1

設(shè)備內(nèi)腔表面粗糙度

/Surface roughness of the inner cavity of equipment

Ra≤0.5um

2

無(wú)菌傳遞總時(shí)間

/Total time of aseptic transfer

100min

3

滅菌總時(shí)間

/Total sterilization time

40min

4

通風(fēng)總時(shí)間

/Total ventilation time

50min

5

滅菌濃度

/Sterilizing concentration

200-500ppm

6

滅菌后殘留VHP濃度標(biāo)準(zhǔn)

/Standard of residual VHP concentration after sterilization

≤1ppm

7

內(nèi)腔材質(zhì)/Inner cavity material

SUS316/T2.0mm

8

設(shè)備外表面材質(zhì)

/External surface material of equipment

SUS304

9

換氣次數(shù)

/Air change times

150-200pcs

10

設(shè)備運(yùn)行階段內(nèi)部潔凈等級(jí)

/Internal cleanliness grade of equipment operation stage

A級(jí)

11

設(shè)備泄露率

/Equipment leakage rate

≤0.5%

12

噪聲級(jí)別

/Noise level

≤75db

13

滅菌效果

/Sterilization effect

VHP發(fā)生器D值開發(fā)設(shè)定（6LOG）

14

總功率(W)

/Total power (W)

≤2000W

15

非金屬材料

/Nonmetallic materials

（PTFE）、Silica   gel、Tempered glass

16

汽化溫度

/Vaporization temperature

≤100℃