International Laboratory

ISO 20387 Biobanking Standard

ISO 20387 specifies requirements for biobanking, including the collection, preservation, and provision of biological material and associated data. ATEK's monitoring solutions help biobanks maintain the critical temperature control required for biological specimen integrity.

Authority: International Organization for Standardization (ISO)

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Why Choose ATEK for ISO 20387 Compliance

Protect Irreplaceable Samples

Continuous monitoring ensures priceless biological specimens remain viable for research.

Support Accreditation

Comprehensive documentation supports ISO 20387 accreditation and audit requirements.

ULT Freezer Protection

Specialized monitoring for -80C and cryogenic storage with early warning alerts.

Research Integrity

Documented storage conditions ensure research results are valid and reproducible.

ISO 20387 Requirements

Key compliance requirements and how ATEK addresses each one.

Requirement	Description	ATEK Solution
6.3 Facilities and Environmental Conditions	Biobank facilities must have suitable environmental conditions for biological material processing and storage.	Comprehensive Environmental Monitoring Monitor temperature, humidity, and other critical parameters across all biobank areas.
6.5 Equipment	Equipment must be suitable for its intended use and maintained according to documented procedures.	Equipment Monitoring and Tracking Monitor storage equipment performance with calibration tracking and maintenance alerts.
7.2 Collection of Biological Material	Processes for collection and handling of biological material must be defined and documented.	Collection Condition Verification Document environmental conditions during specimen collection and processing.
7.6 Preparation and Preservation	Biological material must be prepared and preserved using validated methods.	Preservation Monitoring Continuous monitoring of cryogenic storage, freezers, and refrigerated units ensures preservation integrity.
7.7 Storage of Biological Material	Storage equipment must maintain required conditions and be continuously monitored.	24/7 Storage Monitoring Round-the-clock temperature monitoring of all storage equipment with immediate alerting.
7.4 Transport	Transport processes must ensure biological material quality is maintained during transit.	Transport Monitoring Portable monitoring solutions document conditions during sample transport and distribution.
7.8 Quality Control	Quality control of biological material and associated data, including processes and data integrity.	Process Documentation Environmental data provides documented evidence of conditions during material handling.

Understanding ISO 20387

ISO 20387 was published in 2018 as the first international standard specifically for biobanking. It establishes requirements for the competence, impartiality, and consistent operation of biobanks, ensuring biological materials and associated data are fit for purpose.

Scope of the Standard

The standard applies to organizations that:

Collect biological material from humans, animals, plants, or microorganisms
Process and preserve biological material
Store biological material under controlled conditions
Distribute biological material for research and development

Environmental Control Requirements

Clauses 6.3 and 7.7 establish critical requirements for environmental control:

Facilities must maintain conditions suitable for each process
Storage must use appropriate equipment for each material type
Environmental conditions must be monitored and recorded
Procedures must address equipment failure and recovery

How ATEK Supports Biobank Operations

ATEK’s monitoring platform addresses the unique challenges of biobank storage environments.

Ultra-Low Temperature Monitoring

Biobanks rely on ULT freezers (-80C) and cryogenic storage. ATEK provides:

Specialized sensors rated for extreme temperatures
Early warning before critical thresholds
Trend analysis to predict equipment issues
Complete chain-of-custody documentation

Comprehensive Coverage

Monitor your entire biobank infrastructure:

ULT mechanical freezers
Liquid nitrogen dewars and tanks
Standard freezers and refrigerators
Ambient storage areas
Processing and handling areas

Sample Protection

Biological specimens often represent years of collection:

24/7 monitoring with immediate alerts
Battery backup for power failures
Redundant alerting via multiple channels
Escalation paths ensure response

ISO 20387 FAQs

What is ISO 20387?

ISO 20387 is an international standard that specifies requirements for biobanking, covering competence, impartiality, and consistent operation. It provides a framework for biobanks to demonstrate their ability to properly collect, process, store, and distribute biological materials.

What types of samples do biobanks store?

Biobanks store diverse biological materials including blood and serum, tissue samples, DNA/RNA, cell lines, microorganisms, and other specimens. Each type has specific storage requirements, often including ultra-low temperature (-80C) or cryogenic storage.

Why is temperature monitoring critical for biobanks?

Biological specimens are irreplaceable and temperature-sensitive. Even brief temperature excursions can degrade samples, compromise research integrity, and waste years of collection efforts. Continuous monitoring is essential to protect these valuable resources.

How does ATEK help with ISO 20387 compliance?

ATEK provides continuous monitoring of ULT freezers, cryogenic storage, and refrigeration with automated alerting and documentation. Our system helps biobanks demonstrate compliance with storage and monitoring requirements.

Can ATEK monitor cryogenic storage?

Yes, ATEK offers specialized sensors for cryogenic applications, including liquid nitrogen storage. Our systems can monitor both temperature and liquid nitrogen levels to ensure sample preservation.

What happens if a freezer fails at night?

ATEK's 24/7 monitoring with multi-channel alerting ensures staff are notified immediately of any equipment failure, regardless of time. Escalation paths ensure alerts reach someone who can respond before samples are compromised.

Need Help with ISO 20387 Compliance?

Our team of compliance experts can help you implement monitoring solutions that meet ISO 20387 requirements. Contact us for a consultation or demo.

Customized compliance assessment for your facility

Validation documentation packages (IQ/OQ/PQ)

Expert support for audits and inspections

Speak with a Compliance Expert

Our team is available to discuss your specific ISO 20387 compliance requirements.

compliance@atek.io

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