ISO 20070:2025

Overview

ISO 20070:2025 - "Biotechnology - Biobanking - Requirements for primary containers for storing biological materials in biobanks" defines minimum requirements and test methods for primary containers that directly contact and store biological material in biobanks. The standard sets a framework for manufacturer responsibilities, product specifications, documentation, quality control, and conformity testing to ensure containers do not compromise the integrity, stability or traceability of stored biological materials. It is primarily aimed at manufacturers but is also intended for biobanks, material submitters, users and regulatory/oversight organizations. (Note: containers for therapeutic-use biological material may be subject to additional requirements.)

Key Topics

• Scope and definitions: Clear definitions (e.g., primary container, nominal/working volume, extractable, leachable, minimum durability date) to harmonize terminology across biobanking operations.
• Manufacturer requirements: Design and production validation, including validation of leak-resistance, extractables/leachables, and dimensional stability under temperature/pressure.
• Container requirements:
  • Suitability for storage conditions and duration (cold, cryogenic, ambient)
  • Transport suitability and mechanical stability
  • Compatibility with technical methods (automation, microplates, racks)
  • Compatibility with biological material to avoid adsorption/absorption or contamination
  • Leak-resistance and aging behaviour
• Test methods and criteria: Defined test methods for stability, leak-resistance, release of substances, adsorption/absorption, and mechanical changes, plus guidance on test reporting and sampling.
• Labelling and traceability: Requirements for identifiability, traceability and labelling verification (including bar code quality considerations).
• Quality control and documentation: Product specifications, batch control, minimum durability date and risk assessment requirements.

Applications

• Ensures reliable storage of specimens (DNA, tissues, biofluids, cell suspensions) in research, diagnostics and biobanking networks.
• Enables manufacturers to demonstrate conformity for product claims (leak-proof, low extractables/leachables, cryo-stable).
• Supports biobanks in selecting validated primary containers to preserve sample integrity for long-term storage, sample exchange and high-throughput/automated workflows.
• Assists conformity assessment bodies, auditors and quality managers in evaluating container performance and supplier documentation.

Related standards

• ISO 20387 - Biotechnology - Biobanking - General requirements for biobanking
• ISO/IEC 15416 - Bar code print quality test specification
• ISO 2859-1 / ISO 2859-2 - Sampling procedures for inspection by attributes
• ISO 8601-1 - Date and time representations
• ISO 10993 series (for extractables/leachables definitions)
• Relevant microplate format guidance (ANSI/SLAS dimensions, SBS layouts)

Keywords: ISO 20070, biobanking, primary containers, storage of biological materials, leak-resistance, extractables, leachables, test methods, labelling, container validation, biobank quality.