生物工艺自动化和控制软件
生物工艺具有固有的波动性,因此将单元操作的条件保持在合理的范围内要求慎重调节控制参数或致动装置。控制撬装设备的工作往往非常繁琐,且要求大量的人员培训。这类人工干预可能会导致产品质量在批次间波动。
自动化和控制软件有助于减少人工作业和出错的风险,从而提升工艺的可重现性,优化正常运行时间。控制软件能够安全采集、存储和管理系统数据来供工艺监测、分析和决策之用。由于自动化和控制软件通常要求使用唯一的用户名和密码并自动保持带时间戳的审计记录,数据完整性和可靠性方面的监管合规工作得以简化。
提升产品质量和流程效率:
自动化和控制软件提升不同批次之间的一致性以及产品质量,并减少人为错误。使用软件对单元操作进行精确自动控制(比如控制流速和pH值),可以优化系统的工艺。
Bio4C Orchestrator™软件将单独的单元操作连接到中央平台,实现对系统和工艺的统一监测。
Bio4C ACE™软件控制和监测生物工艺的单元操作。它采用直观而且安全的设计,允许用户以手动或自动模式运行工艺。
相关资源
- Data Sheet: Bio4C Orchestrator™ Software
This data sheet outlines the key benefits of the Bio4C Orchestrator™ Software as well as an overview of the dashboard, modules and requirements.
- White Paper: Facilitating 21 CFR Part 11 Compliance with Bio4C Orchestrator™ Software
This white paper provides a summary as to how Bio4C Orchestrator™ Software assists in compliance with relevant 21 CFR Part 11 sections.
- White Paper: Bio4C Orchestrator™ Software Data Integrity Assessment
This paper is focused on identifying some key aspects of the latest data integrity guidance that are applicable to Bio4C™ Orchestrator, the preventative and detection controls provided.
- Data Sheet: Bio4C ACE™ Software
This data sheet outlines the features and benefits of Bio4C ACE™ software.
- White Paper: Facilitating 21 CFR Part 11 and EudraLex Volume 4 Annex 11 Compliance with Bio4C ACE™ Software
This white paper provides a summary as to how Bio4C ACE™ Software assists in compliance with 21 CFR Part 11.
- White Paper: Bio4C ACE™ Software for Mobius® Cell Retention System Data Integrity Assessment
This document describes Bio4C ACE™ software for Mobius® Cell Retention System's adherence to the Food and Drug Administration’s (FDA) data integrity guidance.
- Brochure: Process Development and Drug Manufacturing: Support Services
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
BioContinuum™平台:实现你的未来生物工厂!
- 种子扩增强化
- 生产和收获强化
- 强化捕获
- 病毒灭活
- 贯通纯化(Flow Through Polishing)
- 单程切向流过滤(TFF)
- 拉曼光谱法
- 自动无菌采样
- Bio4C ProcessPad™软件
- Bio4C Orchestrator™软件
- Bio4C ACE™软件
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