Sterilisation Validation for Cleaning and Sterilisation Processes

Validation of endoscopes and dry cabinets

In order to meet all of the requirements from the JCI or NIAZ-accreditation, it is required to be able to demonstrate that all hospital devices, that are part of a disinfection or sterilization process, work properly. Since the devices in the department endoscopy are entitled to a disinfected scoop, they should be validated. Validation ensures correctly cleaned and disinfected endoscopes. In addition, it assures that the scopes can be dried and stored.

A specific validation program is necessary to determine the efficiency of these devices. Endoscopes differ, after all, both in use and composition of traditional instruments; a pure parametric validation is not sufficient to guarantee cleaning and disinfection. Microbiological tests are a necessity. Agidens provides a customized solution based on the current guidelines.

 

Validation of a scopes disinfector in accordance with ISO 15883-4

  • Determination of the temperature and pressure profile of the process in the scoop
  • Measurement of the dosed detergent / disinfectant
  • Control alarms plugged / unplugged channels
  • Control alarm at simulated ingress
  • Verification of proper cleaning in an endoscope, on the basis of cleaning indicators, placed in a surrogate endoscope
  • Verification of adequate disinfection in an endoscope, on the basis of bio-indicators, infected with E. faecium, placed in a surrogate endoscope
  • Demonstrate proper self-disinfection of the unit (chemical / thermal)


Validation of a dry cabinet in accordance with ISO 16442

  • Measurement of number of colony forming units on the walls of the dryer
  • Measurement of the particle air in the dryer, at 0.5 and 5.0 microns. By performing both measurements, you are certain that there is no possibility of contamination.
  • Control residual moisture in the scopes that have undergone a drying process
  • Control alarm disconnected channels
  • Determination of the temperature and pressure profile during the drying cycle
 

The validation of your scopes disinfector and drying and storage closet gives you insight into what is effectively happening in the unit. In addition, our validation report is your documented evidence and added value in audits.

Why partner up with Agidens for endoscope validation?

  • Agidens Life Sciences has over 20 years of experience in validation and compliance and is known in the hospital world.
  • Our customers trust us because of our knowledge, no-nonsense approach and flexibility.
  • Each project requires a specific approach. That's why validation and qualification projects are always tailored to the customer.
  • A reliable service ensures long-term partnerships in various sectors

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