滅菌バリデーション基準の制定について（PDF：387KB）
Contents
1. I VD 1 2 27 11 24 32. 3 DBe Cc SAL Sterility Assurance Level alae 1 10 4 10 NN 5 10 Installation Qualification 2 6 0Q Operational Qualification
3. Yee NM HOGAN 3 4 TQ 5 0Q 8 6 PQ 1Q 0Q
4. 3 ye eS EY ZY Se A 12 1 2
5. 5 12 13 14 15 16
6. A 2
7. A 7 35 145 80 2 9 80 2 5 9 12 4
8. 4 1 2 A ae 3
9. 2 7 PQ Performance Qualification 2 8 2 9 10 11
10. A 5 5 1 Rev 2 3 4 6 1 2
11. 7 1 2 cue 3 4 Bik 7 EE AD ARMED DIAL IC UWBICIS UCR LES 8 1 2 OA a 1 BEAU PSP Ya VERSES NFS IGE CRT SOL Bia
12. 3 1 FRA JIS T 0801 1 2010 ISO 11135 1 2007 1 2 JIS T 0806 1 2010 ISO 11137 1 2006 1 JIS T 0806 2 2014 ISO 11137 2 2013 T1S0 TS 13004 2013 2 3 JIS T 0816 1 2010 ISO 17665 1 2006 1 3 1 9 2
13. 4 HS AN 3 4 A 5 A ids Diets
14. d Ae 1 1 QMS 2 QMS 2 J I S
15. 1218 4 26 12 18 FF amp 16 169 QMS 45 46 17 3 0 0330001 GMP QMS 4 4 MR QMS
16. GE ANGE Th seer A PQ 8 PQ 7 1Q 0Q PQ 10 8 9 11 1 Ge 2
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