| Oral solid pharmaceutical packaging is the packaging material containing oral solids, such as tablets and capsules. Due to its direct contact with drugs, the quality of packaging materials directly affects the quality and safety of drugs. Therefore, the quality inspection of pharmaceutical packaging for oral solid is very important and key.
Polypropylene is a thermoplastic resin made by polymerization of propylene. It is usually a translucent colorless solid, odorless and non-toxic. Due to the regular structure and high crystallization, the melting point can be as high as 167 ℃. Heat and corrosion resistance. Its outstanding advantage is that its oral liquid medicinal polypropylene bottle products can be disinfected by steam. The packing material has low density and is the lightest general plastic. The disadvantage is poor low-temperature impact resistance and easy aging.
High density polyethylene (HDPE) products have good wear resistance, electrical insulation, toughness and cold resistance; Good chemical stability, insoluble in any organic solvent at room temperature, resistant to acid, alkali and various salts; After it is made into oral liquid medicinal high-density polyethylene bottle, it has low permeability to water vapor and air and low water absorption; However, its aging resistance and environmental stress cracking resistance are poor, especially the thermal oxidation 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 nonvolatile substances to migrate to drugs, which will affect the safety of drugs.
The polyester material referred to in the oral solid medicinal polyester bottle is polyethylene terephthalate, which is referred to as pet, which belongs to high molecular compound. Polyethylene terephthalate (PET) is produced by polycondensation of terephthalic acid (PTA) and ethylene glycol (eg). It is widely used in packaging industry, electronic appliances, medical and health care, construction, automobile and other fields. Packaging is not only the largest non fiber application market of polyester, but also the fastest growing field of pet. Pet has good fiber forming, mechanical properties, wear resistance, creep resistance, low water absorption and electrical insulation. The advantages of oral liquid medicinal polyester bottle are light weight (only 1 / 9 ~ 1 / 15 of the weight of 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 in the production of polyester bottle, and renewable use of waste bottle. However, a certain proportion of lubricants, inorganic powders, coupling agents and other additives need to be added in the production process. Moreover, the temperature has a great impact on the finished products. If the temperature is not well controlled in the production process, it is also easy to have insufficient mechanical strength of the products. Therefore, the performance test of its finished products is a necessary condition to determine whether the quality is qualified.
1、 Tightness test and test method
Test instrument: njy-20 torque instrument of Labthink Jinan Languang Electromechanical Technology Co., Ltd. This instrument is a special equipment for testing the locking and opening torque value of bottle cap of packaging products, suction nozzle packaging products and hose packaging products. It has high measurement accuracy and good stability.
Labthink Jinan Languang Electromechanical Technology Co., Ltd. mfy-01 sealing tester, also known as sealing performance tester and sealing degree tester, is applicable to the leakage sealing performance test of packaging bags, bottles, tubes, cans and boxes in food, medicine, medical devices, daily chemical, automobile, electronic components, stationery, pesticide, veterinary medicine and other industries. It can also be used for leakage detection of aluminum-plastic blisters for drugs and sealing performance test of packages after drop and pressure test.
Test process: take a number of samples to be tested and place them on the njy-20 torque instrument. Under the torque indicated in Table 1 below, the bottle mouth and cap shall fit properly without tooth slippage.
After that, 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 mfy-01 sealing tester, vacuum the vacuum chamber, set the experimental parameters, make the vacuum degree reach 27kpa, and make the sample immersed in water produce internal and external pressure difference for 2 minutes. According to the standard ybb00122002-2015 \ ybb00112002-2015 \ ybb00262002-2015, there shall be no water or bubbles in the bottle.
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2、 Nonvolatile detection
Nonvolatile matter refers to the part in which the liquid or solid in the material cannot evaporate or sublimate into gas under specific circumstances. The nonvolatile substances in the packaging will migrate to the drugs and affect the quality and use effect of the drugs. Therefore, the determination of nonvolatile matter is very important to control the quality of oral solid medicinal bottles.
Test instrument: Labthink Jinan Languang Electromechanical Technology Co., Ltd. is a new generation of fully automatic high-efficiency C830 migration and nonvolatile determination instrument, which can be widely used in the determination of nonvolatile substances in various drug packaging materials. The equipment for the determination of volatile substances in the "2015 Chinese medicine package" does not meet the requirements of the latest GMP industry standard.
Test process: prepare the test solution, take three parts of the flat part with an internal surface area of 600cm2 (divided into small pieces with a length of 5cm and a width of 0.3cm), place them separately in a conical bottle with a stopper, add appropriate amount of water, shake and wash, and discard the water. Repeat the 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, cool it to room temperature, and supplement the same batch of test solvent to the original volume as the test solution. The experiment was carried out with the same batch of water, 65% ethanol and n-hexane as blank solution.
Accurately measure 50.0ml of water, 65% ethanol, n-hexane test solution and blank solution respectively, place them in the instrument, set C830 migration and nonvolatile matter tester, and dry them at 105 ℃ until constant weight. According to the standard ybb00122002-2015 \ ybb00112002-2015 \ ybb00262002-2015, the difference between water nonvolatile residue and blank residue shall not exceed 12.0mg; The difference between 65% ethanol nonvolatile residue and blank residue shall not exceed 50.0mg; The difference between n-hexane nonvolatile residue and blank residue shall not exceed 75.0mg.
3、 Detection and detection method of water vapor transmission
The main function of drug packaging is to protect the safety of drugs in the process of storage and transportation. Its water vapor transmission is an important index to measure whether the quality is qualified or not. The amount of water vapor passing through is large, and long-term storage and transportation will cause drugs to be affected by moisture and affect drug safety.
Test instrument: Labthink Jinan Languang Electromechanical Technology Co., Ltd. W3 / 030 water vapor transmittance tester is a professional water vapor transmittance tester for film samples based on the test principle of cup method. It is suitable for the determination of water vapor transmittance of plastic film, composite film and other films, sheet materials and medical materials. Through the measurement of water vapor transmittance, the technical indexes of controlling and regulating materials are achieved to meet the different needs of product application. The 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.
Test process:
(1) Container test shall be carried out according to the third method of standard YBB 00092003-2015. Add purified water with marked capacity into the sample and place it in the constant temperature and humidity box. The temperature accuracy is ± 0.6 ℃, and set the experimental temperature to 25 ℃± 2 ℃; Set the relative humidity to 95% ± 5%, the humidity accuracy of the constant temperature and humidity box to ± 2%, and place it for 24 hours. According to the standard ybb00122002-2015 \ ybb00112002-2015 \ ybb00262002-2015, each sample shall not exceed 100mg / 24h · L.
(2) Sheet test, take Φ The 74 mm sample to be tested shall be placed in the moisture permeable cup of W3 / 030 water vapor transmittance tester and clamped, and the moisture permeable cup shall be placed in W3 / 030 water vapor transmittance tester. Set the experimental temperature to 20 ℃± 5 ℃; Set the relative humidity as 65% ± 5% and the purging wind speed as 0.5-2.5m/s. When the penetration balance is reached on both sides of the sample, the system will shut down automatically and record the test results to see whether they meet the production quality control standards of the enterprise or the quality standards of the purchasing enterprise.
Labthink Languang is committed to helping customers deal with new packaging problems and help the quality and safety of packaging related industries through the improvement of packaging testing technology and the research and development of cutting-edge testing instruments. For more information, please follow the Labthink Languang wechat official account "Jinan Languang packaging safety inspection expert". |
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