Key points for testing of oral solid pharmaceutical polypropylene and polyethylene

 

　　Polypropylene is a kind of thermoplastic resin made by polymerization of propylene, usually translucent colorless solid, odorless and non-toxic. Due to the regular structure and high crystallization, the melting point can be as high as 167°C. Heat and corrosion resistant. Its outstanding advantage is that its oral liquid medicinal polypropylene bottle products can be steam sterilized. The packaging material has a low density and is the lightest general-purpose plastic. The disadvantage is poor low-temperature impact resistance and easy aging.

 

High-density polyethylene (HDPE) products have good abrasion resistance, electrical insulation, toughness and cold resistance; good chemical stability, insoluble in any organic solvents at room temperature, acid, alkali and various salts Corrosion; After being made into oral liquid medicinal high-density polyethylene bottles, the permeability to water vapor and air is low, and the water absorption is low; however, it has poor aging resistance and environmental stress cracking resistance, especially thermal oxidation. It will reduce its performance, so antioxidants and ultraviolet absorbers must be added to the resin to improve this deficiency. In the production process, the use of additives and the characteristics of the material itself may form non-volatiles and migrate to the medicine, thereby affecting the safety of the medicine.

 

"Polyethylene terephthalate" refers to the polyester material in the oral solid pharmaceutical polyester bottle, and the abbreviation PET is a polymer compound. Polyethylene terephthalate (PET) is produced by polycondensation of terephthalic acid (PTA) and ethylene glycol (EG). It is widely used in the packaging industry, electronic appliances, medical and health, construction, automobiles and other fields. Among them, packaging is the largest non-fiber application market for polyester, and it is also the fastest growing field for PET. PET has good fiber-forming properties, mechanical properties, abrasion resistance, creep resistance, low water absorption and electrical insulation properties. The advantages of oral liquid medicinal polyester bottles are light weight (only 1/9～1/15 of the weight of the glass bottle), high mechanical strength, not easy to break, easy to carry and use, good transparency, shiny surface, non-toxic, Good air tightness, good freshness, low energy consumption for producing polyester bottles, and used bottles can be recycled. However, a certain proportion of additives such as lubricants, inorganic powders, coupling agents, etc. need to be added in the production process. Moreover, the temperature has a greater impact on the finished product. If the temperature is not well controlled during the production process, the mechanical strength of the product is likely to be insufficient. Therefore, the performance testing of its finished products is a necessary condition to determine whether the quality is qualified.

 

　　 1. Tightness test and test method

 

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

 

Labthink Jinan Languang Electromechanical Technology Co., Ltd. MFY-01 sealing tester, the sealing tester can also be called sealing performance tester, sealing degree tester, etc., suitable for food, medicine, medical equipment, daily chemicals, automobiles, electronic components , Stationery, pesticides, veterinary drugs and other industries of packaging bags, bottles, tubes, cans, boxes, etc. leakage and sealing performance test. It can also be used for leak detection of pharmaceutical aluminum-plastic blister and sealing performance test of packaging parts after drop and pressure test.

 

　　 Test process: Take several samples to be tested and place them on the NJY-20 torque meter. Under the torque indicated in Table 1 below, the bottle mouth and the bottle cap should match properly without slipping teeth.

 

After 　　 open the bottle, put an appropriate amount of glass beads into the sample bottle, and lock the bottle cap according to the torque indicated in Table 1 below. Place the locked sample in the vacuum tank of the MFY-01 sealing tester, and set the experimental parameters by evacuating the vacuum chamber to make the vacuum degree reach 27kPa, so that the sample immersed in water will generate internal and external pressure difference to maintain 2 minutes. According to the standard YBB00122002-2015\YBB00112002-2015\YBB00262002-2015, there should be no water ingress or bubbling in the bottle.

 

　　

 

Key points for testing of oral solid pharmaceutical polypropylene and polyethylene

　　 2. Non-volatile matter detection

 

"Non-volatile matter" refers to the part where the liquid or solid in a substance cannot evaporate or sublime into a gas under certain circumstances. The non-volatile matter in the packaging will migrate into the medicine and affect the quality and use effect of the medicine. Therefore, the determination of non-volatile matter is very important to control the quality of oral solid pharmaceutical bottles.

 

　　Testing instrument: Labthink Jinan Languang Electromechanical Technology Co., Ltd. is a new generation of fully automatic high-efficiency C830 migration and non-volatile matter tester, which can be widely used in the non-volatile matter determination of various pharmaceutical packaging materials. The equipment complies with the GMP standards of the pharmaceutical industry and the determination requirements of "non-volatile substances" in the latest medicine package-plastic medicine packaging material standard of the 2015 edition.

 

　　 Test process: The test solution is prepared, and the flat part has an inner surface area of ​​600 cm2 (divided into small pieces of 5 cm in length and 0.3 cm in width) in three parts, placed in conical flasks with stoppers, added appropriate amount of water, shaken and washed, and discarded. Repeat this operation twice. After drying at 30℃-40℃, soak in 200ml of water (70℃±2℃), 65% ethanol (70℃±2℃) and n-hexane (58℃±2℃) for 24 hours, take it out and let it cool to room temperature , Use the same batch of test solvent to replenish the original volume as the test solution. Use the same batch of water, 65% ethanol, and n-hexane as the blank solution for the experiment.

 

　　Accurately measure 50.0ml each of water, 65% ethanol, n-hexane test solution and blank solution, respectively, and place them in the instrument. Set the experimental temperature of the C830 migration and nonvolatile matter tester to 105°C for drying until constant weight. According to the standard YBB00122002-2015\YBB00112002-2015\YBB00262002-2015, the difference between the water non-volatile residue and the blank residue shall not exceed 12.0mg; the difference between the 65% ethanol non-volatile residue and the blank residue shall not exceed 50.0mg; n-hexane does not The difference between the volatile residue and the blank residue shall not exceed 75.0mg.

 

　　 3. Detection and detection method of water vapor transmission

 

　　The main function of medicine packaging is to protect the safety of medicines during storage and transportation. The water vapor transmission rate is an important indicator to measure whether the quality is qualified. The water vapor transmission rate is large, and long-term storage and transportation will cause the medicine to become damp, which affects the safety of medicine.

 

Test instrument: Labthink Jinan Languang Electromechanical Technology Co., Ltd. W3/030 water vapor transmission rate tester, based on the cup method test principle, is a professional water vapor transmission rate tester for thin film samples, suitable for plastics Measurement of water vapor transmission rate of films, sheet materials and medical materials such as films and composite films. Through the measurement of water vapor transmission rate, the technical indicators of controlling and adjusting materials can be achieved to meet the different needs of product applications. This equipment meets a number of national and international standards: ISO 2528, GB 1037, GB/T 16928, ASTM E96, ASTM D1653, TAPPI T464, DIN 53122-1, JIS Z0208, YBB 00092003.

 

  Testing process:

 

(1) The container test is carried out in accordance with the third method of standard YBB 00092003-2015. Add purified water with the indicated capacity to the sample and place it in a constant temperature and humidity box. The temperature accuracy is ±0.6℃ and the experimental temperature is set to 25℃. ±2℃; Set the relative humidity to 95%±5%, the humidity accuracy of the constant temperature and humidity box is ±2%, and leave it for 24 hours. According to the standard YBB00122002-2015\YBB00112002-2015\YBB00262002-2015, each sample shall not exceed 100mg/24h·L.

 

(2) For sheet test, take a Φ74 mm sample to be tested and place it in the W3/030 water vapor transmission rate tester moisture permeability cup and clamp it, and place the moisture permeability cup in W3/030 water vapor transmission rate test Inside the instrument. Set the experiment, the temperature is 20℃±5℃; the relative humidity is 65%±5%, and the blowing wind speed is 0.5-2.5m/s. When both sides of the sample reach the penetration balance, the system will automatically stop and record the test results to see if it meets the production quality control standards of the enterprise or the quality standards of the purchasing enterprise.

 

　　Labthink Labthink is committed to helping customers deal with new packaging problems through the improvement of packaging testing technology and the development of cutting-edge testing instruments, and to help the quality and safety of packaging related industries. For more information, please follow the Labthink WeChat public account "Jinan Languang Packaging Safety Testing Expert".