Design And Validation Of Liquid Mixing System Of Large-volume Injection Workshop

Objectives: Based on the study of Chinese Pharmacopoeia(Ch.P. 2010), Good Manufacture Practice(GMP) and their appendixes, and on the understanding of preparing process of sterile preparations, design and construction of the liquid mixing system of large-volume injection workshop was carried out according to GMP by combining the present situation of the new developed large-volume injection workshop of our company together. The liquid mixing system is the most important core and complicated part of large-volume injection workshop. Our purpose is to enhance the automation degree, avoid error operation risk and improve sterile guarantee level on the promise of conformance to laws and regulations. Moreover, the actual manufacture demand and save of investment cost is considered as well. The study is intended to provide reference to similar construction projects of pharmaceutical enterprises.Contents: Liquid mixing system is divided into five modules in large-volume injection workshop. Respectively, they are liquid dispensing system, filtration system, storage system, pipeline system and process control. This work focuses on how to design and build a set of liquid mixing system of large-volume injection workshop with regard to the laws and regulations, product process flow and actual production demand. The following aims are expected to ensure the liquid mixing system passing all of the authentications, clear liquid flow, simple pipeline system, no dead angle and blind pipe, complete discharging, thorough cleaning and sterilization, no cold spots during sterilization and highly precise formulation.Results: By the design and construction of the whole set of liquid mixing system, the developed fluid system is available to meet daily production demand, take both the maximum capacity and minimum production capacity into account, and match the subsequent production equipment as well to reduce the microparticulate and microbial contamination risk of materials being processed and to avoid any contamination and cross-contamination as far as possible.Conclusion: The liquid mixing system built according to the design and construction scheme in this work can meet the requirement of reducing the risk of sterile operation prescribed in GMP(2010), realize the automation of liquid formulation and online monitoring, alarming and real-time recording, be convenient for operation and avoid error operation risk. On the other hand, it can solve the actualmanufacture problems and save investment. This work may give reference to related pharmaceutical engineering projects.