XiltriX
Modern cryogenic storage laboratory with monitored vessels and ultra-low temperature freezers
SoHO & Human Biological Material

SoHO monitoring built for what cannot be replaced.

Blood, tissues, cells and reproductive material depend on controlled conditions throughout their lifecycle. XiltriX continuously monitors the critical environments and equipment around them, so deviations do not go unnoticed.

The material at the centre

When the material is irreplaceable, monitoring cannot be an afterthought.

Substances of Human Origin, or SoHO, include human blood, tissues, cells and reproductive material intended for human application. Collection, processing, testing, storage and distribution can all depend on tightly controlled equipment and environmental conditions.

Whether material or an activity falls within the Regulation depends on its specific context. XiltriX supports operational control; it does not determine legal classification.

Blood and plasma
Tissues and cells
Gametes and embryos
Stem cells
Human milk
Microbiota and other SoHO
The European context

SoHO 2027: a higher bar for safety, quality and resilience.

Regulation (EU) 2024/1938 strengthens the European framework for substances of human origin, with greater attention to donor and recipient protection, vigilance, continuity of supply and crisis preparedness.

The Regulation generally applies from 7 August 2027.
The first functions of the official EU SoHO Platform were released on 15 September 2026. This is a separate milestone from the Regulation's general application date.

XiltriX helps organisations maintain continuous control over the operational conditions that support quality, safety and resilience. It is not a legal compliance certification.

Read the official European Commission overview
Operational control

What does SoHO resilience look like in practice?

Three questions connect regulatory intent to what happens around a freezer, vessel, incubator or controlled room every day.

01 · Detect

Can you continuously detect changes in critical conditions?

Monitor temperature, humidity, gases, power, doors, equipment status and other critical parameters independently from the equipment itself.

02 · Respond

Will the right person know when something changes?

Automatic escalation follows the customer's own on-call list until an alert is acknowledged, rather than creating another isolated equipment alarm.

03 · Prove

Can you reconstruct what happened?

Continuous data, event history, alarm records and documented responses create a traceable operational record.

XiltriX Resilience

One system, three layers around critical material.

Infrastructure, Intelligence and Care work together. They are not separate products or isolated services.

Infrastructure

Monitor what matters.

Purpose-built monitoring stations, sensors and resilient connectivity create an independent view around critical assets and rooms.

  • Refrigerators and freezers
  • Ultra-low and cryogenic storage
  • Incubators and gases
  • Temperature and humidity
  • Power, doors and room conditions
Intelligence

Understand what is happening.

Continuous data becomes a clear operational picture, with automatic escalation and evidence that can be reviewed later.

  • Real-time monitoring
  • Alarm management and escalation
  • Event and audit history
  • Reporting and operational insight
  • Integration through a public REST API
Care

Keep the monitoring chain reliable.

Implementation, calibration, maintenance and operational reviews support the system throughout its working life.

  • Installation and commissioning
  • Validation support and calibration
  • Maintenance and battery replacement
  • Annual operational review
  • 24/7 technical support for the monitoring system

XiltriX detects, alerts and escalates through the customer's configured contacts. The customer decides who receives an alert and remains responsible for the physical response. XiltriX is available 24/7 when the monitoring system itself has a technical issue.

Across regulated environments

Where SoHO resilience can matter.

SoHO is not a single industry. It can overlap with several clinical, laboratory, storage and manufacturing environments.

Blood and tissue banks

Continuous visibility around refrigerators, plasma freezers, platelet storage and controlled rooms.

Cell and stem-cell banks

Traceable conditions around sensitive cell material and long-term storage.

Biobanking and cryobanking

Independent monitoring around collections that may be impossible to recollect.

IVF and ART

Controlled conditions around embryos, gametes, incubators and cryogenic storage.

Hospitals

One monitoring picture across blood banks, tissue facilities, laboratories and pharmacies.

Cell and gene therapy

Evidence across controlled rooms, incubation, processing and cryogenic storage.

Clinical and academic research

Reliable records around human material used in relevant research and clinical activities.

Not every activity or material in these environments is necessarily classified as SoHO. Classification depends on the applicable activity and legal context.

From signal to insight

Monitoring is only the beginning.

Operational resilience comes from the complete chain around a measurement, not from a sensor reading alone.

Nothing left to chance.

  1. 1Condition changes
  2. 2Independent detection
  3. 3Intelligent alert
  4. 4Customer escalation
  5. 5Human response
  6. 6Event documented
  7. 7Operational insight
A practical next step

Protect what cannot be replaced.

Discuss how greater resilience can be built into the environments that protect human biological material.

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