ASME BPE – the global standard for aseptic piping systems.
09 juli 2025
In the pharmaceutical and biotechnological industries, everything revolves around control, purity and reliability. The ASME BPE standard (Bioprocessing Equipment) is the global benchmark for the design, manufacture and application of piping systems in aseptic environments. This standard sets exceptionally high requirements for surface finish, dimensional accuracy, cleanability and full traceability of components. At Rodesta, we supply ASME BPE certified tubes and fittings that meet the most stringent criteria – for a safe, validated and future-proof production process.
What is ASME BPE?
ASME BPE is an internationally recognized standard developed by the American Society of Mechanical Engineers. This standard is fully tailored to the requirements of the biopharmaceutical industry and covers all aspects of piping systems, from raw material to end use. Topics such as surface finish, weldability, corrosion resistance, material specifications and inspection are described in detail.
The standard applies to environments where any form of contamination or irregularity can directly impact the safety, efficacy and reproducibility of the final product. ASME BPE is therefore indispensable for manufacturers operating under GMP, FDA or USP guidelines.
Key features of ASME BPE components
Ultra-smooth internal surface finish for optimal aseptic processes:
A core requirement of ASME BPE is the internal surface finish of tubes and fittings. A low Ra value (surface roughness) prevents product buildup, biofilm formation and microbial contamination.
Rodesta supplies components with the following surface finishes:
- SF1: mechanically polished (Ra ≤ 0.51 µm)
- SF4: electropolished (Ra ≤ 0.38 µm)
Both finishes are part of a validated SIP/CIP process and are visually and metrologically inspected.
Materials suitable for pharmaceutical and biotechnological processes
The selection of the right material is essential. We supply high-grade stainless steels with excellent corrosion resistance that meet the strict requirements of pharmaceutical and biotechnological applications:
- 1.4404 (316L): widely used for its low carbon content and broad applicability
- 1.4435: with extra-low delta ferrite and low sulfur content (0.005 – 0.017%), often specified as BN2-grade for sensitive processes
Other grades are available on request, including materials with delta ferrite control, specific ferrite limits or PMP-tested batches.
Precise tolerances and perfect compatibility
ASME BPE prescribes strict tolerances, defined in Part DT of the standard. Components are available in a wide range of imperial dimensions from 1/4" x 0.035" to 6" x 0.109" (6.35 mm x 0.89 mm to 152.4 mm x 2.77 mm). Thanks to this standardization, all parts fit together perfectly – regardless of manufacturer or production batch. This prevents waste, speeds up assembly and increases system reliability.
Cleaning and packaging according to pharmaceutical standards
ASME BPE components from Rodesta are thoroughly cleaned and packaged under controlled conditions. All tubes and fittings are:
- Free from oil, grease and particles: according to CGA G-4.1:2018 and ASTM G93 – level C or B
- Standard packed in protective foil or double packaging: suitable for cleanroom environments
On request, we supply components that can be used directly in cleanrooms – without additional cleaning or reprocessing.
Full documentation and traceability
Each delivery of ASME BPE components includes:
- EN 10204 3.1 certificates
- Surface roughness reports
- Batch number on each product: laser or electro marked
- Optional: welding documentation, validation information, USP Class VI statements
This complete documentation makes it easy for you to comply with audits, quality assurance processes and validation requirements.
Rodesta – your partner in aseptic piping
At Rodesta, we combine technical expertise with high-quality products. Whether you are expanding an existing installation or setting up a completely new cleanroom line – we think along with you. Our ASME BPE components are available from stock or supplied project-based, according to your specific needs. We also provide support in selection, documentation and validation.
Looking for ASME BPE components that are optimally suited to your pharmaceutical process?
Contact us for technical advice, price lists or customized documentation.
sales@rodesta.com
