Introduction and Context

The document details the VESTA Multiport valve block system by Tuchenhagen, engineered for pharmaceutical and biotech industries. It addresses the need for reliable, sterile valve technology compliant with FDA, cGMP, and other regulations, supporting complex production processes involving sterilization and cleaning.

Challenges with Conventional Valve Systems

• Traditional individual valve assemblies are labor-intensive, require large spacing, and create dead spaces that are hard to clean.
• Membrane valve blocks in rigid casings reduce dead spaces but have limitations such as incomplete vacuum capability and slow sterilization heating due to thick walls.

VESTA Multiport Valve Block Overview

The VESTA Multiport valve block features a ring-shaped design eliminating dead spaces, enabling full vacuum capability, and meeting CIP (Clean-In-Place) standards. It is compact, cost-effective, and easily integrated into process systems.

Design Features

• Ring distributor with channel cross-section about 50% of valve outlet size.
• Valves mounted on the ring’s end face, typically installed horizontally with vertical actuators.
• Modular and compact structure comprising mainly the ring distributor and valve body.
• Flow shut-off integrated within the ring circuit.
• Customizable configurations with up to 12 valves per ring (6 internal, 6 return lines).
• Fixed grids and fully drainable system optimized for CIP/SIP.
• Use of sterile valve-compatible actuators.
• Simple, reliable operation and maintenance.

Valve Configuration and Flexibility

The system supports mixing valves of different sizes and thicknesses on the same ring, allowing tailored solutions. A configuration library with pictograms aids design selection.

Materials and Surface Quality

• Product-contact parts made from stainless steel 1.4435 / AISI 316L with delta ferrite <1%.
• PTFE TFM 1705 bellows compliant with FDA and USP Class VI biocompatibility.
• Actuators constructed from stainless steel 1.4301 / AISI 304 or PPS plastic.
• Internal surface finish standard Ra ≤ 0.8 μm, optionally Ra ≤ 0.4 μm via electropolishing.
• External surfaces are rolled stainless steel or treated plastic per VDI 3400 standards.
• High-quality TIG automatic welding on product-contact surfaces.
• Hydrophobic external ring surface to maintain hygiene over time.

Dimensions and Standards

• Compatible with DIN 11850, DIN 11866, ISO 1127, ASME BPE 2002 pipe standards.
• Nominal pipe sizes from DN 15 to DN 33.7 with various wall thicknesses; custom sizes available.

Operation and Maintenance

• Designed for quick, simple installation and servicing.
• Valve cores removable by loosening spline nuts without special tools, even in confined spaces.
• No sliding fittings on valve cores, enhancing reliability.

Quality Assurance and Certification

• Manufactured under DIN ISO 9001 quality management system.
• Quality controls include part marking, functional testing, and seal inspections.
• Material certificates per EN 10204 / 3.1 available on request.
• Documentation of surface roughness and delta ferrite content provided.
• Weld seam certification compliant with cGMP standards.
• Qualification and validation (DQ/IQ/OQ) can be performed at manufacturing site to ease customer acceptance.

Technical Specifications

• Maximum working pressure: up to 6 bar (temperature-dependent).
• Air control pressure for actuators: NC type 5-10 bar, NO type 5-6 bar.
• Maximum working temperature: up to 135°C (pressure-dependent).
• Sterilization temperature: up to 150°C.

Application Examples

Examples include star-shaped horizontal piping with valves on inlet and outlet lines. Detailed specifications cover valve sizes, nominal connections, flow directions, actuator types, and cleaning paths tailored to specific layouts.

Summary of Benefits

• Elimination of dead space and full vacuum capability enhance hygiene and process efficiency.
• Compact modular design reduces installation footprint and time.
• Customizable valve configurations adapt to diverse process needs.
• High-quality materials and surface finishes ensure pharmaceutical compliance.
• Easy maintenance reduces downtime and operational costs.
• Comprehensive quality assurance and documentation support regulatory compliance.

Overview of VESTA Multiport Valve System

The system supports complex sterilization, cleaning, and product transfer processes, handling multiple media without cross-contamination and ensuring efficient operation.

Key Specifications and Features

• Media: Drinking water, caustic solution at 80°C, demineralized water, high purity steam, sterile air.
• Pipeline Design: Product and media pipelines require a 2% slope for proper drainage.
• Valve Blocks: Various ring valve block types (HVA-6/6, HVA-5/3, etc.) used for tanks and cleaning columns.
• Surface Quality: Standard Ra ≤ 0.8 μm with electropolishing; optional Ra ≤ 0.4 μm.
• Material: Stainless steel 1.4435 with ΔFe < 1%; other materials on request.
• Valve Actuators: Pneumatic drives (plastic or stainless steel), NC or NO, manual plastic drives, plus auxiliary devices like non-contact switches and limiters.

Operational and Design Recommendations

• Intermediate cleaning after each product change to prevent contamination.
• Ensure reliable emptying to avoid product loss.
• Avoid dead ends and product losses in pipeline design.
• Special cleaning columns designed for up to five small containers.
• Use of small mobile tanks for washing, cleaning, and sterilization.

Engineering Concepts and Applications

The modular valve blocks enable flexible configurations for batch preparation with tanks equipped with agitators and cleaning columns. Flow direction and grid placement are optimized to prevent dead zones and ensure complete drainage.

Ordering and Specification Process

Customers provide detailed operational parameters, materials, surface quality, and configuration needs via a questionnaire form including abbreviations for valve seat locations, grid sizes, actuator types, and auxiliary devices. Tuchenhagen offers free proposals with pricing, specifications, and dimensional drawings upon receipt of detailed data.

Summary of Abbreviations and Codes

• Valve Seat Positions: S (star), HN/HS/HW/HO (horizontal north/south/west/east), VN/VS/VW/VO (vertical north/south/west/east).
• Grid Sizes: R1 = 90 mm standard, R2 = 120 mm for insulated pipes.
• Actuator Types: PZ/PA (plastic pneumatic NC/NO), MZ/MA (stainless steel pneumatic NC/NO), H (manual plastic), M (non-contact switch), B (control block), 20/21 (open/close limiters).

Technical Data Summary

• Working pressure and media temperature specified by customer.
• Sterilization temperature specified by customer.
• Nominal connection size: ISO 33.7 mm standard.

Contact Information

Manufacturer: Tuchenhagen GmbH, part of GEA Group, located in Bopfingen and Büchen, Germany. Contact via telephone, fax, email, and website for inquiries and orders.