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SED Flow Control GmbH
Valves for Aseptic Applications

Valves for Aseptic Applications

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Valves for Aseptic Applications

Product catalog summary

Introduction and General Information

A Brief Overview: SED, established in 1984, specializes in valve technology and flow meters, focusing on aseptic diaphragm valves. The company prioritizes high-quality, reliable products through ongoing research and development.
The Company: SED employs modern machinery and facilities, including 3D-CAD-CAM networks and CNC machining, to ensure product quality and flexibility. Ergonomic workstations and clean room assembly are also emphasized.
Quality at SED: Quality is integral across all business areas, from R&D to customer service, with a focus on teamwork, continuous improvement, and strong supplier relationships.

Testing and Certification

Testing: Comprehensive testing includes valve assembly inspection, diaphragm valve seal tests, and non-destructive testing for media-contacted materials. Verification certificates are provided according to DIN EN 10204 standards.
Qualification and Certification: SED holds certifications such as ISO 9001 and ISO 14001, ensuring high-quality manufacturing processes.

Technical Specifications

Flow Rate and Valve Sizing: Conversion formulas for Kv to Cv values are provided, essential for designing valves based on required flow rates.
Surface Finish: Surface quality is crucial for aseptic processes, with mechanical and electro-polished finishes offered to enhance cleaning efficiency and reduce contamination risks.

Media Contacted Components

Diaphragms and Valve Bodies: Detailed specifications emphasize the importance of material quality and surface finish.

Aseptic Connections
This section covers components used for aseptic connections, including clamps, aseptic flanges, and threads, critical for maintaining sterile conditions in fluid handling systems.

Aseptic Diaphragm Valves
An overview of aseptic diaphragm valves highlights their importance in maintaining sterility, discussing the self-draining two-way valve design and innovative features of the new Type 905 valves. Manuals for both manual and pneumatically operated valves are included, along with ordering information.

Aseptic Diaphragm Valve Configurations
Various configurations such as D-Rule and welded valve configurations are discussed, explaining the benefits of multiport valves and providing specifications for tank valves.

Process Solutions
This part introduces sterile and purified steam sampling units, essential for ensuring the sterility of process solutions.

Angle Seat Valves
Describes the features and applications of angle seat valves, including technical data and ordering information.

System Components and Process Automation
An overview of system components and process automation is provided, including manual adjustments, electrical switch boxes, and detailed information on pilot valves and limit switches.

Diaphragms
The document emphasizes the importance of diaphragms in valve systems, detailing their certification and compliance with FDA and other standards. It discusses the traceability of diaphragms and the materials used, such as EPDM and PTFE, highlighting their properties and applications.

Valve Bodies
Information on the manufacturing processes of valve bodies, including forged, block, and investment cast bodies, is provided. The section also covers the chemical composition of materials used and the importance of adhering to international standards for tube ends.

Specifications
The document outlines various valve series, including 985, 995, and 997, and their corresponding dimensions and standards such as ISO 2852, DIN 32676, and ASME BPE. It provides detailed tables with measurements for different valve sizes and configurations.

Procedures and Standards
Key procedures include the assembly and maintenance of clamp connections, crucial for ensuring leak-proof and crevice-free joints. The document emphasizes the importance of aseptic connections, such as aseptic flanges and threads, for optimized cleaning and reduced contamination risks.

Recommendations
For optimal performance, the document recommends specific installation angles and slopes for valves to ensure complete drainability. It also highlights the benefits of modular valve construction for ease of maintenance and reduced complexity.

Key Features
The aseptic diaphragm valve is highlighted for its positive closure, suitability for CIP (Clean-in-Place) and SIP (Steam-in-Place) operations, and in-line maintenance capabilities. The document stresses the importance of a streamlined fluid passage and minimal contact surfaces to enhance cleaning and sterilization.

Conclusion
The document concludes with a focus on the importance of adhering to specified standards and recommendations to ensure the reliability and efficiency of aseptic diaphragm valves in industrial applications.

Overview
This document provides detailed technical specifications and features of SED's aseptic diaphragm valves, including the Steripur, KMA, and KMD series. It covers aspects such as valve design, materials, and operational capabilities, focusing on their suitability for sterile environments.

Specifications
The valves are available in various sizes and configurations, including manual and pneumatically operated options. Key specifications include:

Maximum working pressure: 10 bar (150 psi) for most types, with some variations.
Maximum working temperature: Up to 160°C (320°F), depending on the application and valve type.
Diaphragm materials: EPDM or PTFE.
Body materials: Forged or investment cast stainless steel (1.4435/316L ASME/BPE).
End connections: Butt weld ends, clamps, and flanges.

Design Features
The document highlights several innovative design features:

Compact Design: The valves are designed to minimize dead legs in process systems, with compact actuators that reduce space requirements.
CDSA Sealing Concept: This design ensures optimized internal cleaning and reduces product entrapment, enhancing sterility and cleaning efficiency.
Flexible Diaphragm Suspension: This feature helps distribute closing force evenly, extending diaphragm life and reducing the risk of leakage.
Encapsulated Diaphragm: Provides a positive visual appearance and reduces the risk of external leakage.

Performance and Applications
The valves are suitable for various applications, including two-way bodies, welded configurations, T-bodies, multiport bodies, and tank bottom bodies. They are designed for easy maintenance and assembly, with features like bottom entry assembly and through bolt hole actuator assembly.

Conclusion
SED's aseptic diaphragm valves offer a range of features and configurations to meet the needs of sterile processing environments. Their innovative designs focus on minimizing contamination risks and improving cleaning efficiency, making them suitable for high-demand applications in industries requiring stringent hygiene standards.

Overview: The document provides detailed technical specifications and features of various manual and pneumatically operated diaphragm valves, suitable for different applications and sizes ranging from DN 4 to DN 100 mm. It includes information on materials, pressure and temperature limits, and optional features.

Manual Valves:

Specifications: Available in sizes DN 15 - 100 mm, with a maximum working pressure of 10 bar (150 psi) and temperature up to 160°C (320°F) depending on the application. Diaphragm materials include EPDM or PTFE, and valve bodies are made from forged or investment cast 1.4435/316L stainless steel.
Features: Stainless steel bonnet, plastic hand wheel, rising or non-rising hand wheel with optical indicator, sealed bonnet, and flexible diaphragm suspension. Optional features include adjustable stroke limiter and U-Lock for hand wheel.

Pneumatically Operated Valves:

Specifications: Sizes range from DN 4 to DN 100 mm. Control functions include fail-safe close, fail-safe open, and double acting. Maximum working pressure varies with diaphragm material, with EPDM at 8 bar (115 psi) and PTFE at 7 bar (100 psi). Maximum temperature is 160°C (320°F).
Features: High cycle stainless steel or plastic piston actuators, compact design, flexible diaphragm suspension, encapsulated diaphragm, and CDSA sealing concept. Optional features include a wide range of control equipment and accessories, and autoclavable options.

Common Features: Both manual and pneumatically operated valves feature butt weld ends, with options for clamps and flanges. They are designed for various configurations including two-way, T-bodies, multiport, and tank bottom bodies.

Additional Information: The document references additional pages for detailed diagrams, flow rates, and sealing concepts. It also provides links to the manufacturer's website for further resources and introduction videos.

Overview
This document provides detailed specifications and technical data for various pneumatically operated valves manufactured by SED Flow Control. The valves are designed for different applications, featuring various actuator types and configurations.

Valve Types and Features

Steripur 407: Features a high cycle stainless steel piston actuator, compact design, and CDSA sealing concept. It is suitable for sterile wash downs and offers optional control equipment and accessories.
KMA 495: Equipped with a plastic diaphragm actuator and stainless steel distance piece. It offers a flexible diaphragm suspension and is available with various control equipment.
KMA 395: Features a plastic piston actuator with a compact design and high resistance to heat transfer. It includes a CDSA sealing concept and is suitable for wash downs.
KMD 385: This valve has a plastic diaphragm actuator directly assembled with the valve body, offering high resistance to heat transfer and a smooth exterior design.
KMD 402: Features a plastic piston actuator with a compact design and high resistance to heat transfer, suitable for wash downs.
Steripur 392: A two-stage stainless steel actuator with adjustable flow for filling, ideal for sterile wash downs.
Steripur 592: Similar to Steripur 392, with additional features for multiport bodies and manifold valve assemblies.

Technical Specifications

Control Functions: Various configurations including fail-safe close (NC), fail-safe open (NO), and double acting (DA).
Pressure and Temperature: Maximum working pressure and temperature vary by valve type and diaphragm material, with EPDM and PTFE options available.
Materials: Valve bodies are made from forged or investment cast 1.4435/316 L stainless steel, with other alloys available.
End Connections: Options include butt weld ends, clamps, flanges, and special ends for different configurations.

Dimensions and Weight
The document provides detailed dimensions and weight for each valve type, with specific measurements for different DN sizes.

Ordering Information
An ordering key is provided to specify the type, size, valve body material, end connection, diaphragm material, actuator control function, actuator type, and surface roughness.

Additional Notes
Higher working pressures may be achieved with different actuators, and consultation with a SED factory representative is recommended for pressures above the indicated maximum.

Introduction
This document provides a comprehensive overview of the KMD Series valves, focusing on stainless steel adaptations, plastic actuators, and various configurations for aseptic diaphragm valves. It includes specifications, procedures, and recommendations for valve selection and installation.

Specifications

Valve Sizes: Available in sizes DN 4 to DN 100.
Valve Body Material: Options include stainless steel (investment cast and forged) and Hastelloy.
End Connections: Various butt weld tube end connections are available, compliant with standards such as DIN, EN ISO, ASME BPE, and others.
Diaphragm Material: Options include EPDM and PTFE/EPDM, all FDA/USP compliant.
Actuator Control Functions: Includes manually operated, normally closed (NC), normally open (NO), and double-acting (DA) configurations.
Surface Roughness: Internal surfaces are mechanically polished with options for electropolishing, adhering to ASME BPE standards.

Procedures and Standards

Testing and Certification: The document outlines testing procedures and certification requirements for quality assurance.
Flow Rate and Valve Sizing: Guidelines for determining appropriate valve sizes based on flow rate requirements.
Surface Finish: Detailed specifications for surface roughness to ensure compliance with industry standards.

Recommendations

Welded Valve Configurations: Recommended for reducing dead legs and improving drainability in aseptic processes.
Multiport Valves: Suggested for optimizing process purity and efficiency, with customizable designs to meet specific process needs.

Ordering Information
The document provides an ordering key and examples to assist in specifying the correct valve configurations, including actuator type, control function, and material specifications.

Conclusion
This manual serves as a detailed guide for selecting and configuring KMD Series valves, emphasizing the importance of adhering to industry standards and best practices for aseptic processing.

Overview
This document provides detailed information on various valve configurations and their applications in aseptic processes. It includes specifications for tank valves, sampling units, and angle seat valves, highlighting their features, applications, and technical data.

Tank Valves
The document describes different tank valve configurations, including main valves and sample valves with options for right and left side outlets. These valves are designed to be fully drainable and are rotated into a self-draining position to avoid interference with the tank bottom.

Sterile Sampling Unit
The sterile sampling unit is designed for taking sterile samples from liquids in aseptic processes. It features an integral valve unit, CIP/SIP function, and is autoclavable. The unit is compact, efficient in sterilization, and offers material traceability. Recommendations include having multiple units for continuous sampling and cleaning cycles.

Purified Steam Sampling Unit
This unit includes a cooling coil with an integrated valve for sampling. It allows for temperature control of the purified steam condensate and is designed for easy sterilization. The unit is made of high-grade stainless steel and is suitable for both permanent and mobile use.

Angle Seat Valves
The SED Angle Seat Valve is a 2/2-way valve with a pneumatically operated piston actuator. It is suitable for various industries, including pharmaceutical and food, and is used for applications like sterilization, cooling circuits, and process flow control. The valve features high flow rates, adjustable actuator orientation, and a variety of end connections.

Technical Data
The document provides technical specifications for the valves, including working pressure, temperature ranges, and material compatibility. It also includes ordering keys and examples for selecting the appropriate valve configurations based on specific requirements.

Technical Specifications:
The document outlines the technical specifications for process automation components, including material housing made of stainless steel, mechanical adaptation options, ambient temperature range (-10°C to +70°C), maximum pressure (8 bar), power supply (24V DC +/- 10%), power consumption (0.7 W), and electrical connection (Multipol M12, 5 Pin, A-coded). The protection class is IP67 according to EN 60529, and conformity is according to CE EMV-9/336/EWG.

Features and Functionality:
The SED electrical control head is designed for ease of assembly with linear valves and includes features such as self-positioning, optical position feedback, and contact-free limit switches. It offers position feedback versions with electromechanical switches, inductive initiators, and AS-Interface. Optional features include an integral solenoid valve and stroke limiter.

Control Head and Positioners:
The document describes various control head versions and electropneumatic positioners, highlighting their compact design, ease of start-up, and high air flow rate. The positioners are suitable for single and double-acting actuators and offer options for analogue position feedback and process control.

Standards and Compliance:
The document references various standards and compliance requirements, including those from ASME, ASTM, CEN, DIN, and FDA. It also includes a glossary of terms related to process automation and standards.

Additional Information:
Contact information for SED Flow Control GmbH is provided, along with links to their website and product configurator for further details and product configuration options.

Catalog excerpts

Aseptic Applications Pharmaceutical Project Filtration Skid Blood seperation skid Fermentation Plan Biopharm Project

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What does Quality mean at SED? General Information Qualification, Certification and Documentation Flow Rate and Valve Sizing Surface Finish Media Contacted Components Valve Bodies (fold out page) 18 Butt Weld Tube Ends (fold out page) 19 Aseptic Connections Aseptic Flanges and Aseptic Threads 21 Aseptic Diaphragm Valves Overview Diaphragm Aseptic Valves 24 - 25 Why Aseptic Diaphragm Valve? 26 Self Draining - Two-Way Valve 27 Aseptic Diaphragm Valves New Type 905 Aseptic Diaphragm Valve Manual 32 - 41 Aseptic Diaphragm Valve Pneumatically Operated 42 - 55 Ordering Key and Ordering Example 56,...

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A Brief Overview SED was founded in 1984 and is engaged in the development, manufacture and distribution of sophisticated valve technology and ow meters. The aseptic diaphragm valve and all the corresponding components is the main focus of SED. With more than 20 years of experience, continuous research and development guarantees that our products are of the highest quality and reliability in all process applications. The ofce building is connected to the production building for direct communication with manufacturing. The SED versatile and comprehensive product offering provides many advantages...

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Introduction and General Information The company has installed the most modern machinery and individual production facilities which are fully adapted to current market requirements. • The 3D-CAD-CAM network connects CAD- CAM working station all the CAD workstations with the 3 and 5 axis CNC machining facilities, bringing our products from conception to development. • Injection molding manufacturing, special injection molding machines, and tools adapted to high performance plastics and specic processes. • Assembly in clean room facilities with ultrasonic clean washing including other automated...

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What Does Quality Mean at SED? The complete satisfaction of our customer is our ultimate benchmark for quality. Only then, may a successful and sustained existence in the market be guaranteed. The prerequisite for quality is not only a functional product but also that the quality concept is applied comprehensively to all areas of our business. This includes research and development, production, suppliers, services and our sales team. The Fundamental Areas of Our Quality Policy: Spectrometer for material analysis Products and Services: An accelerated implementation of customized solutions is achieved...

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Introduction and General Information Testing Complete Valve Assembly Inspection • 100% according to checklist Diaphragm Valve Seal Test • Test according to DIN EN 12266-1 • 100% valve assemblies seal tested Internal Surface Finish • 100% visual inspection • Prolometer inspection as per specication Weld Seam Testing Borescope inspection of the interior surface and weld seams of valves for aseptic applications • 100% visual inspection • 100% borescope inspection of all weld seams not directly visible with the eye or as per specication 100% pressure testing • Non-Destructive Testing for media contacted...

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Qualication, Certication and Documentation Certied Process Qualication • Quality Management System ISO 9001 • Environment Management System ISO 14001 • Manufacturing Process HP0 AD2000 • Pressure Equipment Directive 97/23 EC • Specialised Company for Welding ISO 3834-2 • Qualied Personnel for Material Traceability according §2 Abs.2a Gerätesicherungsgesetz Validation for the Aseptic Diaphragm Valve • Compliance to 3-A Standard Section 54-02 • Compliance of SED CDSA Design to EHEDG Hygienic Equipment Design Criteria Document No.8SED CDSA • Compliance to CRN Canadian Standards Association • Certication...

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Conversion: For the correct Kv to Cv conversion calculation, use only the stated units formulas below. The Kv-value must be converted from (cubic meter / hour) by utilizing the following conversion factors. In the US the ow rate of water is measured with the Cv-value in US-gallons per minute (gpm) with a pressure drop of ∆p 1 PSI. Kv-value The Kv-value is a parameter dening the ow rate of valves. It describes the amount of water from 5° to 30°C which ows through the valve at a pressure loss of 1 bar. The Kvs-value describes the Kv-value when the valve is 100% open. General Liquid Flow Formula:...

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Surface Finish The consistency of the interior surface has a great impact on the quality of an aseptic system process. By means of polishing, the interior contact surface is reduced. The specied surface quality of the valve body is achieved through mechanical polishing and electro polishing. According to the standards SED offers surfaces with a surface nish up to a quality of 0,25 μm and 10 Ra. At SED the stated surface nish always describes the maximum surface roughness value. The surface nish is reached by automatic or manual mechanical polish processing. The methods that are applied depend...

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Surface Finish The arithmetic average Ra is used as parameter for the surface finish profile. I_t = 5,6 mm traversing length/measuring range - 5 single measuring length Lc = 0,8 mm each are measured transverse to the polished image. Definition of the SED codes for Ra-Values Tape Print Out of Surface Finish

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A Brief Overview The Company What does Quality mean at SED? General Information Testing Qualication, Certication and Documentation Flow Rate and Valve Sizing Surface Finish Media Contacted Components Diaphragms Valve Bodies (fold out page) Butt Weld Tube Ends (fold out page) Aseptic Connections Clamps Aseptic Flanges and Aseptic Threads Media Contacted Components Aseptic Diaphragm Valves Overview Diaphragm Aseptic Valves Why Aseptic Diaphragm Valve? Self Draining - Two-Way Valve Innovative Design Aseptic Diaphragm Valves New Type 905 Aseptic Diaphragm Valve Manual Aseptic Diaphragm Valve Pneumatically...

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