Cleanroom Production
Controlled manufacturing for Healthcare and High-Tech industries
What this solution offers
SP Meditec, MedicoPack and SP Medical operate ISO 14644-1 Class 7 and 8 cleanrooms totalling 11,000 m² across Denmark, Poland and the USA.
Injection, blow moulding and assembly lines run under validated HVAC with 24/7 particle monitoring. Integrated quality systems provide UDI labelling, full batch traceability and electronic DHRs.
Our cleanrooms support products from swab kits and guidewires to diagnostic housings and semiconductor trays. We offer EO and gamma sterilisation coordination plus bioburden testing.
Key Benefits
- Regulatory compliance – ISO 13485, FDA QSR and EU MDR ready.
- Scalable footprint – modular cleanrooms for ramp-ups.
- End-to-end traceability – electronic DHR and UDI.
- Cross-technology inside – moulding, coating and assembly in-room.
- Global access – identical protocols in EU and USA.