ISO/NP 24866

Biotechnology — Bioprocessing — Information requirements and considerations for single use bag assemblies

Scope

This document specifies information requirements for single-use bag assemblies (SUBAs) used in bioprocessing applications within the biotechnology and pharmaceutical sectors.
This document defines the information to be documented and exchanged to support transparency, traceability, and consistency in the description of SUBAs.
This document is applicable to organizations involved in the specification, manufacture, supply, and use of SUBAs.
This document covers information related to design, physical dimensions, material properties, manufacturing and quality aspects, process and environmental conditions, and chemical and biological safety.
This document applies to SUBAs consisting of polymeric containers with associated components (e.g. tubing and connectors) intended for the storage, transfer, or processing of materials used in bioprocessing of cells and related products.
This document does not specify functional performance requirements, detailed design specifications, or application-specific suitability.