Valves for Aseptic Applications
112Pages

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

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...

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...

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...

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...

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...

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 •...

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...

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...

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

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...

Diaphragms Certication and Compliance for Validation At SED, we recognize the importance of the validation process in the aseptic industry. This has led to an internal awareness and specic restructuring within the company to provide the highest level of reliability and regulatory compliance through the complete supply chain to provide a complete package of documentation for all components in contact with the process uid. Related to it the key performance component in the diaphragm valve is the diaphragm. • All resin and additives used in the manufacturing process are FDA compliant. •...