Standards Development

Scope

This document specifies requirements for the design, construction, upgrading, and infrastructure of biobank facilities to ensure optimal preservation, safety, traceability, and compliance with biosafety and security standards.

It applies to all types of biobanks (human, animal, plant, microbial, and environmental) and includes additional requirements for therapeutic and industrial biobanks as well as automated facilities.

NOTE: National, regional, or international regulations may also apply.

Purpose

Biobanks are critical for biomedical research, healthcare, industrial biotechnology, and environmental monitoring. While ISO 20387 establishes competence and general requirements for biobanking, it does not provide detailed specifications for facility design and infrastructure.

The absence of harmonized international guidance creates risks related to:

• Sample integrity and biosafety

• Safety of personnel and facilities

• Lack of interoperability and global harmonization

This new standard will:

• Define clear requirements for cryogenic storage rooms, ultra-low freezer rooms, processing laboratories, reception areas, emergency power, and automated biobanks.

• Support GMP compliance for therapeutic applications.

• Enhance global harmonization, safety, and quality of biobank facilities.

• Align with UN SDGs 1 (No Poverty), 3 (Good Health), 8 (Decent Work), 10 (Reducing Inequalities), 11 (Sustainable Cities), and 12 (Responsible Consumption).