Biotechnology — Ancillary materials present during the production of cellular therapeutic products —...
This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.
This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.
This document does not cover the selection, assessment or…
Biotechnology — Ancillary materials present during the production of cellular therapeutic products —...
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…
Biotechnology — Ancillary materials present during the production of cellular therapeutic products —...
This document provides guidance for ancillary material (AM) users. It is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.
This document focuses primarily on ancillary materials (AMs) of biological (human and animal) origin and their potential impurities and contaminants.…
Graphic technology — Determination of the energy consumption of digital printing devices including t...
This document provides directions for measuring and calculating the electricity consumption of any format of digital production press, whose modes, other than production printing mode, play a significant role in the comprehensive energy consumption. It excludes digital presses designed to print substrates other than paper or plastic and conventional printing presses fitted with digital inkjet…
Ships and marine technology — Manholes with bolted covers
This document specifies requirements for watertight and oiltight manholes of the current types with bolted covers, for general shipboard use other than for pressure vessels.
It specifies the dimensions for the holes in the plating and the number, size and position of the fasteners.
It is applicable to manholes of raised coaming, surface mounted or recessed cover types.
The details of the manholes…
