Views: 0 Author: J-VALVES Publish Time: 2022-05-27 Origin: Site
C95800 NICKEL ALUMINUM BRONZE is a copper alloy with nickel and aluminum as the main alloying elements, possessing the following remarkable performance characteristics:
C95800 NICKEL ALUMINUM BRONZE exhibits excellent corrosion resistance in a variety of corrosive environments, especially in those containing media such as ammonia, seawater, and acidic gases. Its corrosion resistance mainly benefits from the synergistic effect of nickel and aluminum in the alloy. Nickel can enhance the corrosion resistance of the alloy, while aluminum forms a dense oxide film on the surface of the alloy, further strengthening the corrosion resistance.
C95800 NICKEL ALUMINUM BRONZE has relatively high mechanical strength and good wear resistance, capable of withstanding large fluid pressures and mechanical impacts. Its tensile strength can reach above 600 MPa, and its hardness is between 200 - 250 HB. Such high strength and wear resistance enable it to perform excellently in high-pressure and high-flow filtration systems in the pharmaceutical industry.
C95800 NICKEL ALUMINUM BRONZE has good casting and machining properties, making it convenient to manufacture complex strainer structures. Its machinability is superior to that of some high-strength stainless steels and titanium alloys, and it can meet the requirements of the pharmaceutical industry for strainer precision and complex structures.
The FDA has strict requirements for the materials of pharmaceutical equipment to ensure the safety, effectiveness, and quality controllability during the drug production process. The following are the main FDA compliance requirements for pharmaceutical equipment materials:
The materials of pharmaceutical equipment must have good chemical stability and should not react chemically with drugs or production media to avoid adverse effects on drug quality. The FDA requires that the equipment materials do not release harmful substances, especially heavy metal ions, during the use process.
The materials of pharmaceutical equipment need to pass biocompatibility tests to ensure that they will not pose a hazard to human health. According to the ISO 10993 standard, biocompatibility tests cover multiple aspects such as cytotoxicity, sensitization, and irritation.
The materials of pharmaceutical equipment must be able to be easily cleaned and disinfected to prevent microbial contamination and cross-contamination. The FDA requires that the equipment materials maintain good performance during repeated cleaning and disinfection processes.
Enterprises need to provide detailed component information of materials, Material Safety Data Sheets (MSDS), biocompatibility test reports, toxicity assessment reports, and other documents to prove the compliance of the materials.
In the pharmaceutical industry, the FDA has strict requirements for material compliance. The FDA compliance of C95800 NICKEL ALUMINUM BRONZE is mainly reflected in the following aspects:
The FDA has clear limitations on the composition of materials in contact with food and drugs, especially for metal elements that may migrate into drugs. The main components of C95800 NICKEL ALUMINUM BRONZE include copper, nickel, and aluminum, etc. The contents of nickel and aluminum need to be strictly controlled. According to relevant FDA regulations, the content of nickel is usually limited to below 0.1% - 1%. The composition of C95800 nickel aluminum bronze meets the FDA's requirements for the migration amount of metal elements and can ensure that it will not cause pollution to drugs during the use process.
Biocompatibility is one of the key factors in material selection in the pharmaceutical industry. C95800 nickel aluminum bronze needs to pass a series of biocompatibility tests, such as cytotoxicity tests, sensitization tests, and irritation tests. These tests can ensure that the material will not have adverse effects on human health during contact with drugs. Currently, C95800 nickel aluminum bronze has passed relevant biocompatibility tests and meets the requirements of the FDA.
During the pharmaceutical production process, strainers may come into contact with various chemical substances and high-temperature environments. C95800 NICKEL ALUMINUM BRONZE has good chemical stability and thermal stability and can maintain its performance under these harsh conditions. Its corrosion resistance and high-temperature resistance enable it to work stably for a long time under various working conditions in the pharmaceutical industry, meeting the FDA's requirements for material stability.
To more intuitively show the advantages and limitations of C95800 nickel aluminum bronze in the material selection for T-TYPE STRAINERS in the pharmaceutical industry, the following is a comparative analysis of C95800 nickel aluminum bronze and several other commonly used materials.
Material Type | Corrosion Resistance | Strength and Wear Resistance | Biocompatibility | Cleanability and Disinfectability | Cost |
C95800 Nickel Aluminum Bronze | High (resistant to seawater, acidic gases, etc.) | High (tensile strength above 600 MPa) | Medium (requires surface treatment) | High (resistant to high-temperature disinfection) | Medium |
Stainless Steel (316L) | Medium (resistant to weak acids and weak alkalis) | Medium (tensile strength around 550 MPa) | High (no allergens) | High (resistant to high-temperature disinfection) | Low |
Polytetrafluoroethylene (PTFE) | High (resistant to strong acids and strong alkalis) | Low (mechanical strength low) | High (no allergens) | High (resistant to chemical disinfection) | High |
Titanium Alloy (Ti6Al4V) | High (resistant to seawater, acidic media) | High (tensile strength above 800 MPa) | High (no allergens) | High (resistant to high-temperature disinfection) | High |
In summary, as a high-performance copper alloy, C95800 NICKEL ALUMINUM BRONZE has significant application advantages in T-TYPE STRAINERS in the pharmaceutical industry. Its excellent corrosion resistance, high strength, wear resistance, as well as good biocompatibility and FDA compliance, enable it to meet the strict requirements of the pharmaceutical industry for sTRAINER materials. Compared with other common materials, C95800 nickel aluminum bronze is more competitive in comprehensive performance. Pharmaceutical enterprises should comprehensively consider factors such as material performance, cost, and compliance when selecting STRAINER materials. Undoubtedly, C95800 nickel aluminum bronze is a recommended choice. In the future, with the continuous improvement of the pharmaceutical industry's requirements for material performance, C95800 nickel aluminum bronze is expected to be applied in more fields, providing a powerful guarantee for the safety and quality of drug production.
