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An important role in the validation process of wet heat sterilization: biological indicators
Date: 2025-07-30Read: 0
Wet heat sterilization refers to the method of sterilization using saturated steam, boiling water, or circulating steam. According to the sterilization equipment, it can be divided into high-pressure steam sterilization method, circulating steam sterilization method, and intermittent steam sterilization method. The core principle is to denature microbial proteins and destroy nucleic acids through a humid and hot environment, thereby achieving sterilization.
Although current sterilization equipment can accurately control physical parameters such as temperature, pressure, and time, these data can only prove that the equipment's operating status meets the preset standards (operational confirmation), but cannot verify the actual effectiveness of the sterilization process (performance confirmation). Ensuring the effectiveness of the sterilization process is precisely the most crucial link in ensuring product quality and safety.
How can we ensure the effectiveness of the sterilization process?
2025 edition of Chinese Pharmacopoeia 9207 "Guiding Principles for Biological Indicators for Sterilization"It is pointed out that in the validation of sterilization procedures, the degree of sterilization of biological indicators is the most intuitive indicator for evaluating a sterilization procedure.
From this, it can be seen that biological indicators play an important role in the sterilization validation process. So, what is a biological indicator?GB/T 18281.1-2024 "Sterilization biological indicators for healthcare products - Part 1: General principles"It is defined as follows: "Biological indicators refer to testing systems containing live microorganisms that have specific resistance to the prescribed sterilization process.
As a sterilization technology in the fields of healthcare and industrial production, wet heat sterilization relies on biological indicators to monitor sterilization effectiveness in the sterilization validation stage. Next, we will delve into the risk points and the application of biological indicators in the wet heat sterilization process.
01
Risk points during wet heat sterilization process
There are many factors that affect the effectiveness of wet heat sterilization, including steam quality, temperature uniformity, loading method, etc.
Residual cold air
Due to the poor thermal conductivity of cold air, in the initial stage of sterilization, if there is unfilled cold air in the chamber, it will hinder the effective penetration of steam, resulting in local temperatures that cannot meet sterilization requirements.
Temperature fluctuations and uneven heat distribution
Due to factors such as equipment aging, heating element failure, or unstable steam quality, some areas may experience low temperatures, which may prevent the necessary conditions for effective sterilization from being met.
Too much loading/Improper loading method
The placement and quantity of sterilized items directly affect steam flow and heat transfer. The larger the loading capacity, the longer the time required for heat transfer.Before the item reaches the set temperature, the effective sterilization time will be shortened, which may result inThe issue of current sterilization.
These potential factors may all lead to sterilization failure, and biological indicators act as "judges" to effectively evaluate the sterilization process, playing an irreplaceable role in ensuring sterilization effectiveness.
02
The application of biological indicators is ubiquitous from hospitals to factories
Wet heat sterilization is a commonly used sterilization method, which has the advantages of easy operation, reliable effect, and low cost, and is widely used in various fields
✅ medical field
In hospital operating rooms, disinfection supply centers, and other departments, biological indicators are used to monitor the sterilization effect of surgical instruments, dressings, syringes, and other medical supplies to ensure their sterility.
✅pharmaceutical industry
In the process of drug production, from production equipment to packaging materials, a sterile environment must be ensured. Biological indicators can monitor the sterilization process during drug production, ensuring the quality and safety of drugs.
✅food processing
Used to monitor the disinfection and sterilization effects during food processing, such as high-temperature sterilization of canned food and pasteurization of beverages, to ensure the hygiene quality of food and prevent food safety issues caused by microbial contamination.
✅laboratory environment
Researchers rely on sterile experimental equipment to obtain accurate data. The use of biological indicators can monitor the disinfection and sterilization effects of laboratory equipment and environment, ensuring the biological safety of the experimental environment.
✅Medical device manufacturers
In the production, assembly, and packaging of medical devices, it is necessary to monitor the sterilization effect of the production environment, tooling equipment, and finished products through biological indicators to ensure that the medical devices leaving the factory meet the corresponding standard requirements.
✅CDC (Centers for Disease Control and Prevention)
In scenarios such as epidemic prevention and control, pathogen laboratory disinfection, etc., biological indicators are used to monitor the disinfection and sterilization effects, ensuring the accuracy of sample testing and environmental biosafety.
...
Ensuring the reliability and verifiability of sterilization effectiveness is crucial in every application scenario of wet heat sterilization. Therefore, wherever there is moist heat sterilization, there is the presence of biological indicators.
03
Tailin provides a comprehensive wet heat sterilization validation solution
Tailin always adheres to high standard research and development, providingMulti type, multi parameter, stable performanceThe Biological Indicator SolutionTo ensure the effective implementation of wet heat sterilization validation.
✅Multiple types, adaptable to diverse scenarios
Provide three mainstream types of biological indicators that comprehensively cover different sterilization methods and usage environments:
• Carrier type biological indicator (tablet):Packaged from spores and carriers, suitable for verifying the sterilization effect of solid objects such as instruments, packaging materials, etc
Suspension based biological indicator:Suspension of spore suspension in liquid, specifically designed for liquid sterilization, widely used for validation of wet heat sterilization processes
• Self contained biological indicator:A system composed of spores and growth recovery medium, integrating spores and culture without transfer operations, avoiding cross contamination, and also suitable for verifying the sterilization effect of solid objects. Compared to tablet based biological indicators, self-contained biological indicators are easy to operate and do not require a sterile environment.
✅Dual temperature range optional, precisely matching sterilization conditions
According to different sterilization program settings, two common temperature standard products are provided:
• 121℃：Applicable to standard high-pressure steam sterilization procedures
• 115℃：Suitable for low-temperature sterilization process, meeting the sterilization needs of special equipment or sensitive materials
No matter which temperature range your sterilizer operates in, we can provide you with precise matching biological indicators.
✅Customized services to meet special needs
D value adjustable：Suitable D values can be selected based on sterilization intensity (such as D value ≥ 1.5 minutes) to simulate real challenges
Customization of spore quantity:Flexible adjustment of vaccination volume to meet different sensitivity verification requirements
04
Choosing the right indicator means choosing peace of mind and professionalism
As the main means of microbial challenge validation in sterilization procedures, biological indicators directly reflect the level of sterility assurance that the product can achieve in terms of killing.
Tailin Biological Indicator, with its research and development technology, mature production process, and reliable technical services, provides users with a full range of sterilization validation solutions, helping users efficiently complete the development and performance validation of sterilization processes.