ISO/FDIS 20404

Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use

Scope

This document provides minimum requirements, and general considerations for the design of packaging used to contain cells for therapeutic use.
This document is intended to help the supplier of packaging to design and manufacture packaging in consideration of enclosing, storage, transportation and utilization processes of cells for therapeutic use. This document is also intended to help the users of packaging to design and employ packaging in consideration of the above-mentioned processes.
This document is also applicable to packaging intended to contain final products of cells for therapeutic use, as well as their starting materials and intermediate materials.
This document does not specify:a) receptacles used for processing cells in manufacturing processes, e.g., cell culture flask or bag;b) shipping container, in which to contain package for transportation;c) services performed with package, e.g. storage service.
NOTE 1 Examples of packaging, package and shipping container are illustrated in Annex A.NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.