Standards Manage Your Business
We Manage Your Standards
Standards Manage Your Business
We Manage Your Standards
Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use
This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials.
This document does not apply to:
a) receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag;
b) shipping containers containing packages for transportation;
c) services that utilize packages, e.g. storage services.
NOTE 1 Examples of packaging, packages and shipping containers are illustrated in Annex A.
NOTE 2 The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management.
NOTE 3 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Currently Viewing
Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!
© Copyright 2024 BSB Edge Private Limited.
