How to adjust the sterilization parameters of an Industrial Eto Sterilizer?
As a reputable supplier of Industrial Eto Sterilizers, I understand the critical importance of properly adjusting the sterilization parameters for these machines. Ethylene Oxide (EtO) sterilization is a widely used method in various industries, including medical device manufacturing, pharmaceuticals, and food processing, due to its effectiveness in killing a broad spectrum of microorganisms, including bacteria, viruses, and fungi, without causing significant damage to heat - or moisture - sensitive materials. In this blog, I will share some key insights on how to adjust the sterilization parameters of an Industrial Eto Sterilizer.
Understanding the Basics of Eto Sterilization
Before delving into parameter adjustment, it's essential to have a basic understanding of Eto Sterilization. Eto sterilization is a low - temperature process that involves exposing the items to be sterilized to ethylene oxide gas in a sealed ETO Sterilization Chamber. The process typically consists of several phases: pre - conditioning, gas introduction, exposure, and aeration.
The effectiveness of Eto sterilization depends on several factors, including the concentration of ethylene oxide gas, temperature, humidity, exposure time, and the nature of the items being sterilized. Adjusting these parameters correctly is crucial to ensure that the sterilization process meets the required standards of sterility assurance.
Concentration of Ethylene Oxide Gas
The concentration of ethylene oxide gas is one of the most critical parameters in the sterilization process. The appropriate gas concentration depends on the type of items being sterilized and the level of microbial contamination. Generally, higher concentrations of ethylene oxide can achieve faster sterilization, but they also pose greater risks to operators and the environment.
When adjusting the gas concentration, it's important to follow the manufacturer's recommendations. Most Industrial Grade Ethylene Oxide Sterilizers are designed to operate within a specific range of gas concentrations. For example, in medical device sterilization, the gas concentration may range from 300 to 1200 mg/L.
To determine the optimal gas concentration, you may need to conduct validation studies. These studies involve testing the sterilization process with different gas concentrations on representative samples of the items to be sterilized. The samples are then analyzed to determine the level of microbial kill. Based on the results of these studies, you can select the gas concentration that provides the desired level of sterility assurance while minimizing the use of ethylene oxide.
Temperature
Temperature also plays a significant role in Eto sterilization. Higher temperatures generally increase the rate of chemical reactions between ethylene oxide and microorganisms, leading to more effective sterilization. However, excessive temperatures can damage heat - sensitive materials.
Most Industrial Eto Sterilizers allow you to adjust the temperature within a certain range. The typical temperature range for Eto sterilization is between 37°C and 63°C. When selecting the temperature, consider the heat tolerance of the items being sterilized. For example, if you are sterilizing heat - sensitive medical devices, you may need to choose a lower temperature.
It's important to maintain a stable temperature throughout the sterilization process. Fluctuations in temperature can affect the consistency of the sterilization results. Use a reliable temperature control system to ensure that the temperature remains within the desired range.
Humidity
Humidity is another important factor in Eto sterilization. Ethylene oxide reacts with water molecules to form glycols, which can enhance the penetration of the gas into the materials being sterilized and improve the sterilization effect.
The optimal humidity level for Eto sterilization typically ranges from 30% to 80%. Before starting the sterilization process, you need to pre - condition the items to achieve the appropriate humidity level. This can be done by introducing steam or water vapor into the sterilization chamber.
Monitoring the humidity level during the sterilization process is crucial. Use a humidity sensor to measure the humidity in the chamber and adjust the steam or water vapor input as needed to maintain the desired humidity level.
Exposure Time
The exposure time refers to the duration for which the items are exposed to ethylene oxide gas. The appropriate exposure time depends on the gas concentration, temperature, humidity, and the nature of the items being sterilized.
Longer exposure times generally result in more effective sterilization, but they also increase the processing time and energy consumption. To determine the optimal exposure time, you can refer to the sterilization validation data provided by the manufacturer or conduct your own validation studies.
During the exposure phase, it's important to ensure that the items are evenly exposed to the ethylene oxide gas. This can be achieved by proper loading of the items in the sterilization chamber and using a circulation system to ensure uniform gas distribution.
Aeration
After the exposure phase, the items need to be aerated to remove any residual ethylene oxide. Residual ethylene oxide can be harmful to humans and may also affect the performance of the sterilized items.
The aeration process typically involves exposing the items to fresh air or using a vacuum system to remove the gas. The aeration time depends on several factors, including the gas concentration, temperature, humidity, and the nature of the items being sterilized.
To ensure effective aeration, you can adjust the aeration parameters, such as the air flow rate and the aeration time. The air flow rate should be sufficient to remove the residual ethylene oxide quickly, while the aeration time should be long enough to ensure that the residual gas levels meet the safety standards.
Monitoring and Validation
Once you have adjusted the sterilization parameters, it's important to monitor the sterilization process regularly to ensure that it remains within the established limits. Use sensors to monitor the gas concentration, temperature, humidity, and exposure time during each sterilization cycle.
In addition to regular monitoring, you should conduct periodic validation studies to verify the effectiveness of the sterilization process. Validation studies involve testing the sterilization process with biological indicators (BIs) and chemical indicators (CIs). BIs are living microorganisms that are used to assess the sterilization effectiveness, while CIs are chemical substances that change color in response to the sterilization conditions.
If the monitoring results or validation studies indicate that the sterilization process is not meeting the required standards, you may need to re - evaluate and adjust the sterilization parameters.
Conclusion
Adjusting the sterilization parameters of an Industrial Eto Sterilizer is a complex process that requires a thorough understanding of the Eto sterilization process and the factors that affect its effectiveness. By carefully adjusting the gas concentration, temperature, humidity, exposure time, and aeration parameters, you can ensure that the sterilization process provides the desired level of sterility assurance while minimizing the risks to operators and the environment.
If you are in the market for an Industrial Eto Sterilizer or need assistance with adjusting the sterilization parameters of your existing equipment, I encourage you to contact us. Our team of experts has extensive experience in the field of Eto sterilization and can provide you with professional advice and solutions. We are committed to helping you achieve the highest level of sterilization quality and efficiency.
References
- ANSI/AAMI/ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
- Pankhurst, M. J., & Furr, J. R. (1990). Sterilization, disinfection and preservation. Blackwell Scientific Publications.
- Block, S. S. (2001). Disinfection, sterilization, and preservation. Lippincott Williams & Wilkins.