The importance of eye drop bottle tightness test

Eye drops are one of the commonly used pharmaceutical dosage forms for eye diseases. For many eye diseases, eye drops have a direct and rapid therapeutic effect. Because it acts directly on the eyes, eye drops have very strict requirements on the transparency, air tightness, and pressure resistance of the pharmaceutical packaging. Among them, the tightness test is an important test index for the eye drop bottle.

5ml eye dropper bottle

Tightness refers to the feature of packaging to prevent other substances from entering or the contents from escaping. In the production process of the eye drop bottle, due to the many production links, leaks, press-throughs, or cracks and pores in the material itself may occur, resulting in small holes or weak points of strength between the inside and the outside. If the sealing performance is not up to standard, external water vapor will enter the package and contact the medicine, and the medicine may be contaminated, invalid or deteriorated, which will endanger the health of the patient. Therefore, to ensure the efficacy of the drug within the validity period, a package with good sealing properties must be provided, and the sealing performance test has become one of the basic test items for many drug packages.

Eye drop bottles are generally made of plastic material that is easy to squeeze, and the common one is low-density polyethylene (LDPE). In the YBB20072012 "Low Density Polyethylene Medical Eye Drop Bottles" standard, specific requirements are made for the sealing test method:

(1) Take several test bottles. Under the condition of a torque of 55-80N·cm, both the mouth and the cap should match properly, and the teeth should not be slippery.

(2) Take several test bottles, open the bottles first, and then tighten the caps (the test bottles use a force measuring wrench to tighten the bottles and caps, the torque is 55-80N·cm), and place them in a container with a suction device Afterwards, add a baffle, immerse in water, vacuum to a vacuum of 20kPa, and maintain for 2 minutes. There should be no water or bubbling in the bottle.

There may be slight differences in national standards for the test methods for the tightness of eye drop bottles, but the purpose is to ensure the safety of the drugs and bring better treatment effects for patients. For the tightness test, the manufacturer of the drug packaging Pharmaceutical companies should pay enough attention.