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Based on the basic requirements for the application of centrifuges in the pharmaceutical industry and the specific requirements for GMP, design requirements are proposed to ensure the reliability, repeatability, consistency, and safety of the pharmaceutical centrifuge machine in the production process when handling specific products.
For certain specific products and occasions, some models are not suitable, and even with significant structural design efforts, the expected results may not be achieved. Pharmaceutical centrifuge machine users should specify their centrifuge requirements (URS) based on the actual application environment, the physical and chemical properties of the processing medium, processing requirements, and controls. These requirements will help manufacturers determine the most suitable model.
GMP standards require that surfaces in direct contact with pharmaceuticals do not undergo chemical changes or adsorb the drugs. Therefore, appropriate materials should be selected for manufacturing to meet these requirements and to achieve fundamental corrosion resistance. These materials are not limited to metal parts like drums but include all parts that come into contact with the materials, such as seals and fasteners.
In the design process, the pharmaceutical centrifuge machine should minimize joints to eliminate the issue of dirt accumulation and difficulty in cleaning these gaps. Welding joints should be continuous and uninterrupted. Fillet welds should be ground to smooth transitions, and butt welds should be ground flat. All sharp and cornered edges must be rounded to eliminate any protrusions and pits, preventing sanitary dead corners and issues like liquid and material build-up. All stainless steel surfaces should be polished to reduce the adhesion of contaminants and improve the cleaning effectiveness.
Pharmaceutical centrifuge machine, whether for non-sterile or sterile drugs, poses high environmental requirements during production. In high-level environments like 10,000 and 100,000 grade sterile workshops, excellent sealing performance can effectively isolate the external environment from the machine interior. Simultaneously, for applications involving organic solvents like methanol, ethanol, and toluene, the explosion-proof design of the centrifuge is crucial to ensure safety during production.
To ensure product quality and production consistency, pharmaceutical centrifuge machines should be designed with cleaning, disinfection, and sterilization devices. All surfaces should be easy to clean to prevent contamination or chemical reactions during production. Multiple cleaning heads or cleaning pipes should be installed inside the centrifuge to clean the internal invisible surfaces during operation.
The above is an overview of several technical requirements for pharmaceutical centrifuge machines in the pharmaceutical industry. These requirements not only comply with GMP standards but also ensure the safety, efficiency, and reliability of centrifuges in the pharmaceutical process. For the pharmaceutical industry, choosing and designing suitable centrifuges is vital as it directly relates to improving product quality and production efficiency.