Suspension type biological indicator and preparation method thereof

Abstract

The invention provides a suspension type biological indicator of which the stability is good and spores are not easy to sprout. The biological indicator comprises a plastic tube of which the two ends are sealed by fusing, wherein bacterial tablets and a culture medium ampoule tube are arranged in the plastic tube; the invention further provides the preparation method of the biological indicator, and the preparation method comprises the following steps: sealing one end of the plastic tube by fusing for standby application; allowing a hydrophilic support to carry a specified number of spores and drying the spores to form the bacterial tablets, and encapsulating a recovery medium with pH indicating liquid in a glass tube to form the culture medium ampoule tube; placing the bacterial tablets and the culture medium ampoule tube in the plastic tube, and sealing the other end of the plastic tube by fusing. According to the suspension type biological indicator and the preparation method thereof, provided by the invention, the spores are in a dry state and the quality stability of the products is improved, during storage, the spores are isolated from the liquid recovery medium, therefore the spores do not grow, even the storage temperature is the same as the spore growth temperature, and the biological indicator can be stored at room temperature. The suspension type biological indicator can serve as indicator bacteria of various spores that are different in growth temperatures.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a biological indicator of a sterilized instrument. Background technique [0002] In the verification of sterilization procedures, when the object to be sterilized is liquid and is sterilized by pressure steam, such as the sterilization of large infusions and small injections, most of the current methods are to mix spores with liquid recovery medium containing pH indicator solution and then The biological indicator sealed and filled in the glass ampoule is used as the indicator for monitoring. When sterilizing, the indicator is put into the liquid to be sterilized and goes through the sterilization process together. After the sterilization at constant temperature for a specified time, when the biological indicator culture solution does not change color, it indicates that the pH value of the culture solution has not changed, and there is no reproduction of microorganisms, and the ster...

AI Technical Summary

Problems solved by technology

[0003] However, the existing above-mentioned biological indicators usually have the following defects: all these biological indicators require low temperature preservation at 2°C-8°C, and because the spores and the culture medium are mixed together and can contact each other, it can cause 1. The spores are easily Germination, resulting in a significant decrease in the resistance of the biological indicator, and the loss of the significance of using the indicator for detection; 2. If the storage temperature reaches the growth temperature of the strain, the spores in the biological indicator will germinate and grow, resulting in the failure of the biological indicator

Images