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SOP

SOP

2014 MS044B

– :

–

– ...

–

–

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.

:

: ( )

: /

D

B

A!!