Detection points of polypropylene pharmaceutical eye drops bottle

Polypropylene (PP) is a semi-crystalline thermoplastic resin obtained by polymerizing propylene. It has high impact resistance, strong mechanical properties, resistance to various organic solvents and acid-base corrosion. It has a wide range of applications in the industry and is one of the common polymer materials. It is non-toxic, tasteless, low in density, and has better strength, rigidity, hardness and heat resistance than low-pressure polyethylene, and can be used at about 100 degrees. However, due to the presence of a side branch of a methyl group, polypropylene is more susceptible to oxidative degradation under the action of ultraviolet light and heat. Moreover, it becomes brittle at low temperature, is not wear-resistant, and is easily deteriorated. In view of its performance characteristics, the polypropylene eye drop bottle is a plastic packaging container that directly contacts the drug. The quality of polypropylene eye drops directly affects the safety of the drug. Therefore, the detection of related quality control is especially necessary and critical.

Eye drops are in direct contact with the eye and are a high-risk route of administration. Due to the particularity of the site of administration, the safety and controllability of the quality is particularly important. Because plastic packaging, under certain conditions, will transfer certain substances contained in the production process or itself to the content, which has the risk of causing it to react with the contents, thereby giving the package the effectiveness and safety of the drug. Come to a serious impact. Therefore, the detection of non-volatiles in polypropylene pharmaceutical eye drops bottles is very important.

The test data is used as a reference to determine if the package is suitable for packaging the drug. For example, in general, the lower the light transmittance, the better the barrier property to light, and the less light-degrading impurities are produced. If the eye drops contain photoreceptor components such as ofloxacin, the influence of the transmittance of the package material on the contents should also be considered when selecting the packaging materials. Quality control indicators for packaging materials are an important reference for measuring their performance, which is especially critical in pharmaceutical packaging materials.

First, the sealing test and test method

Test instrument: Labthink Jinan Languang Electromechanical Technology Co., Ltd. NJY-20 torque meter, which is a special equipment for testing the packaging products, nozzle packaging products, hose packaging products, bottle cap locking, opening torque value, its measurement accuracy High and stable.

Labthink Jinan Languang Electromechanical Technology Co., Ltd. MFY-01 seal tester, seal tester can also be called seal performance tester, seal degree tester, etc., suitable for food, medicine, medical equipment, daily chemical, automotive, electronic components , leaking sealing performance test of packaging bags, bottles, tubes, cans, boxes, etc. in stationery, pesticides, veterinary drugs, etc. It can also be used for leak detection of pharmaceutical aluminum-plastic blister and sealing performance test after the package has been dropped and withstand voltage test.

Test procedure: Take a few samples of polypropylene medicinal eye drops bottle and place it on NJY-20 torque meter. Under the condition of measuring torque of 55-80N·cm, the bottle mouth and bottle cap should be matched properly and should not be slippery. tooth.

Then open the bottle and lock the cap with a force of 55-80 N·cm. The locked sample is placed in the vacuum tank of the MFY-01 sealing tester. By vacuuming the vacuum chamber, the experimental parameters are set so that the vacuum degree reaches 20 kPa, so that the sample immersed in water generates internal and external pressure difference and maintains 2 minutes. According to the standard YBB00072002-2015, there must be no water or bubbling in the bottle.

Second, non-volatiles detection

Non-volatile matter refers to the part of a liquid or solid in a substance that cannot be evaporated or sublimated into a gas discharge under certain circumstances. The non-volatiles in the package will migrate to the drug and affect the quality and effectiveness of the drug. Therefore, the determination of non-volatiles is critical to controlling the quality of polypropylene eye drops.

Test equipment: Labthink Jinan Languang Electromechanical Technology Co., Ltd. A new generation of fully automatic high-efficiency C830 migration and non-volatiles analyzer, can be widely used in the determination of non-volatiles of various pharmaceutical packaging materials. The equipment meets the requirements of the GMP standards of the pharmaceutical industry and the “non-volatile substances” in the new version of the zui new drug pack-plastics package.

Test procedure: Prepare the test solution, take a flat surface area of ​​600cm2, cut into small pieces of 3cm*0.3cm, place 500ml in a conical flask, add 150ml of water, shake and wash, discard the water. After drying at 30 ° C to 40 ° C, 200 ml of water for injection was added, and the mixture was stoppered, kept at 70 ° C ± 2 ° C for 24 hours, taken out, and allowed to cool to room temperature to obtain a test solution. The experiment was carried out using the same batch of water as a blank liquid.

50.0 ml of each test solution and blank solution were accurately weighed and placed in the instrument, and the C830 migration amount and the non-volatile matter tester were set to 105 ° C for drying until constant weight. According to the standard YBB00072002-2015, the difference between the test solution and the blank solution of the polypropylene drug eye drop bottle should not exceed 5.0 mg.

Labthink is committed to helping customers cope with new packaging problems and improving the quality and safety of packaging-related industries through the development of packaging inspection technology and the development of sophisticated inspection instruments. For more information, please pay attention to Labthink Languang public number "Jinan Languang packaging safety testing experts."