1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 134082 2： KS P ISO 134082 :2010 2010 12 30 http:/www.kats.go.krKS P ISO 134082:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 134082:2010 i ii .1 1 1 2 1 3 .1
2、4 .3 5 3 6 .3 7 .4 7.1 .4 7.2 .5 8 7 9 7 10 8 11 8 12 .9 A() .10 11 KS P ISO 134082:2010 ii . . , , . , , . KS P ISO 134082:2010 2： Aseptic processing of health care productsPart 2：Filtration 2003 1 ISO 134082, Aseptic processing of health care productsPart 2：Filtration , . 1 . , . . ( ) . 2 . . ( )
3、 . KS P ISO TS 11139, KS P ISO 134081：2010, 1： 3 KS P ISO 134081, KS P ISO TS 11139 . 3.1 (bacterial challenge test) 3.2 (bioburden) KS P ISO TS 11139 . KS P ISO 134082:2010 2 3.3 (chemical compatibility) / 3.4 (fibre) 10 ( ) KS I ISO 146441：2007, 2.2.7 3.5 (fibre-releasing filter) (flushing) 3.6 (f
4、ilter) 3.7 (filter assembly) (housing) (holder) . . 3.8 (filter cartridge) . 3.9 (filter equipment) , 3.10 (filtration) / / 3.11 (filtration system) (3.9) 3.12 (fluid) (formulation) KS P ISO 134082:2010 3 . 3.13 (fluid-sterilizing filter) 0.22 m . 3.14 (integrity test) / 3.15 (microorganism) , , . 3
5、16 (nominal pore size rating) 3.17 (worst case) 4 KS P ISO 134081：2010 . 5 5.1 . A.1 . 5.2 . A.2 . 5.3 . . 6 6.1 . KS P ISO 134082:2010 4 . . 6.2 . a) 1) 2) , b) 1) 2) , , . 7 7.1 7.1.1 , , . . a) ( ) , . 1 . 2 / (TOC) . b) / , c) 1) 2) , 3) / 4) 5) 6) 7) 8) d) 7.1.2 . . , 10 7 KS P ISO 134082:2010
6、 5 . . 7.1.3 . . . . 7.1.4 . 7.2 7.2.1 7.2.1.1 , . . 1 ( ) . 2 . 7.2.1.2 . . 7.2.1.3 ( 10 % ) . 7.2.1.4 . a) pH b) c) d) e) / f) / g) h) i) / j) k) / l) m) n) o) , KS P ISO 134082:2010 6 7.2.1.5 . 7.2.2 7.2.2.1 . . . a) ( ) . pH, , , , / b) - c) d) e) a) d) 7.2.2.2 Brevundimonas diminuta( ATCC 19146
7、 DSM 1635) 10 7 . Brevundimonas diminuta . . ( L , ) Brevundimonas diminuta . ( 2 3 ). 7.2.2.3 . a) (batch) . b) , . c) , . d) . 7.2.3 KS P ISO 134082:2010 7 ： . 8 8.1 ( ) . 8.2 . . a) b) c) / d) , / e) (A.1 ) 8.3 . 8.4 . 8.5 . . KS P ISO 134081：2010 14. 8.6 . 8.7 . 8.8 . 8.9 . 10 6 (SAL) . . (steri
8、lization in place) 8.10 . . 9 9.1 . 9.2 . a) b) KS P ISO 134082:2010 8 c) , d) e) f) g) , , 9.3 . 9.4 . 9.5 . . . 10 10.1 . . 10.2 , , . a) b) c) d) , / e) f) g) (, , , , , ) h) i) j) 11 11.1 , . . 11.2 . 11.3 . . KS P ISO 134082:2010 9 12 . a) , b) c) d) ( ) e) , KS P ISO 134082:2010 10 A () A.1 .
9、a) b) / c) ( , ) d) e) ( , ) f) g) h) i) ( , ) / ( ) j) k) l) m) A.2 . a) b) c) d) e) f) - - g) h) i) j) 1 a), b), c) d) . 2 . KS P ISO 134082:2010 11 1 KS I ISO 146441：2007, 1： 2 ASTM F 838, Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
10、3 PDA Technical Report No. 26 Sterilizing Filtration of Liquids, PDA J. Pharmaceut. Sci. Technol., 52, No. 3/May-June 1998, Supplement 1 2： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 134082 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Aseptic processing of health care products Part 2 ：Filtration ICS 11.080.01 Korean Agency for Technology and Standards http:/www.kats.go.kr
