Cell and gene therapy products are often made for one patient, in small batches, on tight schedules. Material moves from collection to cleanroom processing, incubation, cryopreservation and shipment. A deviation at any step can cost a treatment, not just a batch.
What these sites typically monitor
Cleanrooms with differential pressure and particle counts, CO₂ and O₂ incubators, refrigerators, freezers, ULT freezers, LN₂ storage and controlled-rate freezing areas, room temperature and humidity, and O₂ safety levels.
What buyers look for
An environmental monitoring system delivered with GxP validation and calibration, alarm management that fits time-critical work, and evidence that supports EU GMP (including Annex 1 for aseptic processing) and ATMP-specific guidance.
Why an integrated view matters
In ATMP workflows the same event can affect several assets at once. A power dip can hit incubators, freezers and the cleanroom air handling together. Seeing these in one system, with one timeline, makes investigation faster and more convincing.
What XiltriX brings
XiltriX combines expertise in cryogenic infrastructure, cleanroom monitoring, incubators, freezers and LN₂ storage with validated software and smart alarm management. Instead of simply collecting data, it helps teams prove control, prevent deviations, support GMP compliance and respond before product integrity is at risk.
How XiltriX Resilience fits
XiltriX Resilience is an Operational Resilience System built on three layers:
- Infrastructure: independent sensors and monitoring stations with battery support, resilient connectivity and local data buffering, so a power or network interruption does not create a gap in the record.
- Intelligence: validated software that turns measurements into alarms, escalation, trends, reports and audit-ready evidence.
- Care: installation, validation, calibration, preventive maintenance and 24/7 technical support for the monitoring system, delivered by one partner that is ISO 9001 and ISO 27001 certified.
Who does what when an alarm fires
XiltriX Intelligence applies the limits, delays and escalation sequence agreed with the customer, and keeps escalating through the customer's contacts until someone acknowledges. The customer's own team assesses the situation and carries out the physical response.
XiltriX does not respond to the customer's alarms. XiltriX Care provides 24/7 technical support when the monitoring system itself has a problem.