Summary: Pharmaceutical plastic bottles, with their advantages of light weight, high strength, tightness, and good pressure resistance, are gradually replacing pharmaceutical glass bottles and are widely used in the field of oral solid drug and liquid drug packaging. However, due to the complex composition of drugs, various properties, and harsh storage conditions, the requirements for plastic bottles are also more stringent. The introduction of the corresponding standards means that companies need to strictly implement quality monitoring and inspection of medical plastic bottles. This article will briefly introduce the barrier properties and sealability test methods of pharmaceutical plastic bottles according to the standard requirements. Keywords: pharmaceutical plastic bottles, sealing, torsion, water vapor penetration Author: Labthink Technology Co., Ltd. background: The quality and safety of drugs directly affect national health. Packaging, as an important part of drugs, plays an important role in quality protection after production. Pharmaceutical plastic bottles, with their advantages of light weight, high strength, tightness and good pressure resistance, are gradually replacing pharmaceutical glass bottles and are widely used in the field of oral solid drug and liquid drug packaging. However, due to the complex composition of drugs, various properties, and harsh storage conditions, the requirements for plastic bottles are also more stringent. The production of medicinal plastic bottles must be subject to relevant inspections by the quality department to ensure that the produced pharmaceutical plastic bottles meet the country's factory specifications. During the use of medicine, it is ensured that no quality accidents will occur and the safety of drugs will be ensured. In 2002 , the State Drug Administration of China released the national pharmaceutical packaging container standard for oral liquid pharmaceutical plastic bottles, namely YBB00082002 Oral Liquid Pharmaceutical Polypropylene Bottle - Trial Version, YBB00092002 Oral Liquid Pharmaceutical High Density Polyethylene Bottle - Trial Version, YBB00112002 Oral Solid Pharmaceutical Polypropylene Bottle, etc. The introduction of these standards means that companies need to strictly implement quality control and inspection of medical plastic bottles. Pharmaceutical plastic bottles currently use PP , HDPE , PET three kinds of materials, this article will be based on the standard requirements of the above-mentioned materials for medical plastic bottles, briefly introduce the barrier properties and sealability test methods of medicinal plastic bottles. Barrier performance testing Barrier performance refers to the barrier effect of packaging materials on gases, liquids, and other permeants. Test items include gas and water vapor transmission performance testing two types. Oxygen and water vapor are important factors affecting drug quality. If the barrier properties of medicinal plastic bottles are not good, they will inevitably lead to deterioration of the drug due to excessive exposure to oxygen and water vapor. This requires the use of pharmaceutical plastic bottles. Barrier properties are tested. (1) Oxygen permeability detection Production of Labthink development density Bo PERME OX2 / 230 oxygen transmission rate test system, the test principle using pressure method and the like, through the container attachments included with the test, the detection of drugs can help businesses plastic bottle oxygen transmission rate indicator. The pre-treated blister sample is placed in the test chamber. Oxygen flows on the outside of the medicinal plastic bottle. High-purity nitrogen flows inside the plastic bottle. Oxygen molecules pass through the film by the plastic bottle due to the oxygen concentration gradient. The outer side diffuses into the inner high-purity nitrogen gas and is carried by the flowing nitrogen gas to the sensor. By analyzing the oxygen concentration measured by the sensor, the oxygen permeability and other parameters are calculated to evaluate the oxygen barrier performance of the test sample. . OX2/230 equipment comes with a constant temperature and humidity control function, the entire test process computer control, automatic testing, the user only need to clamp the sample, click on the test to fully automatic test, the end of the test automatically determine and issue a test report. (2) Water Vapor Infiltration Testing Water vapor permeability can be detected using PERME Bo adhesion W3 / 330 water vapor transmission rate test system is completed. The device uses the principle of electrolytic sensor test method, that is to say, the pre-treated medicinal plastic bottle is placed in the test chamber, nitrogen of a certain humidity flows on the outside of the plastic bottle, high-purity nitrogen flows inside the plastic bottle due to the presence of the moisture gradient. The water vapor molecules pass through the membrane and diffuse into the high-purity nitrogen gas from the outside of the plastic bottle and are carried by the flowing nitrogen gas to the sensor. The water vapor concentration measured by the sensor is analyzed to calculate the water vapor transmission rate and other parameters. , Evaluation of water vapour permeability of test pharmaceutical plastic bottles. Sealing test Sealing performance refers to the reliability of medical plastic bottle sealing, which can ensure the integrity of the entire product packaging seal. In order to ensure that the medicine is free from moisture and deterioration during the validity period, medicinal plastic bottles should have good sealing properties, and relevant national standards have made explicit provisions for this. Test method: Take a certain number of medicinal plastic bottles. Fill the bottles with appropriate amount of glass beads. Use NJY-20 torque meter or dynamometer wrench to tighten the bottle caps. Refer to the following table for specific bottle cap torque values: Cover diameter ( mm ) Torque ( N·cm ) 15~22 59~78 23~48 98~118 49~70 147~176 Then, the medicinal plastic bottle was placed in a container with a suction device. The device was immersed in water and evacuated to a vacuum of 27 kPa . The bottle was kept for 2 minutes without any water or air bubbles. Labthink 's MFY-01 Sealing Tester is vacuum-tested under negative pressure. Only the corresponding pressure value and time can be input during the experiment. The instrument can be fully automated and easy to operate. By vacuuming the vacuum chamber, the sample immersed in water generates a pressure difference between the inside and outside, visually observe the gas escape condition in the sample to determine the sealing performance of the sample, observe the expansion of the sample and release the vacuum after the recovery of the shape of the sample In order to determine the overall sealing performance of the package. In summary, through the above tests, companies can monitor the barrier properties and sealing performance of medical plastic bottles; in addition, the appearance and microbiological indicators of plastic bottles need to be monitored and controlled. Through comprehensive quality monitoring, the production process is adjusted to ensure the quality of the product, thereby avoiding product quality problems caused by the quality of the packaging. Copyright Notice: This article is copyrighted by Jinan Languang Electromechanical Technology Co., Ltd.