Quality Control in Medical Oxygen Gas Production and Verification

Regulation of Medical Gases

Medical gases are regulated by the United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) that sets standards for all medical gases including those that address quality, strength, purity, packaging, labeling, and identification. HORIBA contributes in this field by providing a wide range of analysis and measurement solutions with high accuracy.

European Pharmacopoeia Standard

The medical gases used in a hospital are life-supporting element that gives direct influence on maintaining the life of patients. Therefore, at the sections where the medical gases are used, the medical gas must be clean and highly pure. For the European Pharmacopoeia, the analytical methods and the concentration are strictly addressed in the guideline. 

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

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

Oxygen Production Process in Air Separation Plant

Medical oxygen is usually produced by the air separation plant. Air separation plant separates atmospheric air into its primary components oxygen (O2), nitrogen (N2), and argon (Ar) by distillation at cryogenic temperatures. Separation of air is performed in the distillation unit using the difference in the boiling points of each constituent gas. Produced in ASU medical gas is distributed to its users in gas cylinder truck. Quality assurance process is conducted before distribution to ensure, if the oxygen product meets the required standard and its expectations.

Figure 2: Air Separation Plant

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

Specifications of Medical Oxygen Gas Analyzer

 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

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VA-5000

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