Expertise Thermal Validation Validation of low-temperature sterilizers

Validation of low-temperature sterilizers

For the validation of low-temperature sterilizers (LTS or H2O2 sterilizer), our validation experts adhere to the following standards and/or recommendations: NEN-EN-ISO 14937, NEN-EN-ISO 11138, NEN-EN-ISO 11140-1, NEN-EN-ISO 22441.


Not all materials that need to be sterilized are resistant to the high temperatures of thermal sterilization. As an alternative to thermal sterilization, chemical sterilization with hydrogen peroxide (H2O2) is used for these materials.

How is the validation of low-temperature sterilizers carried out?

Identification of the LTS

The programs of the LTS are analyzed through 3 analyses:

  • Monitoring of temperature and pressure during the sterilization cycle using portable sensors.
  • Use of biological indicators for the verification of microbial kill.
  • Placement of chemical indicators in the most difficult-to-reach places to ensure complete dispersion of hydrogen peroxide in the sterilization chamber.

Contact us for more information

Agidens has over 25 years of experience in validation & compliance and is a well-known name in the hospital world. Our clients trust us because of our expertise and ‘no nonsense’ approach, and with reliable service, we are a long-term partner.

Ellen Van Der Plas - Agidens