Valves for Aseptic Applications
124Pages

Valves for aseptic Applications SMART IN FLOW CONTROL.

Aseptic Applications Pharmaceutical Project Filtration Skid Human blood fractionation Bioreactor Skid Biopharm Project

Page A Brief Overview 4 Company 5 The What does Quality mean at SED? 6 Introduction and General Information General Information Testing 7 Qualification, Certification and Documentation 8 Flow Rate and Valve Sizing 9 Surface Finish 10, 11 Media Contacted Components Diaphragms 14 - 19 Bodies (fold out page) 20 Valve Butt Weld Tube Ends (fold out page) 21 Aseptic Connections Clamps 22 Aseptic Flanges and Aseptic Threads 23 Aseptic Diaphragm Valves Overview Diaphragm Aseptic Valves 26, 27 Why Aseptic Diaphragm Valve? 28 Draining - Two-Way Valve 29 Self Innovative Design 30 - 33 Aseptic...

A Brief Overview SED was founded in 1984 and is engaged in the development, manufacture and distribution of sophisticated valve technology and flow 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 office building is connected to the production building for direct communication with manufacturing. The SED versatile and comprehensive product offering provides many...

Introduction and General Information The company has installed the most modern machinery and individual production facilities which are fully adapted to current market requirements. Specifically: • 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 specific processes. • Assembly in clean room facilities with ultrasonic clean washing...

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 and RFA material analysis An accelerated implementation of customized solutions is achieved with...

Introduction and General Information Testing Complete Valve Assembly Inspection Diaphragm Valve Seal Test • Test according to DIN EN 12266-1 • 100% valve assemblies seal tested Internal Surface Finish • 100% visual inspection • Profilometer inspection as per specification 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 specification 100% pressure testing • Non-Destructive Testing for media contacted body material...

• Quality Management System ISO 9001 • Environment Management System ISO 14001 • Energy Management System ISO 50001 • Manufacturing Process AD2000 Merkblatt HP0 • Pressure Equipment Directive 2014/68/EU • Specialised Company for Welding ISO 3834-2 • Qualified Personnel for Material Traceability according §2 Abs.2a Geratesicherungsgesetz • ATEX Directive 2014/34/EU _ 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...

In order to design valves for a process system correctly, the valve size is determined by the required flow rate. The Kv-value serves as a calculation basis for the different process conditions. This value is stated in the following table with regard to nominal diameter and standards. Kv-value The Kv-value is a parameter defining the flow rate of valves. It describes the amount of water from 5° to 30°C which flows through the valve at a pressure loss of 1 bar. The Kvs-value describes the Kv-value when the valve is 100% open. 73 .2 C m (0 ™ I O -t-J 4-o c D “ "5 ® O i-Conversion: For the...

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 specified surface quality of the valve body is achieved through mechanical polishing and electro polishing. According to the standards SED offers surfaces with a surface finish up to a quality of 0,25 µm and 10 Ra. At SED the stated surface finish always describes the maximum surface roughness value. The surface finish is reached by automatic or manual mechanical polish processing. The methods that are...

Ra-Value The arithmetic average Ra is used as parameter for the surface finish profile. L t = 5,6 mm traversing length and l n = 4,0 mm measuring range split in 5 single measuring sections l r = 0,8 mm each measured transverse to the polished image. Definition of the SED codes for Ra-Values

Page A Brief Overview 4 Company 5 The What does Quality mean at SED? 6 Media Contacted Components General Information Testing 7 Qualification, Certification and Documentation 8 Flow Rate and Valve Sizing 9 Surface Finish 10, 11 Media Contacted Components Diaphragms 14 - 19 Bodies (fold out page) 20 Valve Butt Weld Tube Ends (fold out page) 21 Aseptic Connections Clamps 22 Aseptic Flanges and Aseptic Threads 23 Aseptic Diaphragm Valves Overview Diaphragm Aseptic Valves 26, 27 Why Aseptic Diaphragm Valve? 28 Draining - Two-Way Valve 29 Self Innovative Design 30 - 33 Aseptic Diaphragm Valves...

The diaphragm is the most important component of the diaphragm valve. Besides the valve body, the diaphragm is the only part which contacts the process medium. The diaphragm separates the process medium from the actuator or top works and the external atmosphere. In addition the diaphragm is the dynamic part which the flow rate of the process medium is controlled and stopped. The developing of formulation of compound is done closely with a specialised company developing, producing and testing compounds since many years together with SED for our market. The SED diaphragms have been developed...