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Starting from the basic requirements and GMP requirements for the application of centrifuges in the pharmaceutical industry, design requirements are proposed to ensure the reliability, repeatability, consistency, and safety of pharmaceutical centrifuge machine in the production process.
Choosing the right model is crucial for achieving GMP requirements. For certain specific products and occasions, some models may not be suitable, even if a lot of effort is put into the structural design, it may not achieve the expected results. Users of the pharmaceutical centrifuge should propose a specification URS for the centrifuge requirements, that is, users should provide specific requirements for the centrifuge together with the manufacturer based on the working environment, physicochemical properties of the processing medium, processing requirements, control, etc.
GMP specifications require that the surface of equipment that directly contacts with drugs does not chemically change or adsorb the drugs. Therefore, suitable materials should be used to manufacture for specific media to meet the above requirements, as well as to achieve basic requirements for corrosion protection. These materials are not only metal materials such as drums but also all parts that come into contact with the material, including sealing parts, fasteners, etc.
The selection of materials is critical for achieving corrosion resistance and cleanliness requirements. Suitable materials should be selected based on the corrosion data (chemical properties, temperature, concentration, etc.) of the separated materials. For some occasions with high cleanliness requirements, sanitary pipes and sanitary quick couplings should be used to eliminate possible pollution from the pipeline and facilitate cleaning.
During design, as much as possible, the number of joint faces should be reduced (eliminated) to eliminate the dirt that these joint face gaps carry that is difficult to clean. Welded joints should be continuous (without interruption), angles should be rounded smoothly, and butt welds should be ground flat. All sharp corners and turning corners must be rounded to produce a smooth transition of rounded corners, eliminate protrusions and depressions as much as possible, eliminate sanitary blind spots, and eliminate dead corners where liquids and materials can accumulate. All stainless steel surfaces should be polished to reduce the adhesion of pollutants on equipment surfaces and improve cleaning efficiency.
During maintenance of pharma centrifuge machine, maintenance personnel, tools, spare parts, etc. can cause contamination to aseptic workshops. Therefore, the design of centrifuges should be simple, easy to disassemble, transportable, and ensure the rationality and reliability of the product structure.
High-level environmental requirements are proposed during the production process of pharmaceutical centrifuge machine whether it is for non-sterile drugs or sterile drugs, drug intermediates, or finished drugs. Under high-level environmental requirements, such as in aseptic workshops, good sealability can effectively isolate the external environment from the inside of the machine. The solid, liquid, and gas phases in the centrifuge cavity should not cause pollution to the workshop environment; conversely, the operator and the external environment should not cause pollution to the material. Therefore, pharmaceutical manufacturers should inform the pharma centrifuge machine manufacturer about the sealing requirements when placing an order.