ISO 20387 is the international standard for biobanking. Since its publication in 2018, it has established itself as the global reference for competence, quality assurance, and sample integrity in facilities that store biological materials for scientific use.
For biobanks building scientifically usable sample collections — for genomics research, clinical trials, or longitudinal population studies — ISO 20387 is not optional. Without demonstrated compliance, samples from recognized biobanks are increasingly rejected by major research institutions and multi-center study coordinators.
ISO 20387 (Biotechnology — Biobanking — General requirements for biobanking) defines requirements in three core areas:
Management system: Quality assurance, documentation, internal audits, non-conformance management
Technical competence: Requirements for personnel, equipment, environmental conditions, sample processing
Sample integrity: Quality from collection through use, traceability, long-term stability
The standard builds on ISO/IEC 17025 (accreditation standard for testing laboratories) and ISO 9001:2015 (quality management). Biobanks with existing ISO 9001 certification have a significant foundation already in place.
Facilities conducting purely internal research without providing samples to external partners can operate without ISO 20387 — but they lose the ability to contribute samples to multi-center studies or collaborative projects.
Section 7 (Technical requirements) of ISO 20387 sets out equipment and environmental requirements with direct consequences for cryogenic systems:
Consarctic® qualifies all delivered cryogenic tanks and BIOFREEZE® controlled rate freezers through certified technicians. IQ/OQ documentation is suitable for regulatory use and serves as the basis for ISO 20387 equipment qualification.
The monitoring system provides continuous, calibrated temperature data for all tanks — with timestamps, alarm records, and export functions for audit documentation. Data formats align with ISO 20387 environmental monitoring requirements.
The BSD+ Series (up to 100,000 cryovials) and BSF+ Series (up to 1,700 cryobags) are designed for large-scale biobank storage. Vapor phase storage eliminates cross-contamination risks — a requirement for multi-patient sample collections.
The emergency plan (ISO 20387 Section 7.5) requires documented procedures for system failure. Consarctic® provides 24/7 emergency service with guaranteed response times — serving as the contractually secured foundation for the emergency plan.
Gap analysis: Comparing existing practice with standard requirements
System build: Implementing missing documentation and quality assurance processes
Equipment qualification: IQ/OQ for all relevant instruments
Internal audit: Verification of implemented measures
Accreditation audit: Assessment by an accredited body
Accreditation: Issuance of ISO 20387 certification
The typical timeline from project start to accreditation is 12 to 24 months.
ISO 20387 is the international standard for biobanking (Biotechnology — Biobanking — General requirements). It defines requirements for management systems, technical competence, and sample integrity in facilities storing biological materials for research and application.
Not legally mandatory in most jurisdictions, but increasingly a de facto requirement. Research institutions and funding bodies require ISO 20387 compliance as a condition for accepting externally contributed samples and participation in multi-center studies.
Not necessarily. For purely internal research without providing samples to external partners, ISO 20387 is not required. Once samples are provided to external collaborators or contributed to consortium projects, compliance becomes increasingly expected.
From gap analysis to accreditation, 12 to 24 months is a realistic expectation. Timeline depends on the starting point (existing quality systems, equipment status) and available internal resources.
All equipment that directly affects sample integrity: cryogenic storage tanks, controlled rate freezers (e.g., BIOFREEZE®), temperature sensors, monitoring systems, reagent refrigerators. Consarctic® delivers complete qualification documentation for all cryogenic systems.
ISO 20387 certification is not bureaucratic overhead. It is the demonstration that a biobank meets scientific standards that are increasingly required as a baseline condition for national and international research collaborations.
Consarctic GmbH supports biobanks on the technical side of ISO 20387 compliance: equipment qualification, monitoring systems, service, and documentation. With reference customers including the Qatar Biobank and the Finnish Red Cross, contact us to discuss your path to certification.