Follow us on
Medical and surgical instruments, especially single-use devices, must be safe to use since they are in direct contact with patients. One of the most common methods to ensure that these instruments are free from harmful microorganisms is ethylene oxide (EO) sterilization. It has become a cornerstone in the healthcare industry for its effectiveness in sterilizing delicate and complex instruments without causing damage.
In this blog post, we’ll explore the EO sterilization process for single-use instruments and the certifications needed to ensure that the process is performed correctly and safely. We’ll also highlight how Beauty Teck, a trusted name in the industry, adheres to these rigorous standards.
Ethylene oxide (EO) is a colorless flammable gas used as a sterilant for medical devices.This gas works by disrupting the DNA of microorganisms, preventing them from reproducing and ensuring that the instruments are free from harmful pathogens.
Chemical Formula | EO Composition | Shelf Life | Storage Temperature | Critical Pressure |
C2H4O | 20%EO & 80% carbon | 6 months | Less than 50 deg | 71 bar |
This usually occurs in a sterilization chamber, where first, the air is evacuated by vacuum sealing the instruments. The EO gas is then injected into the chamber with a particular concentration and temperature for a particular duration. The exposure is followed by aeration, which evacuates all remaining EO gas, so instruments remain safe for use.
Bioburden Limit refers to the maximum acceptable number of viable microorganisms present on a medical device or product before it undergoes sterilization. It is an essential metric used in the validation and control of sterilization processes, as it helps determine the required sterilization conditions and ensures that the sterilization method used will be effective in reducing the microbial load to a safe level. Bioburden limits have been established at around 10 to 100 CFU per device, depending upon the type of device and use. Devices greater than these are usually cleaned extra or validated so that they become EO-compatible for sterilization.
Biological indicators (BIs) are a critical component in confirming the effectiveness of a sterilization process. These indicators contain a known quantity of microorganisms (usually bacterial spores) that are highly resistant to the sterilization method being used. To verify the sterilization process, biological indicators (BIs) are used. These indicators contain resistant bacterial spores that are exposed to the sterilization process alongside the instruments. BIs are often placed inside the packaging pouch along with the instruments to test the sterilization of both the devices and the packaging itself. If the spores in the BI are killed, it confirms that the sterilization was effective, ensuring that both the instruments and their packaging are safe for use.
BIs provide an additional layer of verification to guarantee that no viable microorganisms remain after EO treatment.
For best effects, Beauty Teck collaborates with MSS, a critical subcontractor that specializes in EO sterilization. MSS is SGS ISO 13485:2016 certified and, therefore assures that it upholds the very highest standards in quality management related to medical device sterilization. It ensures that sterilization procedures that Beauty Teck's single-use instruments undergo follow the most stringent industry norms, thus bringing an added measure of confidence regarding the safety and efficacy of the sterilization process.
The sterilization validation involves three key cycles —Fractional, Half, and Full Cycles — to ensure the process meets the stringent standards outlined in ISO 11135:2014. Each cycle tests specific conditions to verify the parameters necessary for effective sterilization.
The Fractional Cycle focuses on establishing the minimum exposure parameters necessary to achieve sterilization without compromising material integrity. Below are the key input parameters used during the fractional validation process:
Process Parameters | Input Values |
Pre-conditioning Temperature | 20 - 45 °C |
Conditioning Humidity | 65% ± 15% |
Pre-conditioning Time | 1 - 10 hours |
Conditioning Dwell | 15 ± 1 mins |
Loading Temperature | 30 - 45 °C |
Conditioning Time | 1 - 3 hours |
Conditioning Temperature | 55 °C ± 3 °C |
EO Volitizer Temperature | 65 °C ± 3 °C |
Gas Injection Time | 6 - 12 mins |
EO Injection Pressure Limit | 60 ± 2 kPa |
Sterilization Chamber Temperature | 55 °C ± 3 °C |
Air Removal Time | 45 ± 5 mins |
Total Aeration Time | 1 hour |
Total Fractional Cycle Time | 3 - 4 hours |
Half and Full Cycles
The Half Cycle involves validating the sterilization process at half the EO exposure time of the Full Cycle, while the Full Cycle tests the complete process. Both cycles follow similar input parameters as the Fractional Cycle but adjust exposure times accordingly to validate the robustness of the sterilization process.
The packaging of sterilized instruments is just as important as the sterilization process itself. Beauty Teck uses PMS sterile packs, which is designed specifically for medical instruments. This packaging is equipped with three indicators, ensuring that all sterilization parameters are met. These indicators provide a clear visual confirmation of the sterilization status, offering both the manufacturer and the healthcare provider peace of mind that the instruments are properly sterilized and safe for use.
Beauty Teck, a leader in the medical device sector, has earned the necessary certifications to perform EO sterilization on its range of single-use instruments.
Key Certifications at Beauty Teck:
ISO 11135-1:2014: Requirements for development, validation, and routine control of a sterilization process for medical devices.
· ISO 11737-1: Determination of a population of microorganisms on products.
· ISO 11737-2: Tests of sterility performed in the validation of a sterilization process.
· ISO 11138-1: Sterilization of health care products — Biological indicators — Part 1: General requirements.
· ISO 11138-2: Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes.
· ISO 11607-1: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems, and packaging systems.
ISO 13485:2016 Certification: For rigorous quality control measures across all stages of production, including sterilization.
EO sterilization is a process critical to ensuring single-use medical instruments are safe, effective, and free from harmful pathogens. Beauty Teck ensures that products are maintained within strict bio burden limits and verified for sterilization through biological indicators placed within the packaging pouch. MSS, a certified sub-contractor for sterilization, will be Beauty Teck's partner in ensuring its products meet the highest safety and quality standards. In addition, the use of PMS Sterile Packaging transparent packaging with three sterilization indicators ensures that the instruments and their packaging are intact and sterile. These companies ensure that their instruments are sterilized properly and meet global standards, thereby protecting patient health and enhancing the quality of healthcare in general.
If you want a detailed document about our sterilization cleanroom, feel free to contact us at ecommerce@beautyteck.com
Beauty Teck: "Clean Instruments, Healthy Outcomes"
Written by: Beauty Teck
Thank you for reading! Feel free to Ask or review anything related to the topic on Quora, Blogger or Medium
08:30 – 13:00 | 13:30 – 17:00
08:30 – 13:30 | 14:30 – 17:30
08:30 – 13:00 | 13:30 – 17:00
Closed