International Laboratory

ISO 20387 Biobanking Standard

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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

Related Solutions

Explore ATEK monitoring solutions for ISO 20387 compliance.

ULT & Cryogenic

Ultra-low temperature and cryogenic storage monitoring.

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Research & Academia

Laboratory monitoring for research institutions.

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Biotech & Pharma

GxP-compliant monitoring for pharmaceutical manufacturing.

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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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Related Regulations

Canada

Quebec Lab Quality Guide

The Guide de gestion de la qualité des laboratoires de biologie médicale establishes the quality management standards that all medical biology laboratories in Quebec must follow. Published by the Ministère de la Santé et des Services sociaux du Québec (MSSS), this guide ensures laboratories maintain high standards for specimen handling, equipment management, and result accuracy to protect patient safety and diagnostic reliability.
Canada

QC Transport Guide

The Quebec Guide to Transport and Storage of Medical Biology Samples establishes standards for maintaining sample integrity and quality during transport throughout the province. Issued by the Ministère de la Santé et des Services sociaux (MSSS), this guide is essential for clinical laboratories, hospital networks, and diagnostic centers to ensure reliable test results. ATEK's temperature monitoring platform helps organizations meet Quebec's transport requirements through continuous monitoring, documentation automation, and real-time alerts that prevent costly sample degradation.
United States

CAP Temperature

The College of American Pathologists (CAP) establishes accreditation standards for clinical laboratories, pathology labs, and reference laboratories across the United States. CAP accreditation requires strict temperature monitoring and documentation for all laboratory equipment storing temperature-sensitive materials. These requirements ensure laboratory results are reliable, tests remain valid, and patient care is protected. ATEK's monitoring platform helps laboratories meet CAP temperature monitoring requirements through automated documentation, calibrated sensors, and comprehensive record retention.
Canada

CSA Z316.7-12

CSA Z316.7-12 is a Canadian standard that establishes requirements for the collection of specimens for clinical laboratory testing. The standard ensures specimen integrity from collection through analysis by defining procedures, documentation requirements, and quality control measures. ATEK's laboratory information management system provides the technological infrastructure needed to implement and maintain compliance with CSA Z316.7-12 requirements throughout the specimen lifecycle.
European Union

FD X 15140

FD X 15-140 is a French guidance document (fascicule de documentation) published by AFNOR that defines recommended methods for the characterisation and verification of climatic and thermostatic chambers used in laboratory and research environments. This document provides guidance on measurement methodology, spatial uniformity assessment, stability evaluation, and verification of enclosures controlling temperature alone or temperature and humidity together. ATEK's environmental monitoring platform provides comprehensive tools and capabilities to support alignment with FD X 15-140 recommendations through continuous monitoring, automated analysis, and detailed documentation.
International

ISO 15189

ISO 15189 specifies requirements for quality and competence in medical laboratories. ATEK's environmental monitoring solutions help laboratories maintain the controlled conditions essential for accurate diagnostic results and patient safety.

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