KMNPack's Biological indicators

KMNPack's Biological indicators are a special type of living microbial products that can be used to confirm the performance of sterilization equipment, the verification of sterilization procedures, and the monitoring of sterilization effects in production processes. It is defined as a defined resistance to a specific sterilization process and is available in the inner packaging for the carrier

characteristic

Special live microbial products

Function

Confirm the performance of the sterilization equipment

Quality characteristics

Spore content

Basic Information

Biological indicators are a special type of living microbial products that can be used to confirm the performance of sterilization equipment, the verification of sterilization procedures, and the monitoring of sterilization effects in production processes.

Definition of biological indicator:

A defined resistance to a specific sterilization process, and a carrier for the bacteria to be used in the inner packaging. Used to confirm the performance of sterilization equipment, verification of sterilization procedures, monitoring of sterilization effects in production processes, etc.

Biological indicator classification:

1) According to the structure, it can be divided into a strip biological indicator and a self-contained biological indicator; a flaky biological indicator needs to use a positive control and a negative control, and a self-contained Biological indicators only need a positive control [1].

2) According to the classification of ISO 11138-1 (2006), current biological indicators include biological indicators for ethylene oxide sterilization, biological indicators for moist heat sterilization, biological indicators for dry heat sterilization, and hydrogen peroxide. Low temperature plasma sterilization biological indicators and biological indicators for formaldehyde sterilization [2].

3) According to the culture time, it can be divided into a general-purpose biological indicator and a rapid biological indicator. The universal biological indicator changes the pH value of the culture medium according to the metabolism of the indicator species after the spore resuscitation, and is judged by the discoloration of the acid-base indicator, and the time is generally 24 or 48 hours; and the rapid biological indicator is recovered according to the spore recovery. The enzymatic reaction is interpreted by fluorescence, and the time is usually 3-4 hours. At the same time, foreign countries are developing faster biological indicators, and it is expected to produce results within one hour.

Biological indicator weight quality characteristics:

1) Spore content

2) D value (measured by survival curve method)

Biological indicator manufacturer:

1) Foreign professional producers: American Johnson & Johnson, 3M, etc.;

2) Domestic professional producers: KANGMINGNA and others.

Biological indicator application

In the sterilization procedure verification, although the sterilization effect can be evaluated by monitoring certain parameters of the sterilization process, the degree of killing of the biological indicator is the most intuitive indicator for evaluating the effectiveness of a sterilization procedure. Commercially available standard biological indicators can be used, as well as spores prepared with the most tolerant microorganisms isolated in the daily production of contaminating bacteria monitoring. In the biological indicator verification test, the D value of the spore under actual sterilization conditions is determined, and the purity and quantity of the spore are determined. At the time of verification, the microbial amount of the biological indicator should be larger than the amount of microbial contamination detected daily, and the tolerance is strong to ensure greater safety in the sterilization process. In the final sterilization method, the biological indicator should be placed in different parts of the sterilizer. And avoid direct contact of the indicator to the sterilized item. The biological indicator is sterilized according to the set conditions, and then taken out and cultured in the medium to determine whether the spores in the biological indicator are completely killed.

Overkill product sterilization verification generally does not consider microbial contamination levels, and commercially available biological indicators can be used. For products that are poorly tolerated by sterilization methods, when designing the sterilization procedure, based on experience, the level of microbial contamination of the product in the production process is expected, and the number of species and spores of the biological indicator are selected. The sterility assurance of such products should be evaluated by monitoring the amount of microbial contamination prior to each batch of sterilization, tolerance, and data obtained from sterilization procedure validation.

In the sterilization biological monitoring of medical institutions, the standards have clearly stated:

1. The pressure steam sterilization process is once a week, using a pressure steam sterilization biological indicator;

2. Ethylene oxide gas sterilization is monitored for each batch, and ethylene oxide sterilization biological indicator is used;

3. Low temperature plasma sterilization is monitored once a day, using a low temperature plasma to sterilize the biological indicator.

The above three sterilization methods, pressure steam sterilization is the most widely used.