This article describes several issues that companies that manufacture pharmaceutical packaging materials should pay attention to when using and implementing the standard.
1. Thanks to YBB
In the standard, the increase of testing items and the improvement of testing requirements, the detection capacity of some production enterprises is still not up to the standard requirements, so it should be noted that the standards attached to the standards for the * shall be entrusted to the testing agency centralized by the State Drug Surveillance Agency at least once every six months. 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 the YBB00242003 "121 °C Water Resistance Measurement and Classification of Inner Surfaces" Standard Test, When Detected Every 100ml
When the etching solution consumes the maximum value of the titration solution of hydrochloric acid and checks the table, be careful not to describe the indication method wrong, especially when the glass container reaches HC1 and HC2 levels.
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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