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DAMGAARD SOLUTIONS · Revalidation SERVICE

Revalidation that keeps hospital sterilization compliant.

Autoclaves, washer-disinfectors and low-temperature sterilizers drift over time. We recalibrate and requalify them on a scheduled agreement, with traceable certificates your quality system can defend. Delivered across Scandinavia by a named specialist.

Engineering delivery trusted onEurope's most compliance-intensive GMP sites
The problem

Sterilizers drift. Accreditation does not forgive it.

Regulation requires it

Revalidation and requalification on a fixed schedule under ISO 17665, EN 285 and ISO 15883, for the life of every unit.

Drift is invisible until it fails

Sensors and gauges lose accuracy quietly. Scheduled revalidation catches it before a load, an audit, or a patient does.

Capacity is scarce

The pharma boom is absorbing Nordic validation talent. We arrive when the gap is widest.

Scope

The full recurring compliance package.

One agreement covers the equipment and the instruments that prove it still performs.

Equipment requalification
  • Steam sterilizers (autoclaves, EN 285)
  • Washer-disinfectors (ISO 15883)
  • Low-temperature sterilizers (ISO 14937)
  • Thermometric performance on schedule
Instrument calibration
  • Onboard sensors and gauges
  • Calibrated reference instruments (Ellab/Ebro class)
  • Traceable calibration certificates, every visit
Standards coveredDS/EN 285·ISO 17665·DS/EN ISO 15883·ISO 14937·NIR / SSI
Technician placing thermocouple probes into a hospital sterilizer chamber during recalibration
The agreement

Revalidation as a service, not a one-off.

1
Schedule

Map every unit. Set a calendar to your accreditation cycle.

2
Recalibrate on site

Equipment and instruments. Thermometric mapping. Documented protocols.

3
Certify

Traceable calibration certificates and audit-ready reports. Every unit, every cycle.

4
Renew

Recurs annually. Compliance stays live. Price fixed in advance.

Who delivers it
Morten Winsløw, Senior Recalibration Specialist
Morten Winsløw
Senior Revalidation Specialist

30+ years technical experience and 7+ years hands-on IQ, OQ and PQ on Belimed, Steelco and Miele systems, including fully automated CSSD with robots and AGVs.

Works in Danish, Swedish, Norwegian and English.

Why Damgaard

An established team with no hardware to sell.

Established engineering brand

We deliver on GMP sites at Novo Nordisk, Bavarian Nordic and Fujifilm. Proof, not promises.

Independent of the manufacturer

We do not sell sterilization equipment. Our revalidation answers to your compliance and your quality system, documented to the standard you are held to.

Fixed-price, predictable

Per-unit price and an annual agreement. Cost visible before work begins.

Start here

Book a free assessment.

A 30-minute call, and a one-page revalidation assessment within 48 hours. No cost, no commitment.

Or reach us directly: damgaard-solutions.com · +45 30 53 07 93

Book a free assessment
Questions we hear

Common questions.

How often should hospital sterilizers be revalidated?

Most sites revalidate on a fixed annual cycle, and again after any major service or relocation. We set the interval to your equipment, your standards, and your audit history so nothing drifts between checks.

Which standards do you work to?

ISO 17665 for moist heat sterilization, EN 285 for large steam sterilizers, ISO 15883 for washer-disinfectors, and ISO 14937 for low-temperature methods. Every visit ends with a traceable certificate.

Do you work on all makes of equipment?

Yes. We are independent of the manufacturer and we do not sell sterilization equipment, so our only job on site is to confirm your units perform to specification.

What does a revalidation cover?

Instrument calibration and equipment requalification in one planned visit: sensors and controllers verified against reference standards, cycles confirmed, and results documented for your quality system.

How much downtime should we plan for?

Visits are scheduled around your theatre and sterile supply load and planned in advance, so a unit is only out of service for its own check.