Batch control system vaccines: BCSV

Abstract

The Batch Control System for Vaccines (BCSV), a new Man Machine Interface (MMI) for the control of cultivations in bioreactors, was developed according to SP-88. SP-88 is the ISA standard for Batch Control Systems. Among others, SP-88 supplied the concept of recipes, which organize and specify the monitoring and control requirements for manufacturing. Process optimisation and compliance to GMP rules and regulations were the main objectives for this development.

The most important features of the BCSV interface include:

• - implementation at production, pilot and R & D scale to assure easy transfer of knowledge and experience at the various stage of process development;

• - independency of underlying hardware to ensure similar “look and feel” for different pieces of equipment;

• - in-house development and maintenance of recipes to have maximum control over applications;

• - interactive communication between operator and BCSV during recipe execution. GMP compliance was assured not only by considering governing sets of GMP regulations, but also by taking up the interface in a overall Information & Automation strategy and by setting up a QA strategy for the entire life cycle of the system.