Equipment and method for measuring micropore leakage rate of injection glass container

Abstract

The invention relates to equipment and a method for measuring the micropore leakage rate of an injection glass container. The measuring method comprises the following steps: 1) opening the exhaust valve and the second valve until the pressure inside and outside the constant volume chamber is consistent, and connecting a glass container for injection to be measured; 2) closing the exhaust valve and the second valve, opening the first valve and the vacuum pump, closing the first valve and the vacuum pump when the pressure of the constant volume chamber is reduced to be stable, and recording the pressure value; 3) opening the second valve, and recording the pressure change value and the corresponding time; 4) calculating the leakage rate and the conductance; and 5) substituting the conductance into an equivalent diameter formula to obtain the equivalent diameter of the micropore. According to the invention, the formula of the conversion relation between the leakage rate and the equivalent diameter is established, the equivalent diameter of the micropore can be accurately measured, and the metering test fixed value of the micropore leakage positive sample of the injection glass container can be autonomously carried out, so that the test period of domestic injection sealing performance verification is shortened, and the related detection cost is reduced.

Description

Technical field [0001] The present invention belongs to the technical field of pharmaceutical packaging detection, and more particularly to measuring equipment and method of microporous leakage of injection glass container. Background technique [0002] In the pharmaceutical industry, the bottle-shaped glass container is generally used to hold the injection, and the glass container can isolate the injective injective to the outside to maintain effectiveness; when the hole or crack is present on the glass container, the bacteria can enter the glass container through holes or cracks into the glass container. Pollution to the injection; in order to study the relationship between the size of the glass container or the size of the fracture and bacterial intrusion, and the detection verification of the leakage level of the injection glass container (i.e., the sealing verification), visible, positive sample in sealing performance verification It is an important reference to the referenc...

AI Technical Summary

Problems solved by technology

[0005] Aiming at the above-mentioned deficiencies in the prior art, the technical problem to be solved by the present invention is to provide a measurement device and method for the micropore leakage of glass containers of injections, so as to solve the problem that the micropore size of positive samples cannot be independently measured and determined in China at present. To solve the problem, provide a new solution and new choice for the industry, which can shorten the test cycle and reduce the test cost of the injection glass container sealability verification, and may become a new industry standard

Images