VALIDATION
From sterile wash to trendsetter in asepsis
Validation is part of comprehensive quality management and patient safety. The Act on Medical Devices requires regular verification of device performance — validation tests, ensures and demonstrates the sterilising end result of the equipment.
Steam sterilisation
We measure the temperature distribution of the autoclave and the penetration of steam into the load — even in the most difficult-to-sterilise packaging.
Washing and disinfection
We verify the washing results and disinfection A0 values through measurements — the instrument is also clean in places where the eye cannot see.
Sealing and packaging
We test the temperature of the sealing device and the strength of the seal — the packaging maintains sterility during storage and transport.
Water treatment
We monitor the quality of process water from washing to sterilisation — poor water quality leaves residues and shortens the lifespan of instruments.
Endoscope hygiene
We validate washer-disinfectors and drying cabinets — the channels of flexible endoscopes are the most demanding area for hygiene.
This is how the validation progresses
See how the five-step process works in practice.
Validation process · 5 steps
We validate all devices — regardless of brand
Autoclaves
Washer-disinfectors
Endoscope cleaning process
Jointing equipment
Environmental chambers and cabinets
Hot Air Sterilisers
Filling machines
Packaging and inspection machines
01
Design
The validation load is created in cooperation with the customer.
02
Measurements
Temperatures and pressures are measured in packages, instruments, loading methods and equipment — in the customer's individual operating environment.
03
Documentation
The clear report details the actions taken and the measurement results — and serves as a checklist that is easy to return to.
04
Approval
The report will be reviewed together, highlighting potential areas for development. The client approves the report.
Dairy Queen
Documentation review
An assessment carried out in connection with the acquisition or commissioning of equipment to ensure that the equipment is suitable for user requirements and regulatory standards.
IQ
Installation check
Recording of basic details, comparing the installation to drawings and electrical schematics, piping leak tightness, and calibration of critical measuring devices.
OQ
Operational testing
Power failure, interruption, interlock and alarm tests, chamber leak tests, steam penetration tests, and empty chamber temperature distribution runs.
PQ
Performance testing
The annual validation uses the loads that are most difficult to sterilise. Within the packaging, the required sterilisation conditions (e.g. 134 °C / 3 min) must be achieved — repeatability is verified with three measurements.
ISO 15883 (Washer-disinfectors)
Standard: ISO 15883 – Quality assurance for washer-disinfector processes
What does it mean?
ISO 15883 is an international series of standards that sets strict performance requirements for washer-disinfectors. It ensures that the equipment cleans and disinfects medical instruments reproducibly and safely before they are further processed or used.
Why is it important to you?
In sterile services, simply starting a machine is not enough – you must be able to prove that the device is functioning as intended. Validation in accordance with the ISO 15883 standard is a regulatory requirement that ensures patient safety. It provides documented evidence that the amount of soil on the instrument has been reduced to the required level and that the instruments are clean.
The role of IndiCal:
We carry out validations (IQ, OQ and PQ) of washer-disinfectors strictly in accordance with the ISO 15883 standard. We use calibrated measuring instruments and our expertise to ensure that your processes meet all quality requirements – regardless of the brand and model of the device.
FAQ
Is your question not on the list? Contact us — we will reply by the next working day at the latest.
What is the difference between IQ, OQ, and PQ phases?
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Why are the empty chamber runs performed at a temperature of 121 °C, even though this temperature is not used in our sterilisation programmes?
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Why must the load be completely dry inside and outside the packaging during validation, even though the EN 17665 standard allows 0.2% moisture in a metal load?
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Do you perform validations all over Finland?
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How often should validations be carried out for sterile services equipment?
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Why aren't all decontamination equipment validated?
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Is validation disrupting the daily routine of instrument maintenance?
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What does the validation report contain?
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List your devices — you will receive an offer by the next working day at the latest.