Why do we need to punch ampoules?

Evaluate whether the container closure system is sufficient to maintain a sterile barrier against potential pollutants, in order to determine the potential pollutants that may cross the container closure barrier, including microorganisms, reactive gases, and other substances (USP), to ensure the sterility and product quality of the final drug, organism, and vaccine products throughout the entire shelf life.

How to evaluate and test is particularly important. Container closure integrity testing can be performed in many different ways, with each testing method having its own advantages and disadvantages. However, some containers (such as ampoules) require 100% integrity testing

The necessity of punching ampoule bottles:

To comply with regulations, it is necessary to create positive and negative controls for ampoule bottle testing. When designing and assembling controls, it is important to consider the container sealing design, structural materials, expected packaging leakage characteristics, and the impact of product content on test results (USP). Positive control is required to simulate defects in the container lid. However, naturally occurring leaks are rarely uniform holes or channels. They are usually complex winding paths (USPs). Usually, the control is tested together with the complete sample.

So with the help of laser beam drilling, even extremely hard materials can be easily processed. One of the advantages of this technology is that during the machining process, the size of the drill hole can be set to an accuracy of 1 micrometer. In this process, first, a short pulse, high-energy density laser beam heats the material to its melting point. The result of further irradiation is that the laser beam vaporizes the melted material, which is then eliminated from the borehole by the pressure caused by the steam generated during the process. This technology can achieve drilling with a depth of 20 units and a width of 1 unit. The beam source for laser beam welding is usually a peak pulse power pulse laser. By using high-speed, high-energy pulses, the formation heat affected zone around the borehole can be minimized or eliminated. Laser drilling of micron sized glass ampoule bottles creates leakage holes that can be infinitely close to real leakage holes.