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Some understandings on the new industry standards for pharmaceutical controlled glass bottles

in order to effectively control the quality of drug packaging materials and improve the safety of drugs when they are packed, the State Food and drug administration has successively issued a number of industry standards in the three years from 2002 to 2004. These standards beginning with YBB involve more testing items than those specified in the original national standards, and the requirements are improved, especially for pharmaceutical glass containers. For example, all kinds of pharmaceutical glass bottles have increased the requirements for the thermal expansion coefficient of glass, the content of boron oxide and the leaching amount of arsenic, antimony and lead

this paper expounds several problems that should be paid attention to in the use and implementation of the standard by enterprises producing drug packaging materials

1. Due to the increase of testing items and the improvement of testing requirements in the YBB standard, the testing ability of some manufacturing enterprises can not meet the standard requirements, so it should be noted that the items with * in the standard should be entrusted to the testing institution under the jurisdiction of the national drug supervision department at least once every six months. When the source of raw materials and process conditions change, the inspection shall be entrusted in time to prove the conformity of the materials used

in addition, qualified manufacturers of drug packaging materials should provide necessary testing equipment, instruments and chemicals as soon as possible to ensure the conformity of product quality, which can also reduce more quality costs for enterprises

2. In the process of using YBB "121 ℃ internal surface water resistance determination and classification" standard detection, when the maximum consumption of hydrochloric acid titrant per 100ml of etching solution is measured and the table is checked, be careful not to describe the expression method incorrectly, especially when the glass container reaches HC1 and HC2 levels

the inspector must make clear the name of the material used in the container and the processing method, because although HC1 and HC2 are in the same column of the standard, they are applicable to the expression of containers made of different materials and processing methods. Grade HC1 is applicable to the classification of containers made of borosilicate glass, and grade HC2 is applicable to the classification of glass containers made of soda lime glass with treated inner surface, such as glass containers that will promote the investment of new equipment through neutralization process

in addition, when issuing the test report, the expression method should be: water resistance grade of borosilicate glass container YBB - HC1; Sodium calcium glass container water resistance level YBB has more than 90% of the cargo pallets are made of wood - HC2

3. Pay attention to the use of reference dimensions recommended in YBB Standard

many reference dimensions are listed in YBB standard, which are formed after considering many factors comprehensively when formulating the standard, so it is of great reference significance to guide the production or design of new glass bottles

for example, the data requirements for the full mouth capacity of low borosilicate glass tube oral liquid bottle. Usually, pharmaceutical companies have a high-temperature sterilization process after the filling of oral liquid. If the full mouth capacity of the low borosilicate glass tube oral liquid bottle is designed to be too small, the boiling liquid will form a strong thermal shock on the inner wall of the glass bottle. If the strength of the glass bottle itself cannot withstand the thermal shock, it will often cause losses due to damage. Of course, it can't be designed too large, which will increase the cost and affect the visual effect of buyers