application area
Mainly used for material preparation in industries such as sterile injections, intravenous infusion, oral liquid, and fine chemistry, it can effectively eliminate risks of cross contamination and product contamination during the preparation process, improve product production efficiency and reliability.
According to the pharmacopoeia and regulations, sterile examination items are divided into sterile preparations (such as freeze-dried injections, water injections, etc.) and non sterile preparations (such as tablets, capsules, etc.).
Sterile preparations can be divided into final sterilization production processes (such as intravenous infusion, water injection, traditional Chinese medicine injection, etc.) and non final sterilization production processes (freeze-dried powder injection, vaccine, blood products, etc.) according to production processes.
Design process
The beginning of design is conceptual design, which is based on the URS provided by the user or documents used to describe the production requirements of the user's product. It determines the dosage form, production process route, production capacity, production operation mode, operation layout, utility consumption, construction scope, automation control degree, and other contents, and makes a budget and procurement plan for the project.
The next stage of design is the basic design, which includes completing the floor plan, P&ID diagram, process control manual FDS, project execution plan (risk analysis RAM, procurement plan PMC, project quality control plan QPP), and completing the project quotation document. The final stage of design is detailed design, completing construction drawings, 3D design drawings, procurement control documents, and ultimately confirming the design with the user.
