Method for detecting external oxygen barrier performance of medical plastic ampoules

Abstract: Drugs contain some oxidative components, so medical packaging should have high oxygen barrier properties. In this paper, Labthink OX2/230 oxygen transmission rate test system is used to test the oxygen barrier performance of medical plastic ampoules. The basic process of the test and the applicable scope and equipment parameters of the test equipment are introduced. Test equipment and test methods can be referred to.

Keywords: pharmaceutical packaging, pharmaceuticals, plastic ampoules, oxygen barrier, oxygen transmission rate, oxygen transmission rate test system

1, meaning

Ampoules are small containers for injectable liquids or oral liquids. The capacity is generally 1 ~ 25 mL. However, because glass ampoules are difficult for consumers to open and prone to accidents, many pharmaceutical industries use plastic ampoule. Not only easy to use but also easy to open.

If the plastic ampoules have low oxygen barrier properties, that is, the oxygen permeation amount is high, some components of the drug are easily oxidized under the action of oxygen, resulting in discoloration of the drug and reduction in efficacy. Therefore, the oxygen barrier property of plastic ampoules is one of the key performance indicators that pharmaceutical manufacturers should consider when selecting pharmaceutical packaging materials. Pharmaceutical manufacturers should strengthen the monitoring of oxygen transmission rate of plastic ampoules.

Figure 1 Medical plastic ampoules

2, the implementation of standards

The domestic test method for the oxygen permeability of packaging containers is the coulomb test method, GB/T 31354-2014 "Package and container oxygen permeability test method coulomb test method" This standard was implemented in 2015, stipulated in Oxygen transmission test for oxygen permeability of packages and containers by coulometric method under steady-state conditions and packaging materials for plastics and composite packages and containers suitable for use in dry environments with a volume of 2 L or less Sex test.

3, test samples

Plastic ampoules provided by a company.

4, test equipment

Jinan Languang Electromechanical Technology Co., Ltd. independently developed and designed the OX2/230 oxygen transmission rate test system.

Figure 2 OX2/230 oxygen transmission rate test system

4.1 Test principle

OX2/230 adopts the isobaric test principle (ie, the coulomb test method), clamping the pre-treated sample between the test chambers, oxygen or air flowing on one side of the film, and high-purity nitrogen in the film. Flowing on one side. Oxygen molecules diffuse through the membrane to the high purity nitrogen in the other side and are carried to the sensor by the flowing nitrogen. By analyzing the oxygen concentration measured by the sensor, parameters such as oxygen transmission rate are calculated. For packaging containers, high purity nitrogen flows within the container, and air or high purity oxygen surrounds the outside of the container.

4.2 Scope of application

(1) This equipment is suitable for oxygen transmission rate testing of containers, plastic film, sheet, paper, cardboard and composite materials.

Containers include oxygen transmission rate tests for bottles, bags, cans, boxes, and barrels made of plastic, rubber, paper, paper-plastic composite, glass, metal, etc., such as Coke bottles, peanut oil barrels, Tetra Pak, Vacuum packaging bags, metal three-piece cans, plastic cosmetic packaging, toothpaste hoses, jelly cups, yogurt cups, etc.

The film materials include oxygen transmission rate tests of film materials such as various plastic films, plastic composite films, paper-plastic composite films, co-extruded films, aluminized films, aluminum foils, and aluminum foil composite films.

The sheet material includes oxygen transmission rate tests of various sheet materials such as engineering plastics, rubber, and building materials, such as PP sheets, PVC sheets, and PVDC sheets.

In addition, the special configuration fixture of this equipment can also be applied to oxygen transmission rate test of special packaging such as medical packaging, automobile fuel tank, battery plastic casing, plastic pipe and solar backing.

(2) This equipment can meet a number of national and international standards, such as GB/T 31354, ISO 15105-2, GB/T 19789, ASTM D3985, ASTM F2622, ASTM F1307, ASTM F1927, JIS K7126-2, YBB 00082003.

4.3 Equipment parameters

Test range: film test 0.01 ~ 6500 cm3 / (m2 · d), container test 0.0001 ~ 60 cm3 / pkg · d.

Number of samples: Three identical or different samples can be tested simultaneously.

Resolution: Film 0.001 g/m2·24h, container 0.00001 g/pkg·d.

Test temperature range: 15 ° C ~ 55 ° C, temperature control accuracy ± 0.1 ° C.

Test humidity range: 0% RH, 35% RH ~ 90% RH, temperature control accuracy ± 1% RH.

Test gas: O2, air (air source user-supplied).

The system can support up to 10 instruments in parallel connection, and establish an efficient system for simultaneous testing of 30 samples.

It can be combined with the water vapor transmission rate test system to form a hybrid test system, which is controlled by a computer to achieve an efficient and convenient test method for simultaneous oxygen and water vapor transmission rate testing.

Support LystemTM laboratory data sharing system to manage test results and test reports.

5, the test process

(1) Fix the pinhole in the middle of the plastic tube to the special device of the test container by using fast-acting glue. After the sealing is completed, connect it to the instrument, and then seal the sample and special device with a sealed bag.

(2) Set the sample name, test temperature, test humidity and other parameters.

(3) Click the "Start Test" option.

(4) Start the air supply, adjust the humidity and the carrier gas flow.

(5) After the test is over, the instrument automatically calculates and displays the test results.

6, test results

The plastic ampoules tested in this paper have an oxygen transmission rate of 0.1825 cm3/pkg·d.

7. Conclusion

The barrier properties of plastic ampoules are important factors affecting the composition and color of the drug, especially the barrier to external oxygen. The higher the barrier property, the smaller the oxygen transmission rate, the longer the shelf life of the drug. The OX2/230 Oxygen Transmission Rate Test System is an oxygen transmission rate tester for thin film testing and container testing. It has simple operation, high test accuracy and high repeatability. Labthink has been committed to providing professional equipment and testing services to customers around the world, providing customers with a large number of packaging material performance data references. For details, you can log in to view. Labthink is looking forward to technical exchanges and cooperation with users in various industries.

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