Your requirements are our priority

The sterilization process is based on the following steps:

  1. Design of the recipe: The functionality of the product should be studied as well as if it can be subjected to sterilization processes by ethylene oxide. Factors to consider: temperature that supports the product, humidity that can be applied, product design versus vacuum applied to the chamber, vacuum speed and aeration time.
  2. Recipe validation: In compliance with UNE EN-11135, all the necessary tests are carried out in order to obtain a satisfactory validation.
  3. Routine process: Once the corresponding organisms give their approval, the production of sterilization cycles can be started. After the sterilization process, the product must be submitted to the aeration time necessary for the absolute desorption of residual ethylene oxide that may remain. After the aeration time established in the validation, the product is ready for commercialization.
  4. Revalidation of the recipe: In compliance with the regulations, the revalidation of the process recipe is carried out annually.
  5. Process improvements: Every so often, the recipes are subjected to study in order to achieve more efficient cycles at a shorter time.

Sterilization by ethylene oxide

We design the optimal sterilization processes taking into account:

  • Customer needs.
  • Product needs
  • Following the current quality standards.
  • Looking for the safest process.
  • Being respectful with the Environment.

Esterilización, S.L. has facilities designed and designed to work with ethylene oxide. They are installations based on the safety of people and the product and respect for the environment that surrounds us.

The entire sterilization process and the operation of the auxiliary equipment is controlled by the PLC. Which is designed with a whole system of warnings and alarms that inform us of any anomaly that may have occurred.
The PLC controls both the chambers / sterilization process, as well as the aeration room, the central heating boiler, the scrubber (gas scrubber tower), the nitrogen generation plant.
Contact our qualified personnel to study your product and establish the ideal parameters for the sterilization process.

Validations

In compliance with UNE EN-11135, Esterilización offers all its clients the planning and execution of the necessary validations to comply with their agencies. We have all the necessary control equipment to carry out the necessary tests at any time. We also offer the possibility of managing the necessary microbiological analyzes with certified external laboratories. All our facilities meet the current calibrations to perform the validations any day of the year. We can perform initial validations and revalidations of routine processes.