针剂车间微生物洁净室主要指标表
2015-06-08
针剂车间微生物洁净室主要指标表
|
房间
|
房间
|
空调系统
|
排风系统
|
房间面
积(m2)
|
房间高度
(m)
|
房间容积
(m3)
|
洁净级别
|
温度℃
|
相对
|
送风
量m3/h
|
回风
量m3/h
|
排风量
m3/h
|
换气次数
|
压力Pa
|
编号
|
名称
|
湿度%
|
1
|
二更(1)
|
JK-2
|
|
2.10
|
2.5
|
5.25
|
C
|
18-26
|
45-65
|
130
|
120
|
|
24.76
|
≥10Pa
|
2
|
缓冲(1)
|
JK-2
|
|
2.10
|
2.5
|
5.25
|
C
|
18-26
|
45-65
|
130
|
120
|
|
24.76
|
≥10Pa
|
3
|
阳性菌对照室
|
JK-2
|
JP-2
|
6.60
|
2.5
|
16.50
|
C
|
18-26
|
45-65
|
500
|
|
550.00
|
30.30
|
≥10Pa
|
4
|
气闸(1)
|
JK-2
|
|
3.30
|
2.5
|
8.25
|
C
|
18-26
|
45-65
|
210
|
200
|
|
25.45
|
≥10Pa
|
5
|
二更(2)
|
JK-1
|
|
2.70
|
2.5
|
6.75
|
C
|
18-26
|
45-65
|
180
|
170
|
|
26.67
|
≥10Pa
|
6
|
缓冲(2)
|
JK-1
|
|
3.30
|
2.5
|
8.25
|
C
|
18-26
|
45-65
|
230
|
220
|
|
27.88
|
≥10Pa
|
7
|
洁净走廊
|
JK-1
|
|
6.58
|
2.5
|
16.45
|
C
|
18-26
|
45-65
|
410
|
400
|
|
24.92
|
≥10Pa
|
8
|
内毒素检测
|
JK-1
|
JP-1
|
4.62
|
2.5
|
11.55
|
C
|
18-26
|
45-65
|
350
|
|
370.00
|
30.30
|
≥10Pa
|
9
|
不溶性微粒
|
JK-1
|
JP-1
|
5.28
|
2.5
|
13.20
|
C
|
18-26
|
45-65
|
420
|
|
430.00
|
31.82
|
≥10Pa
|
10
|
抗生素效价
|
JK-1
|
JP-1
|
6.48
|
2.5
|
16.20
|
C
|
18-26
|
45-65
|
450
|
|
480.00
|
27.78
|
≥10Pa
|
11
|
抗生素检定
|
JK-1
|
JP-1
|
6.48
|
2.5
|
16.20
|
C
|
18-26
|
45-65
|
450
|
|
480.00
|
27.78
|
≥10Pa
|
12
|
无菌室
|
JK-1
|
JP-1
|
8.64
|
2.5
|
21.60
|
C
|
18-26
|
45-65
|
680
|
|
700.00
|
31.48
|
≥10Pa
|
13
|
气闸(2)
|
JK-1
|
|
1.82
|
2.5
|
4.55
|
C
|
18-26
|
45-65
|
110
|
100
|
|
24.18
|
≥10Pa
|
备注
|
|