Validation Services Hospitals

Agidens supports hospitals with various validation and qualification services.

Thermal validation of sterilization processes and controlled storage rooms

Agidens Life Sciences has the experience and knowledge to support you in the validation of both thermal processes (e.g. stream sterilisation, dry heat sterilisation, ...) and controlled thermal units (from refrigerators to storage warehouses).

Validation of an autoclave according to ISO 17665 / EN 285
  • Determination of the temperature and pressure profile of the process for worst case loads
  • F0 value determination
  • Check alarm messages
  • Steam quality tests
  • Remedy wet loads

Validation of a washer disinfector according to ISO 15883-2
  • Determination of the temperature profile of the process for worst case loading
  • F0 value determination
  • Measurement of the dosed detergent / disinfectant
  • Check alarm messages
  • Control of adequate cleaning based on cleaning indicators

Validation of a low temperature sterilizer according to ISO 11140
  • Determination of the temperature and pressure profile of the process
  • Check alarm messages
  • Demonstration of H2O2 spread based on indicators
  • Demonstrate sterility based on bio-indicators

Validation of a sealer according to ISO 14937
  • Measurement of seal strength
  • Determination of seal uniformity and conformity

Is the registration of your autoclave done correctly, or must an adjustment be made to your system? We are happy to work out an annual program for you, that allows you to use your systems reliably and in a pragmatic way. If desired, Agidens can also provide you with protocols and test scripts for your microbiological checks.

More about thermal validation

Validation endoscopy departments

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.

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.

More about endoscope validation

Validation for cleanrooms and operating theaters (OK)

Agidens will help you check whether your cleanrooms, production areas and operating rooms meet the International regulations and standards (EU, FDA, ISO) or GAMP. We will gladly work out a programme for you for periodic control or (re)qualification of your cleanrooms.
  • Air volumes
  • Pressure differences
  • Filter integrity
  • Air velocity
  • Particle classification
  • Microbiological sampling
  • Air current patterns: Visualisation and registration
  • Recovery time
  • Temperature
  • Relative humidity
  • Light
  • Sound
More about cleanroom validation

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