Diaphragm valve

manualfor the pharmaceutical industrymetal

Overview
For modern substance manufacturing facilities in the pharmaceutical industry, SISTO (SISTO Armaturen), together with parent company KSB SE & Co. KGaA, produces diaphragm valve bodies using metal additive manufacturing (metal 3D printing). This approach enables production from metal powder when forged stock is unavailable, improving material availability and delivery times while allowing tailored material choices for high-strength applications.

Key benefits and rationale
Additive manufacturing enables production of valve body components from metal powder rather than relying on forged blocks, addressing raw-material shortages and long lead times while enabling new geometries and potential weight savings.

Advantages of Additive Manufacturing

• Greater availability: Production from metal powder improves material availability and shortens delivery times.
• High flexibility: Freedom from the geometrical limits of forged stock allows complex geometries and faster engineering cycles, reducing project duration.
• Higher material homogeneity: Additively produced raw parts show improved homogeneity compared with forged components.
• Unaltered quality: Additively manufactured parts undergo the same quality inspections as conventionally manufactured parts; each production batch is tested and monitored.
• Light and space-efficient: Material is added only where required, resulting in significantly lighter diaphragm valve bodies.
• Compliance with Pressure Equipment Directive: Suitability of 3D-print materials was tested and documented with involvement of TÜV Rheinland; additively manufactured diaphragm valves meet PED 2014/68/EU requirements.

Quality standards and testing
Material compliance and production parameters for additive manufacturing were verified and documented by SISTO with involvement of TÜV Rheinland. Production is TÜV-certified; physical parameters of all melted parts are continuously monitored and recorded. The quality level is equivalent to comparable forged diaphragm valve components.

Design and future outlook
SISTO emphasises the new design possibilities of additive manufacturing by building material only where needed. The company expects additive processes to become faster and more efficient and foresees growing demand for customised diaphragm valve solutions, with ongoing investment in R&D.

Technical characteristics / specifications

• Product type: Additive-manufactured diaphragm valve components (metal 3D printing)
• Primary materials: Metal powder, e.g. high-quality nickel-based alloys
• Manufacturing advantages: Reduced lead times, lighter valve bodies, increased design freedom
• Material properties: Improved homogeneity versus forged components
• Quality control: Batch testing; continuous monitoring of physical parameters of melted parts
• Certification / compliance: Tested and documented with TÜV Rheinland involvement; meets Pressure Equipment Directive (PED) 2014/68/EU
• Intended industries: Pharmaceutical and biotech substance manufacturing facilities