Autoclaves, washer-disinfectors and low-temperature sterilizers drift over time. We revalidate and requalify them on a scheduled agreement, with traceable certificates your quality system can defend. Delivered across Scandinavia by a named specialist.
Revalidation and requalification on a fixed schedule under ISO 17665, EN 285 and ISO 15883, for the life of every unit.
Sensors and gauges lose accuracy quietly. Scheduled revalidation catches it before a load, an audit, or a patient does.
The pharma boom is absorbing Nordic validation talent. We arrive when the gap is widest.
One agreement covers the equipment and the instruments that prove it still performs.
We map every unit and set a calendar to your accreditation cycle.
Competence records for test personnel, approved annual service, reference and test equipment, water quality, chemical residues, calibration.
Thermometric checks on load, cleaning tests on reference and in-use instruments, post-verification of probes. We bring two sets of measuring equipment, so a unit is only out of service for its own test.
A revalidation report that concludes on the machine's validated state, approved by your quality lead. Repeated annually. Price agreed in advance.
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.
Washing and sterilization specialist with 20+ years across washers, autoclaves and CIP/SIP. Has led layout adaptation and engineering specification for major pharmaceutical manufacturers.
Works to the FSTA national revalidation guidelines for large steam autoclaves and instrument washers, EN 285 and DS/EN ISO 15883.
CQV engineer and environmental monitoring specialist. Served as both Engineering Responsible and Operational Responsible on a major API facility expansion, and writes qualification documentation built to withstand inspection.
IQ, OQ and PQ protocols, contamination control strategy, HVAC requalification.
Project leader with hands-on experience in GMP-regulated pharmaceutical environments. Has led technical packages, supplier coordination and validation activities, driving documentation, change control and cross-functional alignment.
Project management, washing and sterilization, IQ, OQ and PQ, FAT/SAT, change control, GMP.
We deliver every day on some of Europe's most compliance-intensive GMP sites. Proof, not promises.
We do not sell sterilization equipment. Our revalidation answers to your compliance and your quality system, documented to the standard you are held to.
Per-unit price and an annual agreement. Cost visible before work begins.
That belongs to the equipment supplier. We do the periodic revalidation afterward, year after year. It is our whole job, which is why we are good at it.
A 30-minute call, and a one-page revalidation assessment within 48 hours. No cost, no commitment.
Or reach us directly: valideringseksperterne.dk · kca@damgaardgroup.com · +45 30 53 07 93
Book a free assessmentMost 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.
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 signed revalidation report.
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.
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.
Then the rationale must be documented in the department's quality management system on the basis of a risk assessment. Without a full revalidation the machine cannot be declared fully validated with reference to the standard. We help you scope it correctly.
Visits are scheduled around your operating room and sterile supply load and planned in advance, so a unit is only out of service for its own check.
Kildehøjvej 15 A
3460 Birkerød, Denmark
Præstemarksvænge 10E
4000 Roskilde, Denmark
