# CGpGYGMGxG G>Fþ m 2FûFôFÔFö · 2015-05-12 · # CGpGYGMGxG G>Fþ m 2FûFôFÔFö ! + ï x ß...
Transcript of # CGpGYGMGxG G>Fþ m 2FûFôFÔFö · 2015-05-12 · # CGpGYGMGxG G>Fþ m 2FûFôFÔFö ! + ï x ß...
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SOP
SOP
2014 MS044B
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NASA
NASA
ISO14644 JIS 14698
2012 !!2014 MS044B
16 16 2012 9
1000
EU-GMP
15-20
8
3
0.5 m 5.0 m 0.5 m 5.0 m
A 3520 20 3520 20B 3520 29 352000 2900C 352000 2900 3520000 29000D 3520000 29000
2
ISO
Area of cleanroom (m2)Less than or equal to
Min number of sample locations to be tested NL
1 12 14 2 6 38 410 5 24 628 732 8 36 952 1056 1164 1268 1372 1476 15
104 16104 17116 18148 19156 20192 21 232 22276 23352 24 436 25500 26
PMDA
ISO14644
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100 1,000 cm2
10,000 100,000 cm2
100 cm2
100 1,000 cm2
1,000
1
1.75m2
51
Staphylococcus epidermidisStaphylococcus aureusPseudomonas aeruginosaEscherichia coliSerratia marcessceneBacillus subtiliusSaccharomyces cerevisiaeHansenula anomalaAspergillus terrusPenicillium citrinumPenicillium cyclopium
(0.5 m- 500 m)
0.006 m- 0.03 m) 0.2 m- 2 m)
2014 MS044B
USP1116 NF30
P
0.5 m
100.000500.000
1.000.0005.000.000 100.0007.500.000 1.000.00010.000.000
2014 MS044B
lllHumans as SssssssSources of ParticlesSOIIId
HHHKHHHHHHHHH
172014 MS044B
A B
182014 MS044B
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RCS
2014 MS044B
RCS
RCS
RCS
2014 MS044B
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PET
24
m
5 m
2014 MS044B
26
RCS
ISO JP
APC
25cm2 JP
PET
27
28
PET HOT
29
PET HOT 2
30
31
16s /23s rDNA
Bacillus subtilis
Methylobacterium populi
Paenibacillus illinoisensis
2-5.
32
33
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A A
1. 2. 3.
4. 5. 6.
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D
B
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