醫用氧氣生產和驗證的品質控制

醫用氣體的監管

醫用氣體受美國藥典 (USP)、歐洲藥典 (EP) 和日本藥典 (JP) 的監管,為所有醫用氣體制定標準,包括各種品質、濃度、純度、包裝、標籤和標識的標準。 HORIBA 透過提供廣泛的高精度分析和測量解決方案在該領域做出了貢獻。

歐洲藥典標準

醫院使用的醫用氣體是生命維持元素,直接影響病人生命的維持。因此,在醫用氣體使用的環節,必須是乾淨的、高純度的。對於歐洲藥典指南中嚴格規定了分析方法和濃度。

Medical oxygen gas standards (Prepared with reference to EIGA documents)

Figure 1: Medical oxygen gas standards (Prepared with reference to EIGA documents)

空分裝置製氧工藝

醫用氧氣通常由空氣分離裝置生產。空氣分離設備透過低溫蒸餾將大氣分離成其主要成分:氧氣 (O2)、氮氣 (N2) 和氬氣 (Ar)。利用各成分氣體的沸點差異,在蒸餾裝置中進行空氣的分離。空分裝置生產的醫用氣體透過氣瓶卡車分發給使用者。在分銷之前進行品質保證流程,以確保氧氣產品是否符合要求的標準與規範。

Figure 2: Air Separation Plant

Figure 2: Air Separation Plant (*Images are for illustrative purposes only)

醫用氧氣分析儀技術參數

 Lineup

High Sensitivity Type

Standard Type

Type without Carrier Gas

Model

VA-5003RHVA-5003R

 VA-5006R

Measurement principle

Magneto-pneumatic method

Magneto-pneumatic method

Paramagnetic (Dumbbell) method

 Installation

Benchtop, 19-inch panelBenchtop, 19-inch panelBenchtop, 19-inch panel

 Measurement range

 0-1 vol%, 0-100 vol%,

 99-100 vol% etc.

0-5 vol%, 0-100 vol%,

 98-100 vol% etc.

 0-10 vol%, 0-100 vol%,

 98-100 vol% etc.

Repeatability*1

±0.005 vol%/Measured value

  (99-100 vol% analyzer)

±0.05 vol%/Measured value

  (98-100 vol% analyzer)

±0.01 vol%/Measured value

  (98-100 vol% analyzer)

Response time30 sec or less (T90)
 (Can be changed from setting)
30 sec or less (T90)
 (Can be changed from setting)
30 sec or less (T90)
 (Can be changed from setting)

Sample gas flow rate

0.5 L/min0.5 L/min0.5 L/min

Sample gas pressure

49 kPa49 kPa49 kPa

Carrier gas flow rate

Approx. 12 mL/minApprox. 12 mL/min-

 Carrier gas pressure

49-100 kPa49-100 kPa-

Sample gas inlet, outlet, joint

Rc 1/8

 (Can be changed according to specifications)

Rc 1/8

 (Can be changed according to specifications)

Rc 1/8

 (Can be changed according to specifications)

Analog output

Maximum 8 ch,

 0-16 mA/ 0-20 mA/ 4-20 mA or
 0-1 V isolated

Maximum 8 ch,

 0-16 mA/ 0-20 mA/ 4-20 mA or
 0-1 V isolated

Maximum 8 ch,

 0-16 mA/ 0-20 mA/ 4-20 mA or
 0-1 V isolated

Relay contact16 ch isolated16 ch isolated16 ch isolated
CommunicationEthernetTM(Modbus®/TCP)EthernetTM(Modbus®/TCP)EthernetTM(Modbus®/TCP)
Power

100-240 V AC (±10%),

50/60 Hz (±1.0%)

100-240 V AC (±10%),

 50/60 Hz (±1.0%)

100-240 V AC (±10%),

 50/60 Hz (±1.0%)

Exterior dimensions430 (W) × 380 (D) × 132 (H) mm430 (W) × 380 (D) × 132 (H) mm430 (W) × 380 (D) × 132 (H) mm
MassApprox. 12 kgApprox. 12 kgApprox. 9 kg
OptionAuto-calibration functionAuto-calibration functionAuto-calibration function
Carrier gasO2 gas
 (Purity > 99.99 vol% O2)
O2 gas
 (Purity > 99.99 vol% O2)
-

*1: Based on factory inspection data
Modbus is a registered trademark of Schneider Electric USA Inc

相關手冊

相關產品

VA-5000 / VA-5000WM Series
VA-5000 / VA-5000WM Series

多組氣體分析儀

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