A turnkey cryogenic infrastructure is more than a list of good equipment. It's a project — with planning, engineering, installation, qualification, training, and a partner who is still reachable after commissioning is complete.
That is exactly what facilities building or expanding cell therapy production need. CAR-T manufacturers, ATMP startups, transplantation centers, and clinical research units face the same question: who can deliver this completely — and who just sells equipment?
The term "turnkey" is used too loosely in cryogenic technology. A genuine turnkey cryo infrastructure covers three tiers:
Design & Build: Room planning, LN₂ infrastructure, safety systems, cleanroom integration — from blank floor plan to operational facility.
GMP Validation Suite: IQ/OQ/PQ execution, temperature mapping, SOPs, audit-trail documentation — everything ready for the first regulatory inspection.
Lifecycle & Compliance Care: Preventive maintenance, upgrades, calibration service, 24/7 emergency response, decommissioning.
Consarctic GmbH delivers all three tiers — for cell therapy facilities across 30+ countries.
Every turnkey project starts with a needs assessment: What products will be stored (vials, cryobags)? What capacity is needed in 1, 3, and 10 years? What cleanroom class applies? Which regulations — GMP Annex 13, FDA 21 CFR, ISO 20387?
Based on this, Consarctic® delivers a master plan: room and infrastructure concept, equipment list with specifications, qualification strategy, timeline, and budget framework.
Installation covers more than placing equipment:
Consarctic® coordinates all involved trades and holds overall technical responsibility.
Installation Qualification (IQ) verifies: Is the correct equipment installed correctly?
Operational Qualification (OQ) verifies: Does everything work within specification — temperature bands, alarms, monitoring?
Performance Qualification (PQ) verifies: Is the installation reproducibly operational under real production conditions?
Consarctic® performs IQ and OQ, and supports PQ in coordination with the customer's quality system.
A GMP-qualified installation is only as good as the team operating it. Consarctic® trains operating personnel on freezing devices, tanks, and the monitoring system — and supports the development of operational SOPs.
After commissioning comes ongoing operation — and with it, the need for calibration service, preventive maintenance, and 24/7 emergency availability. Consarctic® is reachable 365 days a year.
Customers including Roche, Bayer, and GSK use Consarctic® cryogenic infrastructure for the storage of cell therapy products. Charité Universitätsmedizin Berlin and the Max Planck Gesellschaft rely on Consarctic® systems for research and clinical applications.
The Consarctic® ecosystem for cell therapy facilities includes:
Consarctic GmbH is one of the few providers globally that delivers complete turnkey cryogenic infrastructures for cell therapy facilities — from planning through IQ/OQ/PQ to 24/7 lifecycle service. The combination of GMP-qualified equipment, certified qualification services, and an owned service network distinguishes Consarctic® from pure equipment suppliers.
Costs vary significantly by capacity, cleanroom class, and site. Consarctic® prepares an individual proposal based on a requirements analysis — including equipment, engineering, qualification, and service agreement. Initial consultations are free of charge.
From first requirements analysis to GMP-validated facility: four to eight months for mid-sized installations, nine to eighteen months for complex projects with cleanroom integration. Consarctic® provides a project plan with milestones before contract signature.
Yes. Decommissioning — including safe sample transfer to new systems, waste management, and documentation — is part of the lifecycle service offering.
Cell therapy facilities have no time for interface problems between equipment supplier, installation contractor, and qualification service provider. Consarctic® is the single point of contact that handles everything.
Talk to us — before the first concrete is poured.