KS P ISO 13408-3-2010 Aseptic processing of health care products－Parts 3：Lyophilization《卫生保健产品的无菌工艺 第3部分 冻干法》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 134083 3： KS P ISO 134083 :2010 2010 12 30 http:/www.kats.go.krKS P ISO 134083:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 134083:2010 i ii .1 1 1 2 1 3 .1

2、4 1 4.1 .2 4.2 2 4.3 2 4.4 / 2 5 .2 6 .2 7 3 7.1 .3 7.2 3 7.3 4 7.4 5 7.5 5 7.6 .5 7.7 6 8 .6 8.1 .6 8.2 .6 8.3 .6 8.4 .7 8.5 .8 8.6 8 8.7 .9 9 .10 9.1 .10 9.2 10 9.3 .10 9.4 10 9.5 .10 9.6 .10 11 KS P ISO 134083:2010 ii . . , , . , , . KS P ISO 134083:2010 3： Aseptic processing of health care produ

3、ctsParts 3：Lyophilization 2006 1 ISO 134083, Aseptic processing of health care productsPart 3：Lyophilization , . 1 , , . / . 2 . . ( ) . KS P ISO 134081, 1： KS P ISO 134084, 4：CIP(clean-in-place) KS P ISO 134085, 5：SIP(sterilization in place) KS Q ISO 9001, 3 KS P ISO 134081 . 3.1 (lyophilization) -

4、 3.2 (leak test) 4 KS P ISO 134083:2010 2 4.1 4.1.1 KS P ISO 134081 . 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 . , . a) , b) 5.2 , . 6 6.1 . 6.2 . KS P ISO 134083:2010 3 . 6.3 , . , , . a) b) c) 6.4 , . 6.5 . 6.6 . a) b) (unloading) ( )

5、c) d) , , (placing devices), 6.7 CIP(clean-in-place) SIP(sterilization in place) . KS P ISO 134084 KS P ISO 134085 . 7 7.1 7.1.1 . . 7.1.2 / . /, . 7.2 7.2.1 . 7.2.2 , , , . CIP SIP KS P ISO 134084 KS P ISO 134085 . 7.2.3 , (loading) . 7.2.4 (chamber) KS P ISO 134083:2010 4 . 7.2.5 , , , , . ( ) , .

6、 7.2.6 . 7.2.7 , . 7.2.8 . 7.2.9 , , . a) b) 7.3 7.3.1 7.3.1.1 . 7.3.1.2 , . . 7.3.1.3 . 7.3.1.4 . 7.3.2 7.3.2.1 . . 7.3.2.2 . KS P ISO 134083:2010 5 7.3.2.3 / . 7.4 . 7.5 7.5.1 CIP CIP KS P ISO 134084 . 7.5.2 7.5.2.1 . 7.5.2.2 , . , . 7.5.3 SIP 7.5.3.1 KS P ISO 134085 . 7.5.3.2 (campaign) . . 7.5.3

7、.3 , . 7.5.3.4 , , . 7.6 7.6.1 . , , . 7.6.2 . . 7.6.3 , , . KS P ISO 134083:2010 6 7.7 7.7.1 . 7.7.2 , , ( ), . 8 8.1 , . , . , , , . , , . 8.2 , , . KS Q ISO 9001 . , , . 8.3 8.3.1 “ ” . 8.3.2 8.3.2.1 . 8.3.2.2 . 8.3.2.3 . 8.3.2.4 , , ( ) . 8.3.2.5 . 8.3.2.6 8.3.2.4 8.3.2.5 . KS P ISO 134083:2010

8、7 8.3.3 . 8.3.4 . 8.4 8.4.1 . 8.4.2 . . 8.4.3 . , (jacket) . 8.4.4 . 8.4.5 . . 8.4.6 . 8.4.7 . 8.4.8 CIP KS P ISO 134083:2010 8 KS P ISO 134084 . 8.4.9 SIP KS P ISO 134085 . 8.4.10 , , . 8.4.11 8.4.11.1 . . 8.4.11.2 . 8.5 8.5.1 . . (placebo) . 8.5.2 8.5.2.1 . 8.5.2.2 . 8.5.3 SIP KS P ISO 134085 . 8.

9、6 8.6.1 KS P ISO 134083:2010 9 . , . 8.6.2 . CIP KS P ISO 134084 . 8.6.3 1 . 2 , , . 8.6.3.1 , , , , , , . 8.6.3.2 , , . . , . a) b) c) d) ( ). 8.6.4 8.6.4.1 , , . , , , , , ( ) . 8.6.4.2 . 8.7 , , , . . KS P ISO 134083:2010 10 9 9.1 . 9.2 9.2.1 . 9.2.2 . . a) b) c) d) 9.3 , . a) b) c) d) , 9.4 9.4.

10、1 . 9.4.2 . 9.5 . 9.6 9.6.1 , , , . , , . 9.6.2 . KS P ISO 134083:2010 11 1 KS Q ISO 9000, 2 KS P ISO TS 11139：2009, 3 KS P ISO 13485, 4 U.S. Food and Drug Administration, 21 CFR Part 210 and Part 211, Current Good Manufacturing Practices for Finished Pharmaceuticals 5 U.S. Food and Drug Administrat

11、ion, 21 CFR Part 11, Electronic records, electronic signature 6 U.S. Food and Drug Administration, Guideline on the General Principles of Process Validation, May 1987 7 U.S. Food and Drug Administration, Guide to Inspections of Lyophilization of Parenterals, 15.02.01 8 EEC Guide to Good Manufacturin

12、g Practice for Medicinal Products, Annex 1, Manufacture of Sterile Medicinal Products 9 ISPE, GAMP 4.0. Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture 10 FISCHER, T., Lyophilizer Qualification: Some Practical Advice, Drugs and the Pharma

13、ceutical Sciences, Vol. 137, FreezeDrying/Lyophilization of Pharmaceutical and Biological Products, 2nd edition, 2004, pp. 517533, Marcel Dekker 11 PDA, Process Simulation Testing for Aseptically Filled Products, PDA Technical Report No. 22, 1996 12 JENNINGS, T.A., Validation of the Lyophilization P

14、rocess, Validation of Aseptic Pharmaceutical Processes, 1986, pp. 595-633, Marcel Dekker 13 CAMERON, P., Good Pharmaceutical Freeze-Drying Practice, 1999, Chapter 9, Interpharm Press, Denver, CO 14 JENNINGS, T.A., Lyophilization Introduction and Basic Principles, 1999, Chapter 8, Interpharm Press, D

15、enver, CO 15 AUTERHOFF, G., EG-Leitfaden einer Guten Herstellungspraxis fr Arzneimittel, 5th edition, 1998, ECV-Verlag, Aulendorf 16 OETJEN, G.-W., Gefriertrocknen, 1997, VCH Verlagsgesellschaft, Weinheim 3： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 134083 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Aseptic processing of health care products Parts 3 ：Lyophilization ICS 11.080.01 Korean Agency for Technology and Standards http:/www.kats.go.kr