What are the inspection items for eye drop bottles

As an important tool for eye medication, the quality of eye drop bottles is directly related to the user's vision health and safety. According to the standard YBB00062002-2015 "Low-density polyethylene eye drop bottles", the inspection items of eye drop bottles include the following:

eye drop bottles

Appearance and identification: The eye drop bottle must first have an intact appearance without obvious foreign matter or defects. At the same time, the uniqueness and identifiability of the product are ensured through labeling and packaging to avoid confusion.

Density and sealing: The density test of the eye drop bottle ensures that the bottle material meets the requirements, while the sealing test ensures that it does not leak during use to avoid contamination and waste of the liquid medicine.

Drip volume and visible foreign matter: The accurate control of the drip volume directly affects the dosage of the liquid medicine, while the detection of visible foreign matter eliminates any impurities that may affect the clarity and safety of the liquid medicine.

Dissolution test: Including the detection of clarity, pH change, oxidizable substances, heavy metals, absorbance and non-volatile substances to evaluate the stability and safety of the liquid medicine in the bottle.

Ignition residue and n-hexane non-volatile matter: Ensure the compliance of the residue after the bottle is burned under specific conditions, and exclude the possible contamination of the non-volatile matter on the liquid medicine.

Decolorization test and microbial limit: The decolorization test detects the effect of the bottle material on the photostability of the liquid medicine, and the microbial limit ensures the sterility of the bottle before and after use.

Biological test: Biological tests include abnormal toxicity and eye irritation tests. The abnormal toxicity test ensures that the bottle material will not have adverse reactions or toxic effects on the human body; the eye irritation test evaluates the irritation reaction that may be caused by the liquid medicine contacting the eyes.

Through the above series of strict testing items, the manufacturers and users of eye drop bottles can ensure the quality and safety of the products, thereby effectively ensuring the effect of eye drug administration and the health of users. These testing items not only meet the requirements of the standards, but also reflect the high requirements and challenges of pharmaceutical processes and technologies, providing reliable protection for eye health.