Glass 121 ° C particle water resistance test method
Abstract: The main features of glass containers are: non-toxic, tasteless; transparent, beautiful, good barrier, airtight, rich in raw materials generally, low price, and can use multiple turnover. It has the advantages of heat resistance, pressure resistance and washing resistance. It can be sterilized at high temperature or stored at low temperature. Because of its many advantages, it is widely used in the pharmaceutical and food industries.
Significance: Water resistance of glass particles is a routine test item for glass products. On August 27, 2015, the Food and Drug Administration announced in Announcement No. 164 of 2015 that 130 pieces of packaging materials and containers for direct contact with drugs such as YBB 00032005-2015 Sodium Calcium Glass Infusion Bottles were issued (hereinafter referred to as “medical packaging materialsâ€). National standard. The new standard will be implemented on December 1, 2015.
With the implementation of the new standards, pharmaceutical companies began to control the pharmaceutical packaging materials. Injectable bottles are one of the commonly used packaging for pharmaceutical companies. How to carry out effective control and testing, we combine the self-developed pharmaceutical packaging materials of Jinan Saicheng Electronic Technology Co., Ltd. The testing equipment will be explained one by one, and it is hoped that the pharmaceutical enterprises will give reference and help in the process of use and procurement.
First, according to the standard
YBB00252003-2015 Glass granules at 121 ° C water resistance determination and classification
Second, applicable standards
YBB00032005-2015 sodium calcium glass infusion bottle
YBB00012004-2015 low borosilicate glass infusion bottle
YB00022005-2015 borosilicate glass infusion bottle
YBB00332002-2015 "Low borosilicate glass ampoule"
YBB00322005-2015 "Chinese borosilicate glass ampoule"
YBB00332003-2015 Sodium Calcium Glass Control Injection Bottle
YBB00302002-2015 low borosilicate glass controlled injection bottle
YBB00292005-2-2015 borosilicate glass controlled injection bottle
YBB00292005-1-2015 high borosilicate glass controlled injection bottle
YBB00312005-2015 soda lime glass molding injection bottle
YBB00322003-2015 low borosilicate glass molding injection bottle
YBB00062005-2-2015 Zhongpeng Silica Glass Molding Injection Bottle
YBB00032004-2015 sodium calcium glass controlled oral liquid bottle
YBB00282002-2015 low borosilicate glass controlled oral liquid bottle
YBB00022004-2015 borosilicate glass controlled oral liquid bottle
Third, testing items, testing methods, testing equipment
1. Test items: [121 ° C particle water resistance] [internal surface water resistance]
1.1 standard requirements
[121 ° C particle water resistance] Take the appropriate amount of this product, according to the glass particles in the 121 ° C water resistance determination method and classification (YBB00252003-2015) determination, should meet the level 2.
1.2 Testing equipment
â–³ pressure steam sterilizer â–³ beaker cone
â–³ oven â–³ hammer
â–³ Milling and smashing, stainless steel screen â–³ electric vibrating screen machine
1.3 Instrument parameters
1.3.1 Milling and boring: Made by quenching, size requirements.
1.3.2 Stainless steel screen: Contains A sieve, pore size 425μm, B sieve, pore size 300μm, O sieve, pore size 600~1000μm.
1.4 Detection method
1.4.1 Preparation of the test article.
(1) Hit the test piece into pieces, take an appropriate amount into the smash, insert the sputum, and slam it once with a hammer.
(2) Transfer the glass in the ramie to the O-screen of the upper layer of the sifter and repeat the above operation.
(3) Vibrate the sieve with a vibrating screen (or shake the sieve by hand) for 5 minutes.
(4) Transfer the glass particles passing through the A sieve but remaining on the B sieve into a weighing bottle, which is more than 10 g, and prepare a total of 3 portions.
(5) Remove the iron filings from each glass granule with a magnet and transfer to a 250 ml Erlenmeyer flask.
(6) The particles are washed with absolute ethanol or acetone at least 6 times, 30 ml each time, until the absolute ethanol or acetone is clear.
(7) The Erlenmeyer flask containing the glass particles is placed on a hot plate to remove residual acetone or absolute ethanol.
(8) Transfer to the oven for drying, take out, and cool in a desiccator. Storage time must not exceed 24 hours.
1.4.2 Test methods.
(1) Take 10.00 g of the above glass particles separately, accurately weigh them, place them in a 250 ml Erlenmeyer flask, and precisely add 50 ml of water.
(2) Invert the flask to the conical flask and place the conical flask into the pressure steam sterilizer.
(3) Open the exhaust valve and heat it at a constant speed to allow steam to be ejected from the exhaust valve for 10 minutes.
(4) Close the exhaust valve and continue heating. Increase the temperature to 121 °C in 19~33 minutes.
(5) After maintaining at 121 ° C for 30 ± 1 minutes, slowly cool and depressurize, and reduce the temperature to 100 ° C in 38 to 46 minutes.
(6) Remove from the pressure steam sterilizer and cool to room temperature. A blank solution was prepared by the same method. The titration was completed in 1 hour.
(7) Add 4 drops of methyl red indicator solution (methyl red sodium 0.025 g, dissolved in water and diluted to 100 ml) to each conical flask, and titrate to a reddish color with hydrochloric acid titration solution (0.02 mol/L). Blank solution correction.
1.4.3 Test results
The results indicate that the average value of the titration results was calculated and expressed as a volume (ml) of hydrochloric acid titration solution (0.02 mol/L) per 1 g of glass particles.
Classification: The water resistance of the glass particles should be classified according to the consumption (ml) of the hydrochloric acid titration solution (0.02 mol/L) as shown in the following table.
If you need to know more about pharmaceutical packaging products, please call Jinan Saicheng Electronic Technology Co., Ltd., Jinan Saicheng is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!
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