GOST R ISO 13408-4-2011 Aseptic processing of health care products Part 4 Clean-in-place technologies《保健品无菌加工 第4部分 清洗技术》.pdf

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1、 4 ISO 13408-4:2005Aseptic processing of health care products Part 4: Clean-in-place technologies(IDT) 13408-42011 27 2002 . 184- , 1.02004 . 1 - () , 42 458 - 3 7 2011 . 731-4 13408- 4:2005 . 4. (ISO 13408-4:2005 Asepticprocessing of health care products Part 4: Clean-in-place technologies). - , 5

2、 , - . () . - , , 2012 , - - II 13408-420111 12 13 14 24.1 .24.2 24.3 24.4 - 25 .25.1 .25.2 35.3 .36 .46.1 46.2 56.3 57 (CIP ) .57.1 .57.2 57.3 .68 .68.1 .68.2 78.3 ()78.4 .78.5 78.6 78.7 .88.8 .89 .89.1 89.2 89.3 99.4 99.5 () 910 .9 () 10 B () ( ) . 11 () 11 12 13408-42011III 13408 : , -, , . , ,

3、 . . - . - , , . - ( 13408-5). , , . , . 13408 / 198 :- 1. ;- 2. ;- 3. ;- 4. ;- 5. ;- 6. .IV 13408-42011 4 Aseptic processing of health care products. Part 4. Clean-in-place technologies 201212011 (CIP) , - , , , - . , , . . , . , - (GMP).2 : 13408-1 . 1. (ISO 13408-1, Aseptic processing of health

4、care products. Part. 1. General requirements)/ 90003 . 9001:2000 (ISO/IEC 90003, Software engineering Guidelines for the application of ISO 9001:2000 to computer software)3 13408-1, - :3.1 (cleaning agent): , , , .3.2 (clean-in-place CIP): , . CIP , .3.3 (dead leg): , .1 13408-420113.4 () (design qu

5、alification): - , , - .3.5 (material safety data sheet): -, - .3.6 (worst-to-clean): , - . , - , , .4 4.1 4.1.1 13408-1.4.1.2 () , .4.1.3 , , .4.1.4 , , - .4.2 4.2.1 , () - / .4.2.2 , , .4.3 () , , , , . .4.4 - 4.4.1 () - - .4.4.2 - , .5 5.1 5.1.1 , , :a) , , ;b) ;c) , ;d) , - ;e) ( / );f) ;g) ;h) ;

6、i) ;2 13408-42011j) ;k) - , , .5.1.2 , - .5.1.3 . - .5.1.4 , , . , , , .5.1.5 . - . - ().5.2 5.2.1 , . , . , / - .5.2.2 , -, , , , , - ( ) . , - .5.3 5.3.1 , 5.3.1.1 - . . , , -, . , , () -, (, ) .5.3.1.2 , , -:a) ;b) (, , - );c) , , , - , ;d) ;e) , , ;f) (, , , , , .) ;g) ;h) .3 13408-420115.3.1.3 , , :a) ,

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