Quality standard for low-density polyethylene ophthalmic for eye droppers

With the continuous advancement of medical technology and people's increasing attention to drug safety, the quality standards of drug packaging materials are particularly important. As a packaging container for drugs that directly contact the eyes, the quality standards and test items of low-density polyethylene (LDPE) medicinal eye drop bottles are directly related to the safety and effectiveness of drugs. This article will focus on the quality standards of "YBB00062002-2015 Low-density polyethylene medicinal Ophthalmic for Eye Droppers" and introduce its test items and specific requirements in detail.

5ml eye dropper bottle

1. Appearance inspection

Appearance inspection is the first step in evaluating the quality of Ophthalmic for Eye Droppers. In bright natural light, through direct visual inspection, the eye drop bottle should be uniform in thickness, smooth in surface, consistent in color, without convex and concave points, and the inner wall of the bottle should be smooth and free of easy-to-fall objects. The threads of the bottle mouth and bottle cap should be clear and smooth to ensure the convenience and sealing of use.

2. Identification test

Identification test is mainly used to confirm the material of the Ophthalmic for Eye Droppers. Infrared spectroscopy is one of the main means of identifying drug packaging materials. By applying the sample to a slightly heated potassium bromide wafer and measuring it according to the spectrophotometric method, the resulting spectrum should be basically consistent with the control spectrum. In addition, density detection is also an important item for identification. The density of LDPE should be in the range of 0.910~0.935 g/cm³. This physical property constant has a certain identification effect on the purity and formula of the material.

3. Microbial limit detection

Microbial limit detection is a key step to ensure that the Ophthalmic for Eye Droppers is free of microbial contamination. According to the relevant standards of "YBB20072012 Low-density Polyethylene Medicinal Eye Drop Bottle", take several test bottles, add 1/2 nominal capacity of sodium chloride injection, tighten the cap, shake for 1 minute, and then perform membrane filtration detection. The number of bacteria in each bottle shall not exceed 100 cfu, molds and yeasts shall not be detected, and Staphylococcus aureus and Pseudomonas aeruginosa shall not be detected. Whether the microbial limit meets the standard is directly related to the quality of the eye drop bottle. Unqualified products will contaminate the drugs and affect the health of patients.

4. Sealing test

Sealing test is an important item to ensure that the Ophthalmic for Eye Dropper does not leak during use. The test is divided into two steps: first, under the condition of torque 55~80 N·cm, the bottle mouth and bottle cap should fit properly and no slipping should occur; second, place the test bottle with the bottle cap screwed tightly in a container with a vacuum device, add a baffle, immerse it in water, and evacuate to a vacuum degree of 20 KPa for 2 minutes. There should be no water ingress or bubbling in the bottle.

eye drop bottles

5. Drip volume test

Drip volume test is used to evaluate the performance of eye drop bottles in actual use. Take several test bottles, fill them with the marked capacity of sodium chloride injection, wipe the bottle mouth, discard the first 10 drops first, and then collect 50 drops evenly. The average drip volume should be 0.05±0.01 ml. This test item ensures the accuracy and consistency of drug use.

6. Dissolution and non-volatile matter detection

Dissolution and non-volatile matter detection are important indicators for evaluating the safety of eye drop bottles. Take the flat part of the test bottle with an inner surface area of 600 cm², cut it into small pieces and place it in a conical bottle. After oscillation washing, drying and heat preservation, measure the clarity, pH change, oxidizable substances, heavy metals, ultraviolet absorbance, etc. of the solution. In addition, the non-volatile matter test requires the precise measurement of 50 ml of the test solution and blank solution, drying to constant weight at 105°C, and the difference between the test solution residue and the blank solution residue shall not exceed 5.0 mg.

VII. Other test items

In addition to the above main test items, it also includes ignition residue test, n-hexane non-volatile matter test, decolorization test, sterility test and biological test. These test items ensure the material safety, chemical stability and biocompatibility of the eye drop bottle from multiple angles.

The quality standards of low-density polyethylene medicinal Ophthalmic for Eye Droppers cover multiple test items from appearance to material identification, microbial limit, sealing, dripping volume, dissolution and non-volatile matter. These testing items ensure the safety and effectiveness of eye drop bottles during production, use and storage, safeguarding drug safety.