What are the physical testing items for pharmaceutical glass bottles?

Pharmaceutical glass bottles are packaging materials that directly contact with medicines and store medicines for a long time, the quality of which is directly related to the health of the public and occupies a large proportion in the field of pharmaceutical packaging materials. Commonly used medicinal glass bottles in clinic are ampoules, cillin bottles, I.V., tablets, capsules, powder injection bottles, etc. The quality of medicinal glass bottles should be moisture-absorbent, insulated, and have good or poor insulation properties. Pharmaceutical glass bottles should have hygroscopicity, thermal insulation, heat resistance and cold resistance and other characteristics, to meet the requirements of pharmaceutical companies on chemical synthesis, biochemicals, phytochemicals and other raw materials such as drugs and a variety of pharmaceutical preparations or traditional Chinese medicine holding requirements. Therefore, it is very important to test the physical indexes of pharmaceutical glass bottles in the laboratory of pharmaceutical factories.

Pharmaceutical glass bottle inner surface water resistance:

As a pharmaceutical glass bottle has many advantages, but there is also a major drawback: under certain conditions there will be glass flakes from the inner surface of the glass container, directly into the solution, sometimes difficult to detect with the naked eye. Although no adverse events directly related to glass dislodgment have been reported, the presence of these glass flakes in IV medications may lead to the development of thrombosis and other vascular events (e.g., phlebitis); in the case of subcutaneous inoculations, dislodgment may lead to the development of foreign body granulomas, localized injection-site reactions, and increased immunogenicity. Therefore, the water resistance test equipment for the inner surface of pharmaceutical glass vials, mortar and pestle, is a commonly used glass vial testing instrument in the laboratory of pharmaceutical factories.

Experimental method of mortar and pestle:

According to the requirements of YBB00252003-2015 Determination and grading of water resistance of glass particles at 121℃ and YBB00362004-2015 Determination and grading of water resistance of glass particles at 98℃, 2g of glass particles with a particle size of 300-500μm should be immersed in the test water at 98℃ for 60 minutes. The degree of water erosion of glass particles is determined and graded by titrating the erosion solution.

Pharmaceutical glass bottle thermal shock resistance test:

Thermal shock resistance test is also a common testing equipment in the laboratory of pharmaceutical factories, because the bottles need to be filled after the completion of high-temperature sand bacteria, lyophilized powdered medicines in the production of low-temperature lyophilization, the glass bottle is a test. For pharmaceutical bottles according to the standard requirements of borosilicate glass 60 ℃, soda-lime glass 42 ℃, this new standard are the same as ISO. Glass bottle thermal shock tester RCY-02 test thermal shock resistance of pharmaceutical glass bottles experimental method: set the thermal shock tester high temperature tank and low temperature tank temperature, so that it reaches the pre-set temperature difference, the pharmaceutical glass bottle specimens in the high-temperature tank high-temperature heating, quickly placed in the low-temperature tank, remove the specimen to observe the sample breakage rate after the hot and cold shock.