一种新的生物制药生产区结构设计方案的探讨

Discussion on Structure Design of Biopharmaceutical Production Workshop

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。

Biopharmaceutical is significantly different from the traditional Chinese medicine and chemical medicine. The manufac- turing process of the biopharmaceutical is extremely complex and greatly demanding on the environment. The process of biopharma- ceutical is step tedious and complex which includes up stream cell culture and down stream separation and purification. Each produc- tion process should get together closely, but the requirements such as the degree of environmental cleanliness, the logistics flow control,the cross contamination control etc. of each functional area are quite different. Therefore, the biopharmaceutical workshop required detailed partition and each functional area should be closely co-ordinated and strictly isolated. The core issues of biopharma- ceutical production workshop design were discussed in this article from some respects such as the status of biopharmaceutical indus- try, cleanliness of bio-pharmaceutical workshop, control of logistics flow, workshop structure design and so on. Based on the specifica- tion requirements above and combining with the characteristics of the traditional biopharmaceutical workshop structure design, a new kind of biopharmaceutical production workshop structure design scheme is discussed in this article. According to the new biopharma- ceutical workshop design scheme, on one side,it can reduce the proportion of the clean area, reduce the energy consumption of the clean area and reduce the cross contamination, on the other side, it can also be benefitial to both the behavior of the equipment main- tenance and overhaul daily and the activity of the workshop visit. The biopharmaceutical workshop design scheme discussed in this paper can provide a new way to design the workshop for biopharmaceutical production in the future.