Some understanding of the new industry standard for medicinal glass bottles
In order to effectively control the quality of drug packaging materials and improve the safety of drug packaging, the State Food and Drug Administration issued a number of industry standards in succession from 2002 to 2004. These standard contents beginning with YBB involve more testing items than those specified in the original national standards, and at the same time, their requirements have been increased, especially for medicinal glass containers. For example, various medicinal glass bottles have increased the requirements for the thermal expansion coefficient of glass, the content of boron oxide, and the amount of leaching of arsenic, antimony, and lead.
This article describes several issues that companies that manufacture pharmaceutical packaging materials should pay attention to when using and implementing the standard.
1. Due to the increase in testing items and detection requirements in the YBB standards, the detection capabilities of some manufacturers are still not up to standard requirements. Therefore, it is necessary to pay attention to the items entrusted with the * in the standard to entrust at least half a year to the national drug supervision authority. The detection agency detects once. When the source of raw materials and the process conditions are changed, the inspection shall be commissioned in time to prove the conformity of the materials used.
In addition, qualified drug packaging material manufacturers should quickly complete the necessary testing equipment, instruments, and chemicals used to ensure the conformity of the quality of the manufactured products. This can also reduce more quality costs for the company.
2. When using YBB00242003 "121 °C internal surface water resistance test method and grading" standard detection process, when measuring the maximum value of hydrochloric acid titration solution per 100ml of etch liquid and checking table, be careful not to describe the method of description wrong Especially when glass containers reach HC1 and HC2 grades.
The tester must find out the name of the material used for the container being tested and the processing method used for processing, because although the HC1 and HC2 grades are in the same column of the standard, the two are suitable for the expression of containers made of different materials and processing methods. the way. The HC1 grade is suitable for grading containers made of borosilicate glass, and the HC2 grade is suitable for grading glass containers with interior surfaces made of soda-lime glass, such as glass containers treated by a neutralization process.
In addition, when the test report is issued, the indication method should be: borosilicate glass container water resistance level YBB00242003 - HC1; soda lime glass container water resistance level YBB00242003 - HC2.
3. Pay attention to the use of reference dimensions recommended in the YBB standard Many reference dimensions are listed in the YBB standard. When the standards are formulated, many factors are taken into consideration. Therefore, it is very helpful to guide the production or design of new glass bottles. meaningful.
For example, data requirements for the full mouth capacity of low-borosilicate glass-controlled oral fluids. Usually, the pharmaceutical company has a high-temperature sterilization process after the oral liquid filling is completed. If the full mouth capacity of the low-borosilicate glass controlled oral liquid bottle is designed to be too small, the boiling liquid will form a strong thermal shock to the inner wall of the glass bottle if the glass The strength of the bottle itself cannot withstand thermal shocks, and losses are often caused by breakage. Of course, it cannot be designed too much. This will increase the cost and affect the buyer's visual effect.
As another example, in the standard for low-borosilicate glass controlled injection bottle, the reference data for r1 and r2 is specified. R1 is the radius of curvature at the shoulder of the bottle and r2 is the radius of curvature at the junction between the bottle body and the bottom of the bottle. The degree of over arcing between the two often directly affects the degree to which the glass bottle can withstand vertical loads. Because the sleek over-structure avoids stress concentration at the transition, the size of the r1 and r2 parameters affects the strength of the bottle. Therefore, it is necessary to adjust the suitability of the filling machine used by the customer and select different strength materials so as to reduce and avoid the loss caused by the damage of the bottle.
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