ASME BPE - Ensuring superior quality in bioprocessing equipment

By following the stringent demands of ASME-BPE, it is possible to achieve more efficient production rates, lower costs for manufacturing and development and improved levels of quality and safety. 

Understanding ASME BPE 

The ASME BPE standard includes a wide range of components, including ASME BPE fittings, flanges, pipes, gaskets, and tubes, each made to meet stringent requirements. This standard is not only a set of guidelines but a comprehensive system that includes material properties, selection, surface finish, design criteria, fabrication, welding, documentation, certification, inspection, testing, dimensions, tolerances, process instrumentation, sterility, cleanability, modularity, and adaptability. 

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Material properties and selection 

At the heart of ASME BPE is the emphasis on material properties and selection. Materials used in bioprocessing equipment must withstand the rigors of sterilization processes and exposure to various chemicals without degradation. The selection process involves careful consideration of the material's corrosion resistance, durability, and compatibility with the products processed. Mainly is used the alloy 316 and 316L but alloy 304 and 304L can also be used.  

Surface finish 

The surface finish of components like ASME BPE pipes and tubes is crucial in bioprocessing applications. A smooth surface finish minimizes the risk of contamination and facilitates easier cleaning and sterilization, thereby maintaining the sterility and integrity of the process. 

At Alfa Laval we offer SF1 (Mechanically Polished Surface Finish) and SF4 (Electropolished Surface Finish) 

SF1: Mechanically Polished Surface Finish 

• This is the smoothest finish and is often used in critical applications where cleanliness and sterility are paramount. 
• The surface roughness will have a Ra value of maximum 0.51 µm. 

SF4: Electropolished Surface Finish 

• Electropolishing is a chemical process that smoothens and passivates the surface of stainless steel. 
• The surface roughness is less than 0.38 µm Ra. 

Design criteria 

The design of ASME BPE components, including fittings and flanges, follows specific criteria that ensure safety, reliability, and efficiency. This involves considering factors like flow characteristics, ease of assembly, and maintenance requirements. 

Documentation and certification 

ASME BPE demands comprehensive documentation and certification for all components. This includes detailed records of the materials, production processes, and testing procedures used, ensuring traceability and compliance with the standard. 

Alfa Laval documentation includes the most recent documents developed by the ASME organization together with MTR/3.1 for full traceability. Our ASME BPE are laser marked with the following information*: 

• ASME Certification Mark with BPE Designator
• Surface designation SF1 to SF4 
• Dimension
• Material
• Heat number 

*On smaller items, limited space may result in reduced information.

The production and welding processes for ASME BPE equipment are meticulously controlled. These processes must ensure that the final components maintains the material properties and surface integrity required for bioprocessing applications. 

Regular inspection and testing are critical to maintaining the standard's integrity. This includes both in-process inspections and final testing to verify that all components meet the specified requirements. 

Precision in dimensions and tolerances is key for the compatibility and interchangeability of ASME BPE components. This ensures that parts fit together seamlessly, reducing the risk of leaks or contamination. 

The standard extends to name the different tools for measuring the quality of the stainless steel and the tubes and fittings. This is called process instrumentation. Ensuring that it provides accurate and reliable measurements crucial for process control and quality assurance. The process instrumentation includes measurement devices, control systems, monitoring and data acquisition, compliance, design, calibration, and validation.  

ASME BPE equipment is designed with sterility and cleanability in mind. This is essential in preventing microbial growth and cross-contamination, which are critical concerns in bioprocessing. 

The standard encourages modularity and adaptability in the design of bioprocessing equipment. This allows for flexible configurations and easy upgrades to accommodate changing process needs. 

Alfa Laval' role and contribution 

Alfa Laval's involvement in the ASME committee underlines our commitment to these standards. As a certified entity, we not only comply with but actively contribute to the development of the ASME BPE standard. Our expertise in handling issues in cooperation with our customers contributes to the continuous development of the standard, ensuring it remains relevant and effective in addressing the changing needs of the bioprocessing industry. 

DISCLAIMER

This webpage contains information about the condition and/or usability of materials and/or products but offers no warranty for their properties. The webpage is for information purposes only. The information provided is given for your advice and complies with our experiences and information provided by our suppliers. Alfa Laval does not give any warranty on the information provided. Please contact your local sales office for additional information.