Monitor the conditions advanced therapies depend on
Continuous monitoring of ultra-low temperature and cryogenic storage, cleanrooms and controlled process areas for biotechnology and cell and gene therapy, with alarms and the secure, audit-ready records a scaling quality system depends on.
Trusted in ultra-low temperature storage, cleanrooms and GxP laboratories across the UK.
Trusted by life sciences teams at
The problem
Advanced therapies raise the stakes on every stored sample
Cell and gene therapy has changed what a monitoring failure costs. In autologous therapies the starting material is a single patient’s cells, so a batch is a batch of one, with no re-order and no repeat. That material moves through cryogenic storage, cleanroom manufacture and controlled process areas, each an environment that has to be held and evidenced, often inside a quality system that is young and scaling fast. The organisations doing this work need monitoring that protects the sample and produces inspection-ready evidence from day one, not something retrofitted after the first audit. Eltek monitors exactly these environments, and the detail sits on the compliance page.
What environmental monitoring do biotech and cell and gene therapy need?
Biotechnology and cell and gene therapy depend on continuous monitoring of ultra-low temperature and cryogenic storage, cleanrooms and controlled process areas, with alarms and secure audit trails. Much of the material is patient-specific and irreplaceable, so monitoring has to protect the sample and evidence the conditions across a young, fast-scaling quality system.
The challenge
What makes monitoring cell and gene therapy so demanding?
A batch of one
In autologous cell and gene therapy the raw material is a specific patient’s cells. There is no second batch and no re-order, so the loss of a cryogenic store is not a stock write-off, it is a treatment that cannot be remade.
A cryogenic chain that cannot break
Cells are held cryogenically through storage and handling, and a slow loss can go unnoticed until the material is needed. The chain has to be monitored continuously, with an alarm that reaches someone in time to move product or intervene.
Cleanrooms under EU GMP Annex 1
Manufacture happens in controlled, classified environments. The temperature, humidity and conditions that support them have to be monitored and recorded, part of the controlled environment that EU GMP Annex 1, revised in 2022, addresses for sterile products.
Data integrity in a scaling organisation
Many CGT and biotech organisations are growing quickly, standing up quality systems as they scale. Monitoring that is audit-ready from the start, with secure, attributable, tamper-evident records, is far easier than retrofitting data integrity after an inspection finding.
The solution
How Eltek monitors a biotech and CGT facility
Four principles: watch cryogenic and ultra-low temperature storage continuously, monitor the cleanrooms and process areas around them, build the record for data integrity from the start, and calibrate against traceable standards, all on one system that scales as you do.
Cryogenic and ULT storage, watched continuously
Wired probes and wireless GenII transmitters monitor ultra-low temperature and cryogenic storage continuously, so a slow loss is seen as it develops and an alarm escalates before irreplaceable material is affected.
Cleanrooms and process areas on the same system
Temperature and humidity across cleanrooms and controlled process areas report into the same platform as your storage, so the whole regulated environment sits in one record rather than several disconnected ones.
Records built for data integrity
Darca Command stores continuous, time-stamped, tamper-evident readings with secure audit trails and role-based access, the electronic-record controls MHRA data integrity and EU GMP Annex 11 anticipate, ready for inspection from the start.
Mapping, validation and calibration support
Temperature mapping of stores, chambers and cleanrooms, with UKAS-traceable calibration certificates and mapping reports that support your IQ, OQ and PQ documentation as the facility qualifies.
One system that scales with you
The same connected system extends with repeaters and added sensors as the facility grows, so monitoring keeps pace with a scaling operation rather than being rebuilt each time.
Standards and guidance
Which standards apply to cell and gene therapy environmental monitoring?
Advanced therapy medicinal products (ATMPs), which include most cell and gene therapies, are manufactured under EU GMP as retained and enforced by the MHRA in the UK. EU GMP Annex 1, revised in 2022, addresses the manufacture of sterile products and the controlled, classified environments that support them, and EU GMP Annex 11 (Computerised Systems) governs the computerised systems that hold GMP data, including the audit trails a monitoring system produces.
Where qualification and validation are concerned, EU GMP Annex 15 frames the IQ, OQ and PQ lifecycle for equipment and facilities, and the MHRA “GXP” Data Integrity Guidance and Definitions (March 2018) runs through all of it, expecting the data behind a GxP decision to be complete, consistent and accurate across its lifecycle, the principles summarised as ALCOA+.
For a fast-scaling organisation, the practical point is that these controls are easier to build in than to bolt on. A monitoring system that captures secure, attributable, tamper-evident records from the first freezer supports data integrity as the quality system matures, rather than becoming an inspection finding later. Eltek supplies that evidence and the controls behind it; validation of the system in its intended use stays the organisation’s responsibility. The compliance page sets out each framework in turn.
The platform
The Darca Suite
One connected suite, wired and wireless, for cryogenic storage, cleanrooms and controlled process areas, that scales as you do.
Darca Collect
Wired probes and wireless GenII transmitters monitor ultra-low temperature and cryogenic storage, cleanrooms and controlled process areas, calibrated against UKAS-traceable standards so every reading is defensible.
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Darca Connect
The SRV450 hub relays the network securely and SMS450 escalates an out-of-tolerance excursion by grouped SMS and email, including out of hours, before irreplaceable material is affected.
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Darca Command
Darca Command holds continuous, time-stamped, tamper-evident records with secure audit trails, role-based access and scheduled reporting, built for GxP, EU GMP Annex 11 and MHRA data-integrity expectations.
ExploreProven in regulated science
Ultra-low temperature storage, watched continuously, with the evidence an audit expects
Eltek has monitored ultra-low temperature and cryogenic storage in the UK for years, including validated mapping and continuous monitoring of biobank storage for research-governance traceability. The same GenII loggers, the cloud-connected Darca Suite and Cyber Essentials certification give a biotech or cell and gene therapy team continuous visibility of cryogenic storage and cleanrooms, secure audit-trailed records and UKAS-traceable calibration: the controls and the evidence that support GMP compliance as the facility scales, without ever claiming to confer it.
- EU GMP Annex 1
- EU GMP Annex 11
- MHRA data integrity
- UKAS-traceable calibration
Speak to an Eltek expert
Tell us about your cryogenic storage, cleanrooms and process areas, and our UK engineers will design monitoring that protects the material and produces the data-integrity evidence your quality system needs.
Related reading
Life Sciences compliance
MHRA data integrity, EU GMP Annex 11 and GAMP 5, and exactly what Eltek supplies versus what stays yours.
Read moreEquipment we monitor
Ultra-low temperature and cryogenic storage, cleanrooms and process areas, and how each is monitored.
Read moreThe Darca Suite
Collect, Connect and Command: the sensing, the alarms and the audit-trailed software that scale with a facility.
Read moreMore in Life Sciences
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GMP sites, cleanrooms, cold rooms and stability storage. Continuous monitoring and audit-ready records for the environments a regulated batch depends on.
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Cold Chain Monitoring
Cold rooms, refrigerators, freezers and GDP warehouses. Continuous monitoring, mapping before use and audit-ready records that prove the cold chain held.
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IVF & Fertility Clinics
Incubators, cryogenic storage and the embryology lab. Continuous monitoring and instant alarms for samples that can never be replaced.
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Clinical & Diagnostic Laboratories
NHS pathology, diagnostics and contract testing. Continuous monitoring of fridges, freezers and sample stores, with a record for UKAS and ISO 15189.
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Universities & Research
University biobanks, research estates and core facilities. Continuous monitoring of ULT freezers and cryogenic storage, with alarms and a record for research governance.
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Equipment we monitor
ULT freezers, refrigerators, incubators, stability chambers, cold rooms, cryogenic storage, cleanrooms and GDP warehouses. One compact answer per equipment type.
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Temperature mapping guide
What a mapping study proves, how to run one, sensor placement principles, duration, UK compliance expectations, and the calibrated equipment your results depend on.
ExploreFrequently asked questions
Why is environmental monitoring so critical in cell and gene therapy?
Because in autologous cell and gene therapy the starting material is a single patient’s cells, so the batch is a batch of one, with no re-order and no repeat. That material passes through cryogenic storage, cleanroom manufacture and controlled process areas, each of which has to be held within tight conditions and evidenced for the record. Continuous monitoring protects the material by catching a drift as it happens and escalating an alarm in time to act, and it produces the secure, tamper-evident record a quality system and an inspector rely on. Eltek monitors these environments on one connected system.
How does Eltek support EU GMP Annex 1 cleanroom monitoring?
EU GMP Annex 1, revised in 2022, addresses the manufacture of sterile products and the controlled, classified environments that support them. Eltek monitors the temperature and humidity of cleanrooms and controlled process areas continuously, feeding the same connected system as your storage, so the whole regulated environment sits in one time-stamped, audit-trailed record. Eltek supplies the monitoring evidence and the controls behind it; the classification, validation and control of the cleanroom in its intended use remain the organisation’s responsibility.
Can monitoring keep up as a biotech facility scales?
Yes. The same connected Darca Suite extends with repeaters and additional wired or wireless sensors as a facility grows, so monitoring keeps pace with new freezers, cleanrooms and process areas rather than being rebuilt each time. Building audit-ready, data-integrity-compliant monitoring in from the first freezer is far easier than retrofitting it after an inspection, which matters for the many CGT and biotech organisations standing up quality systems as they scale.
Does Eltek monitoring make our ATMP facility compliant?
No monitoring product makes a facility compliant on its own, and any supplier who claims otherwise should be treated with caution. Compliance depends on your validation, your procedures and the controls around them. What Eltek provides are the underlying controls regulators ask for: secure, time-stamped, tamper-evident records with full audit trails, role-based access and scheduled reporting, backed by UKAS-traceable calibration, across cryogenic storage, cleanrooms and process areas. Eltek supplies the evidence and the controls that support your compliance; validation and process remain yours.