Borosilicate Medicinal Neutral Glass Tube Vial Coe 5.0 ISO

COE 5.0 Borosilicate Medicinal Neutral Glass Tube

Production method of glass vials
【Technical field】
The present invention relates to a method for the production of glass vials, in particular medicinal vials or medicinal ampoules, and glass vials produced therefrom.
【Background technique】
[0002] Glass bottles for medicinal purposes (also called so-called "vials") consist of neutral glass, i.e. glass that can be classified as hydrolysis class 1, for which the standardized test ISO 719 (DIN 12111) is also used. In particular borosilicate glasses such as DURAN® or Fiohx® (both are registered trademarks of SCHOTT AG, Mainz) are neutral glasses.
[0003] Pharmaceutical vials or pharmaceutical ampoules, respectively, must additionally have as low an alkali metal emission as possible, wherein the measurement is carried out according to the standardized test ISO 4802. Furthermore, so-called delamination, ie spalling of regions on the glass surface, caused by glass constituents which evaporate and deposit on the glass surface, in particular during thermoforming, must be avoided. That is, in the most severe cases, such a delamination can enter the contents of the pharmaceutical vial and thus can destroy the contents.

Physic properties

Features

◆ GMP production environment

◆ Online statistical control

◆ meet ISO size and appearance AQL level

◆ detecting camera parameters and critical size defects in appearance key 77

◆ Each product can be traced to the time of delivery (DD-MM-YY), shift, machine and operator.

1, rotation speed: in a centrifuge tube expansion process, the rotational speed and diameter determined centrifugal force. When the diameter is constant, the higher the speed, the greater the centrifugal force. Under centrifugal force, the larger the diameter, the slower the speed. Thus, during the pipe expansion rate should be used as the basis to the diameter of the glass tube

2, the wall thickness is determined, and the corresponding temperature. Heating and softening the pressure in the pipe expansion process, the control diameter sizing device mainly depends on a set of synchronous rotation of the glass tube, it requires a wider range of speeds.

principle

The purpose is to eliminate permanent stress and structural imbalance in glass products. Glass is a poor heat conductor. After the product is formed, a temperature difference occurs between the surface layer and the inner layer during the cooling process. When the surface layer is solidified and the inner layer is viscous, the temperature difference exists but the stress relaxation does not exist. This temperature difference is when the surface layer is cooled to room temperature. , the inner layer continues to cool down and shrink, and is hindered by the surface layer to generate tensile stress, and at the same time, the surface layer generates compressive stress, which exists permanently