Three standards for judging the quality of eye drop bottles

Eye drops are a relatively large category of ophthalmic drugs. The quality of the eye drops bottle is related to the stability of the drug within the validity period. Then, how to judge the quality of the pharmaceutical packaging, follow the following three standards:

eye dropper bottle

1. Biosafety inspection items:

Number of microorganisms: Measure the amount of various microorganisms according to what dosage form the material and container are used for. ...

Safety: According to the material and the type of the container used, it is necessary to select items such as abnormal toxicity, eye irritation, bacterial endotoxin and so on.

2. Performance inspection items

Chemical performance: First check the amount of material leached in various solvents, mainly checking harmful substances, low molecular weight substances, unreacted substances, substances brought in during production, additives, etc. Commonly used solvents are water, ethanol, and n-hexane. Usually the test items include reducing substances, heavy metals, residues on ignition, PH value, UV absorbance, etc. Then check the specific substances in the material, such as the amount of vinyl chloride monomer in the PVC hard sheet, the amount of polypropylene infusion bottle catalyst, and the residual amount of solvent in the composite material section. Finally, check the additives added during the processing of the eye drop bottle material, such as the sulfide in the rubber, the plasticizer in the polyvinyl chloride film (dioctyl phthalate), and the amount of antioxidant in the polypropylene infusion bottle . ...

Performance: The container needs to be checked for tightness, water vapor transmission, drop resistance, and dripping (if there is a quantitative function container); the sheet needs to be checked for water vapor transmission, tensile strength, and elongation; such as the material, The container needs to be used in combination, and the heat seal strength, torque, and size of the combined part should be checked.

3. Material identification project

Mainly to confirm the characteristics of the material, this is because special inspection items need to be set according to the different materials, such as polyvinyl chloride materials should be checked for oxyethylene monomer, polyethylene terephthalate (PET) materials should be checked for acetaldehyde residues the amount. The second is to prevent adulteration. In addition, the user must be able to confirm the consistency of the source of the eye drop bottle material.