Classification of the preparation system：

1）General preparation system: It is used for general small molecule chemical preparation, such as aqueous injection, lyophilized powder injection and so on.

2）Complex preparation system: It is used in the production of preparations with complex processes, such as suspensions, emulsions, liposomes, microspheres and other special preparations.

3）Biological preparation system: It is used for the preparation of all kinds of products applying biological engineering technology, such as the semi-finished preparation of antibodies, vaccines, blood products, recombinant proteins and so on, and it can also be used for the production of culture medium, purification buffer and other auxiliary liquid preparation.

4）CIP station system: It is used to assist in the on-line cleaning of tanks and pipelines of various preparation and bioreactor systems, and can be controlled separately or integrated with other systems.

Performance Characteristics of the preparation system：

General preparation system

1. The system can be fully automatic, withmodular design, and its follow-up installation and maintenance is convenient.
2. The automaticcontrol system of CIP and SIP can be turned on by one key, which can automatically detect the end of cleaning and sterilization, with recipe management, electronic signature, electronic records, audit tracking and other computer functions.
3. When theequipment is running, it can realize controllable production of key process parameters of drugs (such as temperature, dissolved oxygen, PH, etc.), and can automatically detect them and give an alarm when there are special conditions outside the set parameters, so as to avoid quality problems of drugs.
4. The system follows ASME BPE and GMP design concepts, meets 3D blind cornerrequirements, and allows for low residue and continuous production.
5. Before manufacturing the equipment in our factory, we will carry out one-to-one three-dimensional design to rationalize the arrangement of pipelines, valves, instruments, etc. in the system to make the operation of the equipment more user-friendly.

Complex preparation system

1. We will use ANSYS fluid analysis software to simulate the real situation of the fluid in the tank, and toselect suitable agitators and shears based on it, to ensure that the laboratory process can be smoothly transferred to large-scale production.
2. We will use high-precision oil & water phase transfer pumps to strictly control the mixing ratio of oil and water phase to ensure the emulsification effect.
3. If there are hazardous raw materials for the production of pharmaceuticals, we will install isolators in the feeding area of the preparation system to ensure the sterility of the API feeding process and personnel protection.
4. The mixing tanks are available in special shaped designs to achieve very low minimum mixing volumes.
5. For suspension products, we will adopt the circulating pipeline design to avoid the uneven composition of the product due to the settling of suspended particles in the pharmaceutical agent caused by long-time filling.

Biological preparation system

1. The preparation system communicates with the fermentation system and the purification system, and can automatically deliver the culture medium and purified auxiliary liquid to the specified position, and can be switched flexibly.
2. The steel frame and tanks of the preparationsystem can be placed in Class C and Class B areas respectively, reducing the risk of contamination due to personnel handling.
3. We use double valvesand valve feedback unit in the key parts of the equipment, so that there is no risk of cross-contamination between the cleaning and the material pipeline.
4. The system is equipped with an aseptic collection tank and theliquid filter cartridge can be carried out on-line integrity testing after SIP, in compliance with EU GMP and FDA

The equipment adopts SCADA automatic control system, which can monitor and control the field equipment at any time, and realize data acquisition, equipment control, measurement, parameter adjustment and all kinds of signal alarms, etc. in the central control room.