Summary:
Some components in the liquid are sensitive to oxygen and are easily oxidized, which affects the efficacy. This paper takes the three-layer co-extruded infusion bag as an example, and uses the self-developed by Jinan Languang Electromechanical Technology Co., Ltd.
VAC-V2
The differential pressure method gas permeation tester tests the oxygen permeation amount, and briefly introduces the test principle and equipment parameters of the equipment, describes the basic process of the test, and provides the enterprise with the solution to how to control the oxygen barrier of the pharmaceutical soft plastic packaging. reference.
Key words:
Oxygen barrier, oxygen transmission, infusion bag, medical packaging, oxygen transmission rate tester, oxidation
1
,significance
Infusion is a common treatment method for diseases. In the process of storing the injection, if it is stored improperly, the liquid discoloration and precipitation will occur. These phenomena appear and some components in the liquid are easily oxidized. Big relationship. Some ingredients in the liquid are sensitive to oxygen, such as vitamins
C
Metal ions, bromides, alcohols, aromatic amines, phenothiazines, etc., are prone to oxidation reaction when oxygen is encountered, resulting in changes in the color of the liquid, changes in active ingredients, and reduced efficacy. Therefore, reducing the oxygen content in the infusion bag during packaging and selecting an infusion bag with higher oxygen barrier property is an effective way to prevent the oxidation of the drug solution and maintain the efficacy of the drug solution.
Figure
1
Infusion bags
2
Testing standard
At present, the reference standards for the oxygen permeation of pharmaceutical packaging mainly include
GB/T 1038-2000
Plastic film and sheet gas permeability test method
Pressure difference method,
YBB00082003
"Gas permeability measurement method". The reference standard for the oxygen permeation volume of the infusion bag is
YBB00082003
"Gas Permeability Measurement Method", which specifies two methods of equal pressure method and differential pressure method. The test is carried out by differential pressure method.
3
Test sample
A three-layer co-extruded infusion bag produced by a manufacturer.
4
Test equipment
This article uses
Labthink
Languang
VAC-V2
The differential pressure gas permeation meter measures the oxygen permeation of the infusion bag sample.
Figure
2 VAC-V2
Differential pressure gas permeation instrument
4.1
Test principle
This equipment is developed based on the differential pressure method. The test chamber of the device is divided into upper and lower parts. The upper chamber is a high pressure chamber and the lower chamber is a low pressure chamber. The sample is located between the two test chambers. During the test, the sample is clamped between the two test chambers. First, the low pressure chamber is evacuated, and then the whole system is evacuated. When the specified vacuum is reached, the low pressure chamber is closed and a certain pressure is applied to the high pressure chamber. Test gas to make two test chambers
(
That is, both sides of the sample
)
A constant pressure difference is formed, and the test gas will permeate from the high pressure chamber to the low pressure chamber under the action of the pressure difference, and the respective barrier coefficients of the sample are obtained by monitoring the pressure in the low pressure chamber.
4.2
Scope of application
(1)
This equipment is specially used for the test of gas permeability, permeability coefficient, solubility coefficient and diffusion coefficient of various film and sheet samples at various temperatures.
l
Film type: such as various plastic film, plastic composite film, paper-plastic composite film, co-extruded film, aluminized film, aluminum foil, aluminum foil composite film and other film-like materials.
l
Sheets: such as various engineering plastics, rubber, building materials and other sheet materials, such as
PP
Sheet,
PVC
Sheet,
PVDC
Sheet.
(2)
The equipment can also be extended to aerospace materials, paper and paperboard, paint film, fiberglass cloth, fiberglass paper, cosmetic hose sheets, various rubber sheets and other materials for gas permeability testing.
(3)
This equipment is suitable for the permeability test of various gases, such as oxygen, carbon dioxide, nitrogen, helium, air and so on.
(4)
This equipment meets a number of national and international standards, such as
ISO 15105-1
,
ISO 2556
,
GB/T 1038
,
ASTM D1434
,
JIS K7126-1
,
YBB00082003
.
4.3
Device parameters
l
The test range of the device is
0.05 ~ 50000 cm 3 /m 2 ·24h·0.1MPa
, vacuum resolution can be reached
0.1 Pa
.
l
The temperature control range of the device is
5
°C
~ 95
°C
, temperature control accuracy is
±0.1
°C
The humidity control range is
0%RH
,
2%RH ~ 98.5%RH
,
100% RH
, the humidity control accuracy is
±1% RH
It can meet the testing requirements under different test conditions of the sample.
l
The unit has three completely independent test chambers that can test three identical or different specimens simultaneously.
l
This equipment can be used to fit data at any temperature and easily obtain test results under extreme test conditions.
l
After the system is modified, the equipment can also support the testing of toxic gases and flammable and explosive gases.
l
This equipment provides a standard membrane for quick calibration to ensure the accuracy and versatility of the test data.
l
This device supports
Lystem TM
Laboratory data sharing system, unified management of test results and test reports.
5
,Experimental procedure
(1)
Use a cutter to cut the diameter from the surface of the infusion bag sample to
97 mm
Sample
3
sheet.
(2)
Along the device
3
Apply a layer of vacuum grease to the periphery of each sample chamber. Note that the vacuum grease does not contaminate the test area, and then the diameter is placed in the test area.
65 mm
Filter paper.
(3)
Separately
3
Tablet sample clamped to
3
On the test cavity.
Figure
3
Sample clamping process
(4)
Set the test temperature, humidity, sample thickness and other parameters information, open the vacuum pump, water bath temperature control device, click the start test option, the test begins.
(5)
The instrument automatically calculates the test results based on the monitoring of the low pressure chamber pressure.
6
,test results
In view of the high humidity of the infusion bag storage environment, the test conditions for its oxygen permeation amount are
twenty three
°C
,
50% RH
.
3
The test results of the oxygen permeation of the samples are respectively
855.465 cm 3 /m 2 ·24h·0.1MPa
,
861.379 cm 3 /m 2 ·24h·0.1MPa
,
859.619 cm 3 /m 2 ·24h·0.1MPa
.
7
,in conclusion
Oxygen permeation is an important performance indicator for infusion bags, and its value is critical to the quality of the package.
VAC-V2
The differential pressure gas permeation instrument has the advantages of accurate test results, high measurement accuracy, high degree of automation of the equipment in testing the oxygen permeation amount, and the device can also be used for testing the gas permeation amount of air, nitrogen, carbon dioxide and helium. wide range. In addition to the oxygen permeation, it is also necessary to check the water vapor permeation volume, puncture force, puncture retention and insertion point impermeability of the infusion bag. You can log in the relevant test equipment.
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advisory. Jinan Languang Electromechanical Technology Co., Ltd. is always committed to providing professional testing equipment and services to customers all over the world.
Labthink
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