Test method for water resistance of glass particles at 121 ℃

Abstract: the main characteristics of glass packaging containers are: non-toxic, tasteless; transparent, beautiful, good barrier, airtight, abundant raw materials, low price, and can be used repeatedly It has the advantages of heat resistance, pressure resistance and cleaning resistance It can be sterilized at high temperature and stored at low temperature Because of its many advantages, it is widely used in medicine and food industry Significance: the water resistance of glass particles is a routine test item of glass products On August 27, 2015, the State Food and Drug Administration issued the national standards for 130 packaging materials and containers (hereinafter referred to as "drug packaging materials") for direct contact with drugs, including YBB 00032005-2015 sodium calcium glass infusion bottle The new standard will be implemented from December 1, 2015 With the implementation of the new standard, pharmaceutical enterprises began to control the pharmaceutical packaging materials Injection bottle is one of the commonly used packaging for pharmaceutical enterprises How to carry out effective control and detection? We will explain the inspection equipment of pharmaceutical packaging materials independently developed by Jinan Saicheng Electronic Technology Co., Ltd., hoping to give reference and help to pharmaceutical enterprises in the use and purchase process 1、 According to the standard ybb00252003-2015 determination and classification of water resistance of glass particles at 121 ℃ 2 Applicable standard ybb000332005-2015 sodium calcium glass infusion bottle ybb00012004-2015 low borosilicate glass infusion bottle ybb000022005-2015 medium borosilicate glass infusion bottle ybb00332002-2015 low borosilicate glass ampule ybb00322005-2015 medium borosilicate glass ampule ybb00332003-2015 Sodium calcium glass injection bottle ybb000302002-2015 low borosilicate glass injection bottle ybb002005-2-2015 medium borosilicate glass injection bottle ybb002005-1-2015 high borosilicate glass injection bottle ybb00312005-2015 sodium calcium glass injection bottle ybb00322003-2015 low borosilicate glass injection bottle ybb000062005-2-2015 medium borosilicate glass injection bottle Ybb00032004-2015 sodium calcium glass tube oral liquid bottle ybb00282002-2015 low borosilicate glass tube oral liquid bottle ybb000022004-2015 borosilicate glass tube oral liquid bottle III test items, test methods, test instruments 1 Test items: [121 ℃ particle water resistance] [inner surface water resistance] 1.1 standard requirements [121 ℃ particle water resistance] take an appropriate amount of this product, and measure it according to the water resistance test method and classification (ybb00252003-2015) of glass particles at 121 ℃, which should conform to level 2 1.2 testing instrument △ pressure steam sterilizer △ beaker conical bottle △ oven △ hammer △ bowl and pestle, stainless steel screen △ electric sieve shaker 1.3 instrument parameter 1.3.1 bowl and pestle: made by quenching, size requirements 1.3.2 stainless steel screen: including a screen, 425 μ m aperture, B screen, 300 μ m aperture, O screen, 600-1000 μ m aperture 1.4 test method 1.4.1 preparation of test article (1) Beat the test object into pieces, take a proper amount of it and put it into the bowl, insert the pestle, and hit the pestle with a hammer once (2) Transfer the glass in the bowl to the o screen on the upper layer of the sieve, and repeat the above operation (3) Use the shaker to shake the cover screen (or manually shake the cover screen) for 5 minutes (4) Transfer the glass particles passing sieve a but remaining on sieve B to the weighing bottle, whichever is more than 10g, and prepare 3 parts in total (5) Remove the scrap iron from each glass particle with a magnet and transfer it into a 250ml conical flask (6) Wash the particles at least 6 times with anhydrous ethanol or acetone, 30ml each time, until anhydrous ethanol or acetone is clear (7) Place the conical flask with glass particles on the electric heating plate to heat, and remove the residual acetone or anhydrous ethanol (8) Transfer it to the oven for drying, take it out and put it into the dryer for cooling Storage time shall not exceed 24 hours 1.4.2 test method (1) Take 10.00g of the above glass particles respectively, accurately weigh them, place them in a 250ml conical flask, and precisely add 50ml of water (2) Put the beaker upside down on the conical flask and put the conical flask into the pressure steam sterilizer (3) Open the exhaust valve, heat at a constant speed, and let the steam out of the exhaust valve for 10 minutes (4) Close the exhaust valve, continue heating, and increase the temperature to 121 ℃ within 19-33 minutes (5) After maintaining at 121 ℃ for 30 ± 1 min, slowly cool down and depressurize, and reduce the temperature to 100 ℃ within 38-46 min (6) Remove from the autoclave and cool to room temperature Prepare blank solution by the same method Complete the titration within 1 hour (7) Add 4 drops of methyl red indicator solution (0.025g of methyl red sodium, add water to dissolve and dilute to 100ml) into each conical flask, titrate with hydrochloric acid titrant (0.02mol / L) to reddish color, and calibrate with blank solution 1.4.3 expression of test results: calculate the average value of titration results, which is expressed by the volume (ML) of hydrochloric acid titration solution (0.02mol / L) consumed per 1g of glass particles Classification: the water resistance of glass particles shall be classified according to the consumption (ML) of hydrochloric acid titration solution (0.02mol / L) according to the following table If you need to know more about pharmaceutical packaging products, please call Jinan Saicheng Electronic Technology Co., Ltd Jinan Saicheng looks forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!