| 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 | ![]() |
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