The ISO 8362-4 standard, developed by the International Standards Organization (ISO), describes the properties and test methods of injection bottles made of molded glass, which are among the injection containers and accessories. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 8362-4 Injection containers and accessories - Part 4: Injection bottles made of molded glass.
This standard describes the shape, dimensions and capacities of glass bottles used for injectable preparations. In addition, the performance requirements of the materials and containers from which such containers are produced are also included in this standard.
The ISO 8362-4 standard covers colorless glass containers molded from borosilicate or soda lime glass, with or without inner surface treatment. The requirements for packaging, storing or transporting injection products are described in this standard.
Containers made of molded glass are considered suitable for the packaging and storage of injectable preparations until they are applied for medical purposes. These containers may be made of different types of glass that affect their chemical resistance properties. For example, containers made of borosilicate glass have a very high chemical resistance. In contrast, containers made of soda, lime, and silica glass have a lower chemical resistance. The main thing here is what purpose the containers will be used for.
Since the containers are made from different types of glass and filled with injectable preparations, the chemical behavior of the inner surface is crucial. Test methods capable of measuring this performance are necessary. The test methods described in the ISO 8362-4 standard allow for the measurement of this performance based on hydrolytic resistance, and the measurement results make it possible to classify the containers into the correct categories.
Within the scope of laboratory services, our organization also provides testing services for injection bottles made of molded glass, which are among ISO 8362-4 injection containers and accessories.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
