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生物制药不同于中药、化药,生产制造过程复杂,且对生产环境要求较高。生物制药流程包括上游细胞培养和下游分离纯化,生产工序较多,参数控制要求也比较高。各生产工序紧密衔接,对环境洁净程度、人流物流控制、交叉污染控制等要求差异大,因此生产车间需详细分区,各功能区紧密衔接又严格隔离。该文将针对上述要求,探讨一种新的生物药生产区设计方案,以求较好的解决上述问题。该方法从生物制药现状、生物制药车间洁净度、人流物流控制、生产区结构设计等方面论述了生物制药生产车间设计中的核心问题。结合目前传统生物制药生产车间结构设计特点,探讨了一种新的生物制药生产区结构设计的方案。本设计方案可以减少洁净区面积、降低洁净区运行能耗,减少交叉污染风险,同时又利于设备日常维护检修、车间参观视察工作。该文讨论的方法可为未来生物药生产车间设计提供一种新的思路。
Biopharmaceuticals are different from traditional Chinese medicines, chemical drugs, complex manufacturing processes, and higher requirements on the production environment. Biopharmaceutical processes include upstream cell culture and downstream separation and purification, more production processes, parameter control requirements are relatively high. Closer connection between the various production processes, the cleanliness of the environment, the flow of people flow control, cross-contamination control and other requirements vary greatly, so the production workshop needs detailed zoning, the functional areas close cohesion and strict isolation. This article will address the above requirements, to explore a new bio-drug production area design, in order to better solve the above problems. The method discusses the core issues in the design of the biopharmaceutical workshop from the aspects of the biopharmaceutical status, the cleanliness of the biopharmaceutical workshop, the flow control of the pedestrian flow and the structural design of the production area. In combination with the structural characteristics of the traditional biopharmaceutical manufacturing workshop, a new structural design scheme of biopharmaceutical production area was discussed. The design scheme can reduce the area of the clean area, reduce the energy consumption of the clean area, reduce the risk of cross-contamination, and at the same time facilitate the routine maintenance and repair of the equipment and the workshop visit and inspection. The method discussed in this article can provide a new idea for the future design of biopharmaceutical manufacturing plant.