Production in cleanroom ISO class 8

ISO Class 8 per ISO 14644-1:2015. The classification covers two fully validated cleanrooms used for assembly, inspection, printing, and packaging of medical components, plus the clean zones around the injection moulding cells. Carmo measures airborne particles at the 0.5, 1.0, and 5.0 µm size bands as the standard requires.

Both. ISO 14644-1 explicitly permits classification of full cleanrooms AND clean zones; Carmo uses both — two physical cleanroom halls for downstream assembly and packaging, plus classified clean zones around the injection moulding machines themselves. Both operate under Carmo's certified ISO 13485 QMS and share the same routine monitoring discipline.

Both. The full cleanrooms are used for assembly, inspection, printing, and packaging of medical components; the moulding clean zones cover the injection-moulding step. A medical component can move from raw material through final packaged form without leaving a classified environment — a meaningful regulatory benefit for medical-OEM supplier qualification.

Yes. All cleanroom production happens at Carmo's single integrated site in Espergærde, Denmark — the same site that handles design, development, tooling, moulding, automation, and additive manufacturing. No cleanroom work is subcontracted or located outside Denmark.

Medical-device OEMs primarily, across medical bags (urine, infusion, nutrition), identification bracelets, immobilisation equipment, urology, diagnostics, and surgical devices. Many customers have run the same components on the same registered device through Carmo's cleanroom for 20 to 30 years — and the cleanroom is a load-bearing part of why those relationships last.

Yes — on a case-by-case basis. Some technical applications require cleanroom-grade contamination control: components destined for sealed assemblies, optical or sensor applications, or high-purity industrial uses. Whether a non-medical application runs through the cleanroom is settled during scoping rather than as a default.

Component-level traceability is part of the standard documentation set: batch records, in-process controls, material-lot traceability, and post-production inspection data are all maintained under Carmo's certified ISO 13485 QMS. The documentation depth is sized for medical-OEM supplier qualification and customer audit — not incidental record-keeping.

Routine internal particle-count monitoring at the standard size bands (0.5 / 1.0 / 5.0 µm) is complemented by recurring external verification by a specialist. Action limits are set below acceptance limits, so deviations are surfaced and corrected before they reach a classification breach. Bioburden monitoring is performed as a separate environmental control — not part of the ISO 14644 classification.

Carmo has operated cleanroom production for the medical-device industry for decades. The 2018 site expansion added approximately 1,000 m² of additional production space and 200 m² of additional ISO Class 8 cleanroom capacity — roughly doubling the production footprint. Carmo's QMS has been continuously ISO 13485-certified since 2013.