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Quality standard for neutral borosilicate glass controlled injection bottles

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[Abstract]:
Quality standard for neutral borosilicate glass controlled injection bottles

Quality standard for neutral borosilicate glass controlled injection bottles

 

Description of standard item establishment and requirements

1. The name according to the standard formulated requirements, drug packaging materials standards should be divided according to the material, a material (variety) a standard;The standard name shall follow the sequential format of materials, applications and shapes.Therefore, the name of this standard is proposed as medium borosilicate glass controlled injection bottle. 

2. The definition is defined as a clear definition of borosilicate glass controlled injection bottles to distinguish glass bottles produced by different glass materials and different production processes.

3. The appearance according to the quality requirements of the glass production and processing technology, combined with the description of real samples, should be able to fully reflect the quality of the product.

4. The main difference between neutral glass and low-borosilicate glass and sodium-calcium glass is that it has good thermal stability and chemical stability. The online thermal expansion coefficient and the content of boron trioxide are also different from 3.3 borosilicate glass.Accordingly, the identified item is:

(1) linear thermal expansion coefficient: it is one of the main physical properties of glass, which determines the thermal stability of glass, that is, the ability of glass to withstand drastic changes in temperature, and the linear thermal expansion coefficient is mainly determined by the chemical composition of glass.Therefore, the linear thermal expansion coefficient can be used to control the performance of glass and reflect the type of glass components.The linear thermal expansion coefficient of neutral glass should be (4 ~ 5) ×10-6k-1(20℃ ~ 300℃).

(2) boron trioxide content: it is the main component to improve the thermal and chemical stability of glass, and in a certain range, with the increase of its content, the better the performance of glass.Therefore, the determination of boron trioxide content as an identification item can control the performance of glass and reflect the type of glass components.The content of B2O3 in neutral glass should be 8% ~ 12% (g/g). 

5. Water resistance by particle method at 121℃:Methods the water resistance of glass particles at 121℃ was measured and graded (YBB00252003).Control the chemical stability of glass material. 

6.  98℃ particle method water resistance: Methods the water resistance of glass particles was measured at 98℃ (YBB00362004).The water resistance of 98℃ particles is an important method widely used in the world to test the water resistance of glass.Neutral glass material should meet the requirements of hgb1 level.Control the chemical stability of glass material. 

7. Water resistance of inner surface: Methods water resistance test method and classification (YBB00242003) were adopted at 121℃.Control the chemical stability of the glass bottle.

8. Acid resistance: It is mainly to test the degree of acid etch resistance of glass, so as to quantitatively determine the grade of acid resistance.The first method is gravimetric method, which is determined according to the determination of boiling hydrochloric acid etch resistance of glass (YBB00342004).Neutral glass shall meet the requirements of grade 1.The second method is flame spectrometry, and the second method is YBB00342004.According to the amount of alkaline oxide precipitated per unit surface area of the glass to determine whether it is qualified.Neutral glass should be less than or equal to 100 mu /dm2.Control the chemical stability of the glass bottle. 

9. Alkali resistance: The degree of tolerance of glass to mixed alkali etch is mainly tested to determine the degree of alkali resistance of glass quantitatively.Methods: according to the determination of etch resistance of glass to boiling mixed alkaline water solution (YBB00352004), neutral glass should meet the requirements of grade 2.Control the chemical stability of the glass bottle. 

10. Internal stress: Methods the internal stress measurement method (YBB00162003) was adopted.Control the annealing level of glass bottles.

11. Heat resistance: Take proper amount of this product, put it into the oven, heat it to 180℃ within 30 min and keep the temperature for 2 hours, then take it out immediately to check that there is no rupture.Control the heat resistance of glass bottles. 

12. Freezing resistance: Take an appropriate amount of this product, inject 1/2 of the nominal capacity of water into the freezer, the temperature is controlled at -41 ±2℃.After 24 h, it was immediately put into 40±1℃ water. After 1 min, it was taken out and no rupture was detected.Control the low temperature performance of glass bottles.

13. Leaching amount of arsenic, antimony, lead and cadmium: Methods the leaching amount of arsenic, antimony, lead and cadmium was measured (YBB00372004).SSb acuities were 0.7 mg/l;Pb acuities were 1.0 mg/l;Cd acuities were 0.25 mg/l.Ensure the safety of injection bottles. 

14. Deviation of vertical axis: Methods the vertical axis deviation measurement method (YBB00192003) was adopted.Control the flatness of the bottom surface of the container and the symmetry of the whole.

Taian Youlyy Industaial co., ltd. was established in 2012, is a collection of design, production, sales in one of the modern, new medical packaging manufacturing enterprises, the company's main products are glass bottles, various medical aluminum cover and aluminum plastic combination cover.The company strictly adheres to the standardized production in accordance with GMP, and the product quality is higher than the national standard of pharmaceutical packaging materials, and has been published by the registration number of the national pharmaceutical examination center.

 

Our company will be stable and reliable products, integrity, professional, efficient, rigorous service back to customers, return to the community.Also welcome all sectors of the community pharmaceutical enterprise colleagues to the company guidance, business negotiations.