ISO 24088-1:2022

Overview

ISO 24088-1:2022 - Biotechnology - Biobanking of microorganisms - Part 1: Bacteria and archaea - specifies requirements for the competent operation of microbial biobanks handling bacteria and archaea. The standard covers management of microbial materials and associated data, together with biosafety and biosecurity requirements. It is intended for organizations that perform biobanking for research and development and complements existing national or regional regulations.

Key SEO keywords: ISO 24088-1, biobanking, microorganisms, bacteria and archaea, biosafety, biosecurity, microbial biobank, data management.

Key topics and technical requirements

ISO 24088-1 sets out a lifecycle‑oriented framework for microbial biobanking. Major topics include:

• General and legal requirements - governance, compliance with applicable laws and regulations.
• Health, safety and biosecurity - laboratory biosafety practices, chemical safety, personal protective equipment, controlled access to biosecure areas.
• Personnel and facilities - competency of staff, facility layout, biosafety cabinets, backup storage and contingency planning.
• Critical equipment - requirements and calibration expectations for incubators, refrigerators, ultra‑low temperature freezers, liquid nitrogen systems, autoclaves and automated storage.
• Process requirements - acquisition/deposit procedures, review and acceptance of materials, authentication, purity control, passage control, and preservation of master and distribution stocks.
• Distribution, packaging and transport - controls for review, agreements, secure packaging and shipping.
• Information and data management - minimum and recommended data sets, accession/lot numbers, inventory management and information system requirements to ensure traceability.
• Quality control, validation and reporting - QC of materials and methods, validation/verification of procedures, complaint handling and reporting.

The standard deliberately excludes processing methods for microbial materials intended for food/feed production, routine food/feed analysis, and therapeutic use.

Practical applications and who should use it

ISO 24088-1 is relevant to:

• Public and private microbial culture collections and biobanks
• University and research institute laboratories that store bacterial and archaeal strains
• Biotech and pharmaceutical R&D groups maintaining microbial stocks for discovery and development
• Public health and environmental microbiology repositories
• Quality, compliance and biosafety managers seeking standardized controls for storage, traceability, and secure distribution

Adopting ISO 24088-1 helps reduce risks of misidentification, contamination, genetic drift and loss of viability, improving reproducibility of research and confidence in shared microbial resources.

Related standards

• ISO 20387:2018 - Biotechnology - Biobanking - General requirements for biobanking
• ISO 21710:2020 - Data management and publication in microbial resource centers
• ISO 15190:2020 - Medical laboratories - Requirements for safety
• ISO 45001:2018 - Occupational health and safety management systems
• WHO Laboratory biosafety manual (4th ed.)

Use ISO 24088-1 as a practical roadmap for establishing robust, traceable, and secure biobanking practices for bacteria and archaea.