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What are the differences between domestic and foreign standards for medicinal eye drop bottles

Feb 19 , 2021

Pharmaceutical packaging is a powerful guarantee to ensure the quality of medicines and maintain their efficacy, and is an indispensable part of the circulation of medicines. As a container that directly contacts drugs, drug packaging requires industry standards to regulate its production quality, and eye drop bottles are no exception. Eye drops are a high-risk route of drug administration, and their packaging requirements are more stringent. So what are the differences between domestic and foreign standards for eye drop bottles?

What are the differences between domestic and foreign standards for medicinal eye drop bottles

eye dropper bottle

At present, the standards implemented for low-density polyethylene medical eye drops bottles are the national drug packaging (container) material standards promulgated by the State Food and Drug Administration, YBB00062000 and the 2015 version of the national drug packaging material standard YBB0062002-2015. This standard is only applicable For multi-dose eye drop bottles, the standard for single-dose eye drop bottles is mostly corporate standards. In the domestic standard, the appearance, tightness, dripping volume, dissolution test, clarity, clarity, easy oxidation, PH value change, heavy metals, non-volatile matter, ignition residue, and decolorization test of eye drop bottles , Microbial limits, etc. have specific requirements.

Although the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) do not directly stipulate the quality standards of eye drop bottles, there are relevant regulations for polyethylene plastic packaging materials in the general rules. Compared with China's eye drop bottle standards, the United States and European Pharmacopoeia have no special requirements on the amount of eye drop bottle dripping, pH change, and eye irritation test. However, there are no special requirements for aluminum, chromium, titanium, vanadium, zinc, and zirconium. The content has standard requirements, and other items are not much different.

Through the comparison of the quality standards of eye drop bottles at home and abroad, it is not difficult to see that the domestic packaging standards are already very standardized and can fully meet the packaging needs of the domestic pharmaceutical industry. Among them, there are many pharmaceutical packaging materials companies that are going to the international stage. It is believed that with the continuous innovation and improvement of my country's packaging processing technology, the domestic pharmaceutical packaging standards will be in line with international standards and help the internationalization of Chinese pharmaceutical companies' brands.


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