From the basic requirements for the application of centrifuge machines in the pharmaceutical industry and to the requirements of GMP, to ensure the reliability, repeatability, consistency, safety, and design requirements of centrifuge machines in the production process (processing specific products).
Choosing the right model is crucial to achieving GMP requirements. For some specific products and specific situations, some models are not suitable. Even if a great deal of effort is spent on structural design, it may not be able to achieve the desired effect. . The user of the centrifuge machine should specify the URS specification for the requirements of the centrifuge machine. That is to say, the user shall set specific requirements for the centrifuge machine according to the actual applied working environment, physical and chemical properties of the treatment medium, treatment requirements, and controls, and determine with the manufacturer. model.
2, material selection
The surface of the equipment that is in direct contact with the drug is required by the GMP specification to not chemically change or adsorb the drug. Therefore, for a specific medium, suitable materials should be chosen to meet the above requirements, but also to achieve the basic requirements of anti-corrosion. These materials are not just metallic materials such as drums, but all parts materials that come in contact with the material should meet this requirement, including seals, fasteners, and more.
The material is selected to meet the requirements of anticorrosion performance and cleanliness. The appropriate materials are selected according to the corrosion data (chemical properties, temperature, concentration, etc.) of the separated materials. The pipe used, for some occasions with high requirements for cleanliness, should use sanitation grade pipes and hygienic quick-install cards to eliminate the pollution that the pipeline may bring, and it is also easy to clean.
3, structural design and surface treatment
In the design, the joint surface should be reduced (eliminated) as much as possible to eliminate the dirt caused by the gaps in these joint surfaces and difficult to clean. Welding joints should be continuous (uninterrupted welding), fillet welds should be ground into a smooth transition fillet, butt welds should be flat. All sharp corners and corners must be round corners to create a smooth transition of the rounded corners, eliminate projections and pits as much as possible, eliminate health corners, eliminate dead spots such as effusion, accumulation of material. All stainless steel surfaces should be polished to minimize the adhesion of contaminants on the surface of the equipment and improve cleaning results.
When the centrifuge machine is being overhauled, maintenance personnel, tools, spare parts, etc. will cause contamination in the aseptic workshop. Therefore, the design of the centrifuge machine should be simple in structure, convenient for disassembly, convenient transportation, and ensure the rationality and reliability of the product structure.
4, online cleaning
Ensure that each batch of products can achieve consistency, to prevent the structure of the product itself and the contamination of microorganisms, germs, etc. In the design should consider the installation of cleaning, disinfection, sterilization devices (users can accept the program). All surfaces need to be easily cleaned and do not cause contamination or chemical reactions in the product during production.
Multiple cleaning heads or cleaning tubes are installed in the centrifuge machine chamber (if necessary at multiple locations). The centrifuge machine can clean the invisible surface of the centrifuge machine without opening or running.
The pharmaceutical centrifuge machines, whether they are non-sterile or sterile drugs, are intermediates or finished drugs, and they place high demands on the environment during the production process. Under high-grade environmental requirements, such as in a sterile workshop, there are Class C, Class D, and other aseptic plants, and good containment performance can maintain effective isolation between the exterior and the interior of the machine. The solid, liquid, and gas phases in the centrifuge machine cavity must not cause contamination in the workshop environment; in turn, the operators and the external environment must not be able to cause contamination of the material. Therefore, the pharmaceutical manufacturer should inform the manufacturer of the centrifuge machine at the time of ordering and make a seal request.