Implementation Guide - Use of the Manufacturers Data File v1.2.1

Manufacturers of blood containers maintain electronic data files which contain vital information such as the anticoagulant, additives, presence of leukocyte reduction filter, and volume limits of the container. Customers can download the relevant data files to their own computer system to use the data for process control when manufacturing blood products.

This document provides background information and examples of the use of the ISBT 128 Manufacturers Data File. It provides supplementary information only and is intended to be used in conjunction with the ISBT 128 Standard Technical Specification (ST-001) which contains specifications relating to the Manufacturers Data File.

Main sections:

- Background

- ISBT 128 Manufacturers Data File structure

- Information contained in the Manufacturers Data File

- Illustration of a data file

- How the Manufacturers Data File may be used

- Process control applications

- Information for manufacturers of blood containers and software vendors - structure of the data file

- Specific issues for container manufacturers

- Specific issues for software vendors

- Example files