Protect samples and results across the diagnostic lab
Continuous monitoring of the refrigerators, freezers and sample stores that hold specimens and reagents across a clinical or diagnostic laboratory, with alarms and a continuous record that evidences the conditions behind every result.
Trusted in clinical, pathology and diagnostic laboratories across the UK.
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The problem
In a diagnostic lab, storage is part of the result
A clinical or diagnostic laboratory lives on the integrity of what it stores. Patient specimens, control materials and reagents all depend on being kept within range, and a fridge or freezer that drifts unnoticed can quietly compromise a result long before anyone questions it. These labs run at pace, often with dozens of refrigerators and freezers across pathology disciplines, and under the scrutiny of UKAS accreditation to ISO 15189. What they need is not another standalone datalogger per fridge, but one continuous record that covers every store and stands up when an assessor asks how conditions were controlled. Eltek monitors exactly this, across the whole estate of equipment.
How do clinical and diagnostic laboratories monitor sample and reagent storage?
Clinical and diagnostic laboratories monitor the refrigerators, freezers and sample stores that hold specimens and reagents, continuously and with alarms, so a result is never compromised by an unnoticed excursion. Under ISO 15189, the standard UKAS accredits medical laboratories against, environmental conditions that affect results are controlled, and a continuous record evidences that control.
The challenge
What makes monitoring a clinical laboratory so demanding?
Storage that affects the result
Specimens, control materials and reagents all have storage conditions that affect the validity of a test. A refrigerator or freezer that drifts out of range can compromise a result, and the consequence is a clinical decision made on data that should not have been trusted.
Many fridges and freezers, at pace
A pathology service can run dozens of refrigerators and freezers across haematology, biochemistry, microbiology and histology. Checking each by hand is a workload that competes with the actual testing, and the one that drifts is the one nobody had time to check.
Accreditation that turns on evidence
UKAS accredits medical laboratories to ISO 15189, and an assessment asks how the conditions that affect results are controlled and evidenced. A continuous, timestamped record answers that far better than a clipboard of twice-daily manual readings with inevitable gaps.
Out-of-hours and unattended risk
Samples and reagents sit in storage overnight and at weekends when the lab is quiet. Without an alarm that leaves the building, a failure that starts on a Friday evening is only discovered when staff return, long after the stored material was lost.
The solution
How Eltek monitors a clinical and diagnostic laboratory
Four principles: monitor every store continuously into one record, escalate a problem out of hours, evidence the conditions that affect results for accreditation, and calibrate against traceable standards so the record is trusted.
Every fridge, freezer and sample store on one system
Wireless GenII transmitters and wired probes monitor refrigerators, freezers and sample stores continuously across the lab, so an estate of units reports into one platform rather than a datalogger per fridge.
Alarms that escalate out of hours
SMS450 turns a threshold breach into grouped SMS and email alerts that escalate to the right person, including nights and weekends, so a failing store is caught while specimens and reagents can still be saved.
A continuous record for accreditation
Darca Command holds a continuous, time-stamped record of every monitored store, with trends and scheduled reports, so a lab can evidence to a UKAS assessor how the conditions affecting results were controlled, over any period.
Reduced manual checks
Continuous monitoring removes the twice-daily paper round, freeing biomedical scientists from clipboard temperature checks and closing the gaps those rounds inevitably leave between them.
Calibration you can defend
Sensors carry UKAS-traceable calibration, so a reading means what it says against a national standard when an assessor or a clinical query turns on it.
Standards and guidance
What standards apply to a clinical or diagnostic laboratory?
Medical laboratories in the UK are accredited by UKAS against ISO 15189, the international standard for quality and competence in medical laboratories. Among the things it addresses is the control of conditions, including storage environments, that can affect the quality and safety of examination results. A laboratory has to be able to show how those conditions are controlled and evidenced.
Continuous environmental monitoring supports that directly. It provides the ongoing, timestamped record of refrigerator, freezer and sample-store conditions, and the alarms that let a lab respond before stored material is compromised, which is a far stronger evidence base than periodic manual readings. Where a laboratory stores relevant human material, the Human Tissue Authority (HTA) framework may also apply.
As everywhere in regulated science, monitoring evidences conditions rather than conferring compliance or accreditation. The laboratory owns its quality management, its procedures and its response to an alarm; Eltek supplies the calibrated, continuous record and the alerts that support them. The compliance page sets out how that evidence maps to the wider frameworks.
The platform
The Darca Suite
One connected suite for the refrigerators, freezers and sample stores a clinical and diagnostic laboratory depends on.
Darca Collect
Wireless GenII transmitters and wired probes monitor refrigerators, freezers and sample stores across the laboratory, 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 alarm by grouped SMS and email, including nights and weekends, so a failing store is caught in time.
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Darca Command
Darca Command holds a continuous, time-stamped, tamper-evident record of every store, with trends, scheduled reports and role-based access, so conditions can be evidenced for UKAS assessment.
ExploreProven in regulated science
One continuous record across every store, in place of a clipboard and inevitable gaps
Eltek has monitored regulated storage in the UK for over 40 years, from laboratory refrigerators and freezers to ultra-low temperature biobank storage. Wireless GenII sensors and the cloud-connected Darca Suite give a clinical or diagnostic laboratory continuous visibility of every fridge, freezer and sample store, with SMS and email alarms that escalate out of hours and a timestamped record to evidence, for a UKAS assessor, how the conditions affecting results were controlled, all backed by UKAS-traceable calibration.
- ISO 15189
- UKAS-accredited labs
- Out-of-hours alarms
- UKAS-traceable calibration
Speak to an Eltek expert
Tell us about your refrigerators, freezers and sample stores, and our UK engineers will set up the continuous monitoring, alarms and records your laboratory and its UKAS assessment need.
Related reading
Equipment we monitor
Refrigerators, freezers, sample stores and cold rooms, and how each is monitored and alarmed.
Read moreLife Sciences compliance
MHRA data integrity, EU GMP Annex 11 and the evidence a monitoring record supplies.
Read moreMonitoring across a large, multi-zone facility
How a single connected system covers dozens of fridges and freezers without a datalogger on every door.
Read moreMore in Life Sciences
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Biotechnology & Cell and Gene Therapy
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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 do clinical laboratories need continuous temperature monitoring?
Because the storage of specimens, control materials and reagents directly affects the validity of a test, and a refrigerator or freezer that drifts out of range can compromise a result before anyone questions it. Continuous monitoring watches every store as conditions change, rather than at a twice-daily manual round, and alarms the moment something moves out of range, so material can be saved. It also produces the timestamped record a laboratory needs to evidence, for accreditation and for any clinical query, how the conditions affecting results were controlled.
How does monitoring support ISO 15189 and UKAS accreditation?
UKAS accredits medical laboratories against ISO 15189, and an assessment asks how conditions that can affect the quality and safety of results, including storage environments, are controlled and evidenced. A continuous, timestamped monitoring record answers that far more completely than periodic manual readings, which inevitably leave gaps overnight and at weekends. Eltek provides the continuous record, the alarms and the UKAS-traceable calibration that support your accreditation; the laboratory owns its quality management and procedures, and monitoring evidences conditions rather than conferring accreditation.
Can Eltek monitor every fridge and freezer across a pathology service?
Yes. A single connected Darca Suite monitors refrigerators, freezers and sample stores across haematology, biochemistry, microbiology, histology and the rest of the service, extending with repeaters and added sensors as needed, so the whole estate reports into one record rather than a standalone datalogger per unit. That gives one place to see every store, one record to evidence conditions, and one set of alarms, rather than a drawer of disconnected loggers that each have to be downloaded and checked.
What happens if a freezer fails overnight or at the weekend?
SMS450 sends grouped SMS and email alerts that escalate to the people you nominate, at any hour, so a store that begins to fail on a Friday evening is caught then, not when staff return on Monday. Escalation means that if the first person does not respond, the alert moves to the next, so a critical failure does not sit unanswered. The time-stamped record then evidences exactly when the excursion started and how long it lasted, which supports the decision on whether stored material is still fit for use.