#FAQ What are the main features of EtO sterilization technology?

Parameters for EtO sterilization technology

What are the main features of EtO sterilization technology? What parameters are critical for its success?

Ethylene Oxide (EtO) as a sterilizing agent can be adopted when high temperatures and steam are not supported by the material to be processed. EtO sterilization is a simple, low-cost technology that has the ability to penetrate porous loads and is compatible with the vast majority of medical instruments, but due to its high toxicity, appropriate precautions must be taken.

This process requires the control of 4 parameters: EtO concentration (normally between 450 and 1200 mg/l), temperature (37°C to 63°C), time of exposure (depending on the cycle used) and relative humidity (from 40% to 80%). To understand the relevance of relative humidity (RH%) on EtO sterilization, it is necessary to know how this process works. The microbicidal activity of EtO is the result of alkylation (a chemical reaction) of proteins, DNA and RNA(1). This alkylation interferes with the normal cellular and reproductive processes, which renders a non-viability of affected microbes. Humidity plays a key role in EtO sterilization as it is a critical factor in alkylation chemical reactions and it is the most complex and difficult factor to determine because it influences the proper gas diffusion. Using RH% levels below the recommended lower limit will difficult the sterilization process, as alkylation reactions and proper gas distribution will NOT take place. On the other hand, when working in high percentages of RH (above the maximum recommended) water can (and will) condensate on the surface of the loads being sterilized. Water condensation on the surface function as a barrier for the EtO, hence the sterilization process will fail where condensation occurs. Therefore, it is mandatory to control the proper sterilization process by means of chemical and biological indicators.

At Terragene we offer different solutions for monitoring EtO sterilization processes, for further information visit:

(1) Shintani, H. (2017). Ethylene oxide gas sterilization of medical devices. Biocontrol science, 22(1), 1-16.

🔎 Did you know that Bionova Auto-Readers do not need preventive maintenance?

Bionova auto-readers do not need preventive maintenance

Bionova® Auto-Reader Incubators, including IC1020FR, IC1020FR LCD, MiniBio and MiniPro, do not require preventive maintenance because the system possess an automatic checking test that informs if the equipment presents a deviation from normal performance. Corrective maintenance will only be needed if the incubator alerts of a malfunction.

Equipment must be used according to the user’s manual. The manual includes: instructions on how to use, warnings, storage and operating temperature, energy source specifications, cleaning instructions.

You can download the User´s Manual of each Auto-Reader in the corresponding section on our website:

#FAQ📢 What is the purpose of making a positive control of a given BI?

What is the purpose of making a positive control of a given BI

We assure the correct performance of our BIs for a specified period of time (2 years normally) if properly handled and stored as our specifications indicates.

Due to random factors there might be unexpected false negative results. For this reason AAMI ST79 recommends always using a BI as a positive control (non-exposed to sterilization process) from the same lot number as the one being used for testing.

Did you know that you can evaluate the efficacy of your automatic endoscope reprocessor?

Automatic endoscope reprocessors efficacy

Endoscopes are extremely complex reusable medical devices. Due to their contact with mucous membranes and human tissues, cleaning and high-level disinfection processes prior to reuse must be carried out in order to avoid pathogen transmission.

Endoscope reprocessing involving automatic washer disinfectors requires minimal user intervention and generates highly reproducible washing cycles. It is therefore essential to control the efficacy of these processes in order to ensure compliance with cleanliness standards.

Terragene® launches Lumenia System. A complete line of challenge devices and tests soil to control flexible endoscopes washing efficiency.

Main advantages:

  1. Different configurations according to the different automatic endoscope reprocessors in the market
  2. Its capsules permit the use of two cleaning indicators, one internal and one external.
  3. Compatible with the automatic system for quality control and traceability Trazanto.

More details in the link below:

2019-nCoV #Coronavirus: what is and how to prevent it


Coronavirus refers to a wide family of viruses some of which affect humans and cause a great variety of illness. 2019-nCoV is a new strain of coronavirus first identified in Wuhan (China) in the year 2019. The symptoms of virus infections range from mild to severe and ocasionally could be fatal. Older people, and those with pre-existing medical conditions are more prone to become severely ill due to Coronavirus infection [1].

2019-nCov can be transmitted from person to person after close contact with an infected patient. The spread is primarily through respiratory droplets generated when a person coughs, sneezes, or through saliva droplets or nose discharge.

Prevention is the first barrier to avoid the spreading of the virus. Washing hands frequently, practice respiratory hygiene, maintain at least 1 meter between individuals, avoid touching eyes, nose and mouth; are effective personal measures. Room disinfection is also an important prevention action and hydrogen peroxide has long been used as a disinfectant against viruses, yeasts and bacterial spores. Assuring a proper disinfection process is thus essential [2-4].

At Terragene® we have developed a family of products to assess the efficiency of airborne & surface disinfection through hydrogen peroxide (H2O2). The line is composed of two different Chemical Indicators (ChemSurf: Aerosol and Vapor) and a Biological Indicator (BioSurf). ChemSurf allows the correct monitoring of all critical parameters of the process: time, temperature and H2O2 concentration. Its special 3D design concedes the possibility to evaluate the disinfection process in surfaces with different spatial dispositions. BioSurf is the first fluorescence-based super rapid biological indicator in the market and is fully compatible with all Bionova® Fluorescence Automatic Readers and Bionova® Traceability Software.

[1] World Health Organization (WHO)
[2] Andersen, B. M., Rasch, M., Hochlin, K., Jensen, F. H., Wismar, P., & Fredriksen, J. E. (2006). Decontamination of rooms, medical equipment and ambulances using an aerosol of hydrogen peroxide disinfectant. Journal of Hospital Infection, 62(2), 149-155.
[3] Pottage, T., Richardson, C., Parks, S., Walker, J. T., & Bennett, A. M. (2010). Evaluation of hydrogen peroxide gaseous disinfection systems to decontaminate viruses. Journal of Hospital Infection, 74(1), 55-61.
[4] Heckert, R. A., Best, M., Jordan, L. T., Dulac, G. C., Eddington, D. L., & Sterritt, W. G. (1997). Efficacy of vaporized hydrogen peroxide against exotic animal viruses. Appl. Environ. Microbiol., 63(10), 3916-3918.

Did you know that you can export the results stored in the #Bionova traceability software?

Export results stored in Bionova traceabililty software

Currently, many healthcare institutions use their own software to record information related to their daily processes. However, these softwares could not be directly connected to the different Bionova® incubators, so the sterilization process within such software remained incomplete.

In order to meet such requirement, Bionova® software incorporates (as of version 3.5) a new module named “Bionova® Exchange”. Such module interfaces between the incubators and the third party software, using a system of XML files to implement the data exchange between both systems. Results are exported at the same time they are being saved within Bionova® software.

For more information, you can download the Software Manual on our website (link below) or you can contact our Product Specialists asking for the Bionova® Exchange Module – Developer’s Manual.

WEB-01 Rev.11 22/05/2018