RIVM, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands.
Cytotechnology. 1995 Jan;18(1-2):57-66. doi: 10.1007/BF00744320.
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.
疫苗批处理控制系统（BCSV）是根据 SP-88 开发的一种用于生物反应器培养过程控制的新型人机界面（MMI）。SP-88 是批处理控制系统的 ISA 标准。其中，SP-88 提供了配方的概念，这些配方组织并指定了制造过程的监控和控制要求。过程优化和符合 GMP 法规是这项开发的主要目标。BCSV 界面的最重要特点包括：- 在生产、中试和研发规模上实施，以确保在工艺开发的各个阶段轻松转移知识和经验；- 底层硬件的独立性，以确保不同设备具有相似的“外观和感觉”；- 内部开发和维护配方，以最大程度地控制应用程序；- 在配方执行过程中，操作员与 BCSV 之间的交互式通信。不仅通过考虑一套套的 GMP 法规来确保符合 GMP 要求，还通过将接口纳入整体信息和自动化策略，并为系统的整个生命周期建立 QA 策略来确保 GMP 合规性。
