Marya China manufacturer GAMP5 pharmaceutical water liquid preparation system
Characteristic
The formulation system is a type of pharmaceutical equipment used to mix and dispense liquids, through which adding an API to a solvent such as water for injection, and then formulating it into a pharmaceutical agent that meets the desired concentration after stirring, heating, sterilization and filtration. It is widely used in sterile or non-sterile pharmaceutical field.
Perfomance and Advantage:
1. The system can be fully automatic, with modular design, and its follow-up installation and maintenance is convenient
2. The automatic control 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 the equipment 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 corner requirements, 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.
6.We will use ANSYS fluid analysis software to simulate the real situation of the fluid in the tank, and to select suitable agitators and shears based on it, to ensure that the laboratory process can be smoothly transferred to large-scale production.
7.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.
8.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.
9.The mixing tanks are available in special shaped designs to achieve very low minimum mixing volumes.
10.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.
Including system:
Bioreactor Systems
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Medium Storage Systems
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Purification and Filtration Systems
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Buffer Solution Storage Systems
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CIP Station Cleaning System
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Waste water Inactivation Systems
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Buffer Solution Preparation Systems
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Medium Preparation Systems
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Semi-finished Product Preparation system
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