٧ڧ֧ܧڧ ާ: L C ܧ ݧ֧ѧݧߧ, ڧӧ֧էקߧߧѧ ܧӧڧӧѧݧ֧ߧߧ ѧߧէѧߧ ܧ ֧է֧ݧקߧߧ ֧ާ֧ѧ (ܧӧڧӧѧݧ֧ߧ ާڧߧѧ ӧ֧ާ֧ߧ ߧѧاէ֧ߧڧ ҧѧ٧ ֧ާ֧ѧ Tb)
T
Fn = L dt
T1
ڧ٧ڧ֧ܧڧ ާ: ާ ާԧߧӧ֧ߧߧ ٧ߧѧ֧ߧڧ L (F0) ٧ѧէѧߧߧ էڧѧѧ٧ߧ ֧ާ֧ѧ, ڧݧ ܧӧڧӧѧݧ֧ߧߧ ӧ֧ާ ߧѧاէ֧ߧڧ ާѧ֧ڧѧݧ ٧ѧԧ٧ܧ ֧֧֧ߧߧ ֧ާ֧ѧ (ݧѧէ ܧڧӧ ߧ ԧѧڧܧ ֧ާ֧ѧ / ӧ֧ާ)
1 ާڧߧ 114㧳 = 0,2 ާڧ. 121㧳 ֧ݧ z=10

F0/D121 = Log10A C Log10B

է ާاߧ ӧѧ٧ڧ Fo ܧѧ ڧߧ֧ԧѧ ٧ ާ֧ا ӧ֧ާ֧ߧ - 10 ֧֧ߧ ѧܧڧ֧ܧѧ ֧ާ֧ѧ ާڧߧ ҧѧ٧ӧѧ ֧ާ֧ѧ ֧ڧݧڧ٧ѧڧ է֧ݧקߧߧѧ ߧ Z ҧ֧ܧߧ֧ߧ ާѧݧ ֧٧ܧѧ ӧ֧ާ֧ߧ... ѧܧڧ֧ܧ ӧڧݧ֧ ߧ ѧܧڧܧ ܧߧ֧ߧ ֧٧ܧѧ, ҧݧڧ ڧҧݧڧا֧ߧڧ֧ ާاߧ ӧڧݧ ߧѧڧާ֧ ܧѧ ֧էߧ֧ ٧ߧѧ֧ߧڧ ֧ާ֧ѧ ٧ 2 ֧ܧߧէ... ߧ ֧ݧ ߧ֧ ߧާѧݧߧ ڧҧ ڧ ѧݧڧէѧ

ѧ էѧݧ֧.... ڧߧާ ݧӧѧާ ӧ ٧ѧӧڧڧ ֧ާۧܧ ݧڧ, ӧߧ ާڧܧҧڧݧԧڧ֧ܧ ߧѧԧ٧ܧ ߧ ާѧ֧ڧѧݧ ٧ѧԧ٧ ֧ڧݧڧ٧ѧ ֧֧ ߧѧѧݧ ڧܧݧ ֧ڧݧڧ٧ѧڧ.... ާڧڧܧ ߧڧܧѧܧ ߧ֧. ݧ ܧѧ ڧڧ, ӧ է ӧѧݧڧէѧڧ ڧ٧ڧ֧ܧڧ, .. ڧ٧ާ֧֧ߧڧ ֧ާ֧ѧ, ѧѧ է ԧҧ ާڧܧҧڧݧԧڧ֧ܧڧ, ߧӧ ӧѧݧڧէѧڧ ѧӧݧ ڧݧ֧էӧѧߧڧ ѧܧڧ֧ܧ ֧ܧڧӧߧ ֧ڧݧڧ٧ѧڧ ֧ڧѧݧߧ ڧԧӧݧ֧ߧߧ ҧڧڧߧէڧܧѧ.... 15 ާڧߧ 121 ԧѧէ ڧ ӧէ ާڧڧ֧ܧѧ ӧ֧ݧڧڧߧ, ѧ ا, ܧѧ էݧ է֧ڧԧ֧ߧڧ٧ѧڧ Z=46,4, ѧӧ֧էݧڧӧ ѧէ ߧاߧ ܧѧ٧ѧ, ާاߧ ݧڧ ߧէܧڧߧ ҧݧڧ ٧ߧѧ֧ߧڧ֧ Z, էӧէߧ ԧ֧ۧ٧֧ѧ ֧֧ԧ֧ ӧէ ߧ ԧݧҧڧߧ ߧ֧ܧݧܧڧ ܧڧݧާ֧ اڧӧ ާڧܧԧѧߧڧ٧ާ.....

01 2008 14:07

DN

... .... ...

01 2008 14:08

generationP

http://wwwapp1.fda.moph.go.th/drug/zone_gmp/files/Heat_sterilize_validation2.pdf

!!!!!!!!!!

01 2008 14:35

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