Xilin bottles are mainly used for the packaging of various medicines. They are composed of rubber stoppers, aluminum-plastic composite covers and rubber stoppers. The quality of these components directly affects the performance of freeze-dried powder vials. With the promulgation of the new version of the pharmaceutical packaging materials, the state has stricter control over the quality of pharmaceutical packaging materials. The freeze-dried powder vial is a kind of medicinal glass bottle, and its practical performance is a problem that should be concerned by pharmaceutical factories, glass factories, packaging materials factories and quality inspection organizations. So what equipment is used to test the performance of freeze-dried powder vials?   The following small series mainly introduces the experimental equipment required for the physical testing of the lyophilized powder vial rubber stopper and aluminum-plastic composite cover. Freeze-dried powder vial sealability tester   1. Sealing performance test of freeze-dried powder vials;   1. Testing equipment: The inside of the vial is generally filled with sterile medicine. The standard of the medicine packaging material stipulates that it has strict sealing performance. Therefore, the lyophilized powder of the Sanquanzhongshi lyophilized powder sealant tester is used to detect the lyophilized powder and the sterile glass. The test of the self-tightness of the bottle and the rubber stopper.   2. Meet the standard: The sealing tester for freeze-dried powder vials meets GB/T15171, ASTM D3078, GB/T27728, YBBOOl12002-2015, YBB00122002-2015, YBB00262002-2015, YBB00052005-2015, YBB00092002-2015, YBB00392003-2015, YBB00112002-2015 and many other home-based standards.   3. The principle of sealing test of freeze-dried powder vial: the internal and external pressure difference is generated by the sample immersed in the vacuum chamber water, and the gas escape condition in the sample is observed to determine the sealing performance of the sample; The chamber is evacuated to make the sample have an internal and external pressure difference, and the specimen is inflated and the shape recovery of the sample and the liquid infiltration are observed after the vacuum is released, thereby determining the sealing performance of the sample.   Second, the test items of freeze-dried powder vial aluminum-plastic composite cover:   1. Freeze-dried powder vial aluminum plastic cover opening force test   The national pharmaceutical standards YBB00402003 and YBB00372003 all mention the test method for the opening force of the aluminum-plastic composite cover. The opening force of the aluminum-plastic composite cover consists of two parts: the removal force of the plastic part and the tearing force of the tear piece. The opening force of the aluminum-plastic cover of the freeze-dried powder can be used to test the tearing force tester YYB-01 of Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd.   Free-drying powder vial aluminum-plastic cap opening force test method;   The opening function of the freeze-dried powder vial aluminum plastic cover is to open the plastic cover at a tilting angle of 23° on a stretching device (medical packaging tear tester YYB-01) at a speed of 100 mm/min.   The tearing force of the tearing sheet is suitable for the ZD or OD type aluminum piece tearing piece, and the appropriate amount of the bottle cap is taken. The hook is on the exposed tearing piece, and the test speed is 100mm/min±10mm/ on the stretching device (medical packaging tearing force tester). Min until the cap is completely torn open. Medical packaging tearing force tester YYB-01   2. Freeze-dried powder Westwood bottle rubber plug penetration test   Testing equipment and meeting the standard: YBB00042005 Injectable sterile powder with halogenated butyl rubber plug has a clear test method for puncture force and puncture and falling off, and YYB-01 medical packaging tearing force tester produced by Sanquan Zhongshi.   Freeze-dried powder Westwood bottle rubber plug stab force test equipment YYB-01 medical packaging tear strength tester is a special instrument for testing polypropylene combination cover, various brominated butyl tape, halogenated butyl tape puncture force, instrument work fine, can Placed on the table, the personnel are easy to operate, adding different fixtures can complete different tests, pull ring opening force test, aluminum-plastic composite cover opening force test, ampoule breaking force test, large LCD screen display, real-time display force value, display test The curve, the instrument uses imported sensors, is a top instrument on the market.   3. Freeze-dried powder vial rubber stopper and container adhesion test   Take 10 of this product, put it in a beaker, add water for 5 minutes, take it out, dry it at 70 °C for 1 hour, and set aside. In addition, take 10 matching injection bottles and add water to the marked capacity. Use the above rubber stopper to plug, and then add the aluminum cover and press cover. Place in a high pressure steam sterilizer, hold at 121 ° C ± 2 ° C, hold for 30 minutes, cool to room temperature, and let stand for 24 hours. The above sample was inverted, placed in a container containing 10% methylene blue solution, placed in a container with a suction device, evacuated to a vacuum of 25 KPa, maintained for 30 minutes, the vacuum device was returned to normal pressure, and then placed 30 In minutes, remove and rinse the outer wall of the bottle with water. Observe that the methylene blue solution must not penetrate into the bottle.   The vial bottle is the main form of packaging for sterile powdered medicines, and it is used in large quantities. With the continuous development of the pharmaceutical industry, pharmaceutical companies hope that products can be quickly listed, while saving production and operating costs. How to make more and more economical and faster production of a variety of dosage forms and various sizes of vial products has become a new topic. At this time, it is obviously inappropriate to rely solely on the simple stacking of production equipment. Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. provides a reasonable and rigorous experimental experiment for pharmaceutical, glass and packaging plants from the perspective of production technology. Room solution. Hotel Safe,Guest Room Safe,Mini Safe Box,Digital Safe Box Hebei Yingbo Safe Boxes Co.,Ltd , https://www.ybsafebox.com
