KS P ISO 8362-5-2009 Injection containers and accessories－Part 5：Freeze drying closures for injection vials《注射容器和附件 第5部分 注射瓶用冷冻干燥塞》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 83625 5： KS P ISO 83625 :2009 2009 12 17 http:/www.kats.go.krKS P ISO 83625:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 12 18 ：2009 12 17 2009-0823 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 83625:2009 i ii 1 1 2

2、 1 3 .1 3.1 (freeze drying; lyophilization)1 3.2 (freeze drying closure).2 4 .2 5 3 6 4 7 4 7.1 .4 7.2 .4 7.3 .5 7.4 .5 8 5 A() .6 A.1 .6 A.2 .6 A.3 .6 A.4 .6 A.5 .7 A.6 .8 9 KS P ISO 83625:2009 ii 2008 2 ISO 83625, Injection containers and accessoriesPart 5： Freeze drying closures for injection via

3、ls . ISO 8362 . 1： 2： (KS P ISO 83622 ) 3： (KS P ISO 83623 ) 4： (KS P ISO 83624 ) 5： (KS P ISO 83625 ) 6： - (KS P ISO 83626 ) 7： - (KS P ISO 83627 ) KS P ISO 83625:2009 5： Injection containers and accessories Part 5：Freeze drying closures for injection vials 1 ISO 83621 KS P ISO 83624 , , , , . . .

4、, , . 2 . . ( ) . KS M ISO 48, (10 IRHD 100 IRHD ) KS M ISO 33021, 1： KS M ISO 33022, 2： KS M ISO 76191, 1：( ) ISO 88711, Elastomeric parts for parenterals and for devices for pharmaceutical usePart 1： Extractables in aqueous autoclavates ISO 88714, Elastomeric parts for parenterals and for devices

5、for pharmaceutical usePart 4： Biological requirements and test methods ISO 88715：2005, Elastomeric parts for parenterals and for devices for pharmaceutical usePart 5： Functional requirements and testing 3 . 3.1 (freeze drying; lyophilization) KS P ISO 83625:2009 2 3.2 (freeze drying closure) 4 4.1 1

6、 , 1 . h 1 , . 1 (positioning element) 2 a (lumen) . 1 KS P ISO 83625:2009 3 1 ：mm d 10.2 d 2 a h 20.25 h 3 h 4 13 12.5 7.5 2.0 2.0 1.8 20 18.8 13.0 3.3 2.0 2.0 ad 2 h 3 . 4.2 , KS M ISO 33021 KS M ISO 3302 2 . 4.3 , ( 1 ). 0.3 mm . 1 , . (mark) . 4.4 , 0.3 mm . 1 d 1 . 4.5 , () . 4.6 , . 4.7 (pierc

7、ing) . , . 4.8 . 4.9 , , . 5 “ ”, , . 13 . KS P ISO 8362513 KS P ISO 83625:2009 4 6 7. . (1212) 30 , 2 . ( , ) . , (7.2.7 ). , . 7 7.1 7.27.4 . 7.2 7.2.1 KS M ISO 48 , 5 IRHD . , KS M ISO 3302 . 7.2.2 ISO 88715：2005, 4.1 . 7.2.3 ISO 88715：2005, 4.2 . 7.2.4 ISO 88715：2005, 4.3 . 7.2.5 ISO 88715：2005,

8、 4.4 . 7.2.4 . 7.2.6 KS P ISO 83625:2009 5 . , . , ISO 2230 . 7.2.7 . 7.3 ISO 88711 . 7.4 ISO 88714 . 8 5. . KS P ISO 83625:2009 6 A () A.1 . . A.2 A.2.1 A.2.2 , 110 150 . A.2.3 , . . A.2.4 A.2.5 , 0.1 mg . A.3 A.3.1 , () A.3.2 (control solution), 1 %() A.4 A.4.1 . (1402) . . 80 , / . KS P ISO 83625

9、:2009 7 A.4.2 A.4.2.1 . , . (232) , (505) %, ISO 554 . A.4.2.2 10 4 mm 7 mm ( A.1 ). 0.1 mg . (A.6 ). A.1 A.4.3 . 90 . . A.5 A.5.1 (extrapolation) A.2 . 90, 85, 80, 75, 70 . A.2 1 (：g) . KS P ISO 83625:2009 8 X () Y ( g) a b A.2 / A.5.2 W %(m/m) . 10 2 1 m m W (A.1) m 1： (： g) m 2： (：mg) A.6 A.6.1 .

10、 (back-extrapolation) . . A.6.2 500 g3 000 g 200 mg400 mg . 0.1 %1.5 % . X Y a b KS P ISO 83625:2009 9 1 ISO 554, Standard atmospheres for conditioning and/or testingSpecifications 2 ISO 2230, Rubber productsGuidelines for storage 3 ISO 15378, Primary packaging materials for medicinal productsPartic

11、ular requirements for the application of ISO 9001：2000, with reference to Good Manufacturing Practice(GMP) 5： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 83625 :2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Injection containers and accessories Part 5：Freeze drying closures for injection vials ICS 11.040.20