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Ethylene Oxide Sterilization Process and Effect Verification
Date: 2025-09-28Read: 0
Have you ever thought about how to ensure sterility of medical devices that come into direct contact with the human body when you open the packaging of disposable masks and disposable syringes? In the field of disposable medical device manufacturing, product sterility is the "lifeline" that safeguards patient safety. One of the core technologies that supports this defense line is ethylene oxide sterilization.
Ethylene oxide sterilizationWith its unique low-temperature penetration characteristics and controlled sterilization process, the microbial survival probability of the sterilized object is reduced to less than one in a million, while maintaining the integrity of the material, making medical safety commitments truly implemented.
Ethylene oxide destroys microbial proteins and nucleic acids through alkylation, achieving broad-spectrum sterilization.As an efficient low-temperature sterilization method, it has become an ideal choice for sterilizing items that are not resistant to high temperatures and high humidity due to its strong penetrability, non corrosiveness, and wide applicability.
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according to ISO 11135:2014《Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices》 The establishment and modification of sterilization processes must go through strict validation procedures to ensure the reliability of sterilization effectiveness.
As a key tool for verifying sterilization effectiveness, Biological Indicators (BI) provide scientific basis and practical path for confirming the effectiveness of sterilization procedures.
1、 Dual security guarantee of biological indicator and chemical indicator card
We are well aware that biological indicators are not just about "putting them in for sterilization and taking them out for cultivation". It is the sentinel of the entire sterilization validation, and its performance directly determines the accuracy, repeatability, and compliance of the validation results.
Biological indicators require a period of time to confirm the effectiveness of the sterilization process. Chemical indicator cards, as "process monitoring tools," can quickly and intuitively confirm whether the object to be sterilized has undergone specific sterilization conditions through color changes, helping users quickly identify abnormalities and reduce ineffective process losses.
Tailin's sheet and self-contained ethylene oxide sterilization biological indicators, as well as ethylene oxide sterilization chemical indicator cards, assist customers in efficiently completing sterilization process validation from precise verification to rapid identification, ensuring the effectiveness of product sterilization processes.
Realize precise verification
IITailin ethylene oxide sterilization validation related products
Self contained ethylene oxide sterilization biological indicator
Product Name |
Self contained ethylene oxide sterilization biological indicator |
model |
ES6-600 |
Indicating microorganisms |
芽孢杆菌 ATCC 9372 |
Total spore count |
1×10^6~5×10^7cfu/pcs |
packaging |
50 pieces/box |
incubation time |
48h |
result judgment |
After sterilization, the chemical indicator card on the bottle label changes from red to blue, and the culture medium inside changes from blue to yellow, indicating a positive result. If it does not change color, it indicates a negative result |
Scope of Application |
Suitable for monitoring the sterilization effect of ethylene oxide sterilizers |
Product Name |
Ethylene oxide sterilization biological indicator (tablet) |
model |
EP6-600 |
Indicating microorganisms |
芽孢杆菌 ATCC 9372 |
Total spore count |
1×10^6~5×10^7cfu/pcs |
packaging |
300 pieces/pack |
Testing cultivation time |
Inoculate in a test tube containing TSB medium and culture for 7 days, then inoculate in Bacillus subtilis culture medium provided with Tyline and culture for 48 hours |
result judgment |
Inoculate in TSB medium, the medium becomes turbid and positive, and clear becomes negative; Inoculate into the Bacillus subtilis culture medium provided by Tailin. If the culture medium changes from orange red to yellow, it is considered positive, and if it does not change color, it is considered negative |
Scope of Application |
Identification of sterilization effectiveness for ethylene oxide sterilizers |
Product Name |
Bacillus culture medium |
model |
MTSB-2.5 |
packaging |
50 pieces/box |
Storage conditions |
2~8℃ |
Validity period |
1 year |
Scope of Application |
Suitable for inoculation and cultivation of biological indicators made from Bacillus subtilis |
Product Name |
Ethylene oxide chemical indicator card |
packaging |
200 pieces/box |
Storage conditions |
Room temperature, dark, dry |
Product Description |
When the chemical indicator card is exposed to ethylene oxide sterilization environment, the coating part of the indicator card will change from red to blue, and the color change is irreversible. It is only used to identify whether the item has undergone sterilization process and is not used as a basis for determining sterilization qualification |
Scope of Application |
Applicable to the monitoring process of ethylene oxide sterilization |
·according to ISO 11138-2：2017《Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes》 The standard is to select Bacillus atrophaeus ATCC 9372, a strain with strong resistance to ethylene oxide, as the indicator microorganism.
·Provide independent spore count reports (≥ 1 × 10 ⁶ CFU/pcs) for each batch, in compliance with ISO 11138-2：2017《Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes》 Requirements for the inoculation amount of biological indicators in China.
Self contained ethylene oxide sterilization biological indicator:
·Self contained integrated design, including spore carrier and color changing culture medium, without additional transfer steps, reducing pollution risks.
·The unique self-contained design effectively prevents the evaporation of the culture medium (evaporation rate ≤ 10% after 48 hours of cultivation) and maintains a stable environment for microbial growth.
·The special formula of the culture medium contains color developing ingredients, and the positive indicator changes color clearly and can be quickly read after 48 hours.
·Selected bacterial carrier materials are easy to carry out microbial elution and counting operations, ensuring the accuracy and reliability of experimental results.
Ethylene oxide sterilization biological indicator (tablet):
·Selected bacterial carriers for easy verification of spore count.
·Unique primary packaging design for easy inoculation operation.
·Automated equipment production ensures high product consistency and stable output.
·outsideThe layer is medical dialysis paper, allowing ethylene oxide gas to enter and achieve effective sterilization; Simultaneously blocking external bacterial invasion and preventing contamination.
·A stable production process ensures highly consistent spore activity, distribution density, and resistance levels between different batches, reducing validation bias caused by indicator fluctuations and improving data reliability.
·Has good thermal stability and moisture resistance, ensuring reliability in different environments.
The combination of ethylene oxide sterilization and biological indicators provides a scientific and reliable solution for ensuring sterility. Through standardized validation, advanced equipment, and professional services, enterprises can achieve efficient and compliant aseptic management. In the future, with the advancement of technology and the improvement of industry standards, the application of ethylene oxide sterilization and biological indicators will be more extensive, providing solid guarantees for the high-quality development of medical, biological, pharmaceutical and other industries.
All biological indicators provided by Tailin Life Sciences Co., Ltd. can be customized according to different carrier materials, sizes, packaging methods, and spore contents. All products come with a testing report, which includes inspection items such as appearance, total spore count, D value, and microbial purity. All biological indicators are produced in a clean environment and comply with regulations such as ISO 11138 and GB18281, providing reliable assurance for customer sterilization monitoring and validation.