KS P ISO 13408-4-2010 Aseptic processing of health care products－Part 4：Clean-in-place technologies《保健产品的无菌加工 第4部分 就地清洗技术》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 134084 4: CIP(clean-in-place) KS P ISO 134084 :2010 2010 12 30 http:/www.kats.go.krKS P ISO 134084:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 134084:2010 i

2、 ii .1 1 1 2 1 3 .1 4 2 4.1 .2 4.2 2 4.3 .3 4.4 3 5 .3 5.1 3 5.2 CIP 3 5.3 .4 6 .5 6.1 5 6.2 5 6.3 6 7 CIP 6 7.1 6 7.2 .6 7.3 8 8 .8 8.1 8 8.2 CIP 8 8.3 .8 8.4 .8 8.5 .9 8.6 .9 8.7 .10 8.8 10 9 10 9.1 CIP 10 9.2 .10 9.3 CIP 11 9.4 .11 9.5 .11 10 .11 A() 12 A.1 12 A.2 12 A.3 12 B() 13 B.1 1 3 13 B.2

3、(analogue method)13 14 KS P ISO 134084:2010 ii . . , , . , , . KS P ISO 134084:2010 4：CIP(clean-in-place) Aseptic processing of health care products Part 4：Clean-in-place technologies 2005 1 ISO 134084, Aseptic processing of health care productsPart 4：Clean-in-place technologies , . 1 CIP(clean-in-p

4、lace) , , . CIP . . GMP / . 2 . . ( ) . KS P ISO 134081, 1： ISO/IEC 90003, Software engineeringGuidelines for the application of ISO 9001：2000 to computer software 3 KS P ISO 134081 . KS P ISO 134084:2010 2 3.1 (cleaning agent) , 3.2 CIP (clean-in-place) CIP . 3.3 (dead leg) 3.4 (design qualificatio

5、n) , 3.5 (material safety data sheet) MSDS , 3.6 (worst-to-clean) , , 4 4.1 4.1.1 KS P ISO 134081 . 4.1.2 , , CIP . 4.1.3 . 4.1.4 , , . 4.2 4.2.1 . KS P ISO 134084:2010 3 4.2.2 . 4.3 , , CIP CIP . , . 4.4 4.4.1 . 4.4.2 . 5 5.1 5.1.1 CIP . a) b) c) d) e) ( / ) f) g) h) i) j) k) 5.1.2 . 5.1.3 CIP . .

6、5.1.4 CIP , , . CIP . 5.1.5 . . . 5.2 CIP KS P ISO 134084:2010 4 5.2.1 . . . / . 5.2.2 , , , , , , . . 5.3 5.3.1 CIP 5.3.1.1 . , , , . , , , . 5.3.1.2 . a) b) ( , , ) c) , , d) e) ( ) f) ( , , , , , , ) g) h) 5.3.1.3 . a) ( ) b) c) , d) e) f) / g) 5.3.2 CIP 5.3.2.1 CIP KS P ISO 134084:2010 5 . . a)

7、b) c) d) ( ) 5.3.2.2 . a) b) c) , , d) e) , CIP CIP . f) / 5.3.3 , . 6 6.1 6.1.1 . . a) b) c) d) 6.1.2 . , , , , , . 6.2 , . . a) KS P ISO 134084:2010 6 b) c) d) 6.3 6.3.1 . 6.3.2 . 7 CIP 7.1 7.1.1 . 7.1.2 5.2 . . . a) b) c) d) , CIP , / / e) f) g) 7.1.3 . . (indicator products) , CIP . 7.2 7.2.1 .

8、7.2.2 . A . KS P ISO 134084:2010 7 1 , . 2 HPLC, TLC, TOC, UV , PH, , , , , / . 7.2.3 . ( ) . . 7.2.4 . . . , CIP . 7.2.5 . . 7.2.6 . CIP . . a) , b) , TOC . B . 7.2.7 7.2.7.1 CIP CIP . 7.2.7.2 () . 7.2.7.3 CIP . 7.2.8 7.2.8.1 CIP . KS P ISO 134084:2010 8 7.2.8.2 . 7.2.9 CIP . , . ( ) . 7.3 CIP . .

9、8 8.1 . . , , . . 8.2 CIP CIP (7. ). 8.3 CIP . , , , . 8.4 8.4.1 CIP CIP . 8.4.2 8.4.2.1 . a) . b) . KS P ISO 134084:2010 9 c) . 8.4.2.2 , , ( ) . . 8.4.2.3 ISO/IEC 90003 . 8.5 8.5.1 CIP . 8.5.2 . . a) b) c) , d) , e) 8.5.3 CIP (, ) CIP . 8.6 8.6.1 . 8.6.2 CIP , / . CIP . 8.6.3 CIP . CIP CIP . , , .

10、 8.6.4 ( CIP ) . CIP . KS P ISO 134084:2010 10 8.6.5 CIP . 8.6.6 . CIP . . 8.7 8.7.1 , , . . 8.7.2 . CIP . 8.7.3 . , . 8.7.4 . 8.8 8.8.1 CIP . 8.8.2 CIP . . 8.8.3 . 9 9.1 CIP CIP . CIP . 9.2 . . a) b) c) d) , e) CIP KS P ISO 134084:2010 11 9.3 CIP 9.3.1 CIP . a) b) CIP () c) d) CIP , , , , . 9.3.2 CIP . 9.4 9.4.1 , , CIP . 9.4.2 , . 9.4.3 . 9.5 . 10 10.1 . 10.2 . a) CIP b) , c) d) CIP . KS P ISO 134084:2010 12 A () A.1 . ( , ) . . . . A.2 . . A.3 , . / . KS P ISO 134084:2010 13 B () B.1 1 3