ISO 24190:2023 PDF

Overview

ISO 24190:2023 - "Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses" - provides a flexible, risk-based framework for selecting and validating rapid microbial test methods (RMTMs) used in cellular therapeutic product manufacturing. The standard focuses on sterility testing for cellular therapeutics and cell-derived products, addressing both in-process and final product testing to support timely patient administration. Viral testing is excluded from this document.

Key technical topics and requirements

• Risk-based approach: Guidance on identifying microbiological contamination risks across unique manufacturing processes and on prioritizing controls and testing strategies.
• Assay and system selection: Criteria for selecting fit-for-purpose assays, kits or systems considering speed, sample volume, specificity and sensitivity.
• User requirement specifications (URS): Defining acceptance criteria and performance expectations for RMTMs (e.g., speed, limit of detection, analytical specificity).
• Validation principles: Quality-by-design for method validation, selection of microorganisms for validation, use of reference materials, and revalidation triggers.
• Validation parameters: Establishing acceptance criteria for precision, detection limit, accuracy, robustness and ruggedness, plus system validation.
• Operational guidance: Recommendations on number/type of samples, testing environment, comparable test data, investigation of positive sterility results, training, documentation and test reporting.
• Informative annexes: Practical tools and examples including risk analyses for input materials and process stages, validation examples, microorganism lists for validation, methods for RMTMs, and environmental control guidance.

Practical applications and intended users

ISO 24190 is intended for organizations involved in development, manufacture and quality control of cell-based and other cell‑derived therapeutics, including:

• Quality assurance / Quality control (QA/QC) teams
• Microbiology and analytical method developers
• Cell and gene therapy manufacturers
• Regulatory affairs and compliance professionals
• Contract development and manufacturing organizations (CDMOs)

Practical uses include establishing RMTM selection criteria, designing validation studies for rapid sterility tests, integrating rapid testing into short-shelf-life workflows, and documenting risk-based testing strategies to support product release and patient safety.

Related standards and context

• Complements pharmacopeial culture-based sterility approaches by enabling rapid microbial detection where time-sensitive decisions are required.
• Builds on definitions and measurement concepts referenced in related ISO documents (e.g., ISO 16140, ISO 18113) and aligns with ISO/TC 276 biotechnology guidance.

Keywords: ISO 24190, rapid microbial detection, RMTM, cellular therapeutics, sterility testing, method validation, risk-based approach, bioprocesses, QA/QC.