Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-146508 IEC 60068-2-38

IEC 60068-2-38

BS EN 17111 applies to products that are used in the medical area for disinfecting instruments by immersion

Particular requirements and tests for ignition transformers for gas and oil burners

It applies to aggregates of natural or artificial origin including lightweight aggregates

according to EN 13384-1:2015

Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-146508 IEC 60068-2-38What is this standard about? This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot to lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation. This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells. The