Your Specialist and Partner in the Field of Pharmaceutical Applications

Transcription

1 Your Specialist and Partner in the Field of Pharmaceutical Applications

2 Pressure Reducer We reserve the right to make technical changes. Images non-binding. 08/2014 CrNiMo stainless steel (1.4435*), deep-drawn, corrosion-resistant, lightweight and compact long operational lifespan, easy installation, minimum space required, low delta ferrite content possible 1 minimum mass low thermal losses during CIP/SIP applications, shorter cleaning and sterilisation times 2 external standard surface Ra 1.6 μm, optionally electropolished, fine quality micro-blasted up to 0.4 μm easy-to-clean non-rising adjusting screw (optional protection against misplacement) unchanged overall height, function visible externally leakage line connection and adjusting screw seal (option) can be used for flammable and dangerous media according to UVV regulations 7 pressure pipe connection automated CIP / SIP processes 8 connection: DIN, ISO or TRI-CLAMP, aseptic flanges, weld-on ends... various flexible connections possible Internal Parts compliance with FDA USP Class VI 121 C approved for pharmaceutical and food processing plants 4 PTFE protecting foil Mankenberg clamp system easy-to-maintain 4 physiologically unobjectionable, can be exposed to steam in a temperature range up to 180 C angle valve, virtually no dead pockets 5 internal surface standard up to Ra 0.25 μm, mechanically polished, electropolished also usable for highly viscous media compliance to the highest hygiene standards Pressure Reducing Valve Hygienic Class HE5 DM 152 single-seat, angled design suitable for small and medium flow rates usable for liquids, gases and steam completely made of deep-drawn CrNiMo-steel (1.4435*) surface finish possible up to Ra 0.25 μm hygienic class HE5 virtually pocket-free, is corrosion-resistant, lightweight and compact elastomers as per FDA and USP Class VI reduced preheating time for CIP/SIP procedures, less energy needed adjusting screw as a function of display easy-to-maintain owing to the clamp system TRI-CLAMP connections or DIN/ISO clamp connections can be actuated pneumatically, spring cap available with leakage line connection and adjusting screw seal DN PN T 130 C / 180 C bar K VS 2-7 m 3 /h

3 Extract from the Variety of our Valves for Pharmaceutical Applications Reducing the Sterile Air Pressure in an Ampoule Filling Machine The pharmaceutical industry has particularly high requirements with regard to purity and safety of the plants. Microbial contamination must be reliably excluded during any phase of production and packing. Consequently, ampoules and small volume containers are sterilised and filled while exposed to a controlled directed flow of sterile air. By excluding non-sterile external air from this process, the ampoules and containers can be reliably kept germ-free and protected from recontamination by microorganisms until they are closed. In a filling and packaging plant for ampoules in Belgium the sterile air is made available at a central place and then distributed through pipelines. The pressure reducing valve DM 505 reduces the sterile air pressure to the corresponding pressure required directly at the consumer, i.e. the filling and packaging plant. The single-seated and diaphragm-operated pressure reducing valve is designed for a temperature range of -35 C through to +130 C and reduces the outlet pressure to bar. The elastomers which come into contact with the medium are in compliance with the FDA and USP Class VI rules and regulations. The valve s inlet and outlet sides are equipped with aseptic TRI-CLAMP pipe joints. Pressure Reducing Valve Hygienic Class HE3 DM 505 single-seat straight-way valve, inlet pressure up to 250 bar, also controls millibar ranges usable for liquids and gases completely made of deep-drawn CrNiMo-steel (1.4435*) surface finish of the body Ra 1.6 μm hygienic class HE3 adjusting screw as a function of display easy-to-maintain owing to the clamp system corrosion-resistant, very lightweight and compact long operational lifespan manageable installation, various designs and connection types TRI-CLAMP connections or DIN/ISO clamp connections can be actuated pneumatically spring cap available with leakage line connection and adjusting screw seal DN PN G / NPT 1/₂ - 1 T 130 C / 180 C bar K VS m 3 /h Pressure Reducing Valve Hygienic Class HE3 DM 582 single-seat, angled design suitable for small and medium flow rates usable for liquids, gases and steam completely made of deep-drawn CrNiMo-steel (1.4435*) surface finish of the body Ra 0.8 μm hygienic class HE3 corrosion-resistant, very lightweight and compact elastomers as per FDA and USP Class VI reduced preheating time for CIP/SIP procedures, less energy needed adjusting screw as a function of display easy-tomaintain owing to the clamp system TRI-CLAMP connections or DIN/ISO clamp connections can be actuated pneumatically spring cap available with leakage line connection and adjusting screw seal DN PN G / NPT 3/ 4-2 T 130 C / 180 C bar K VS m 3 /h

4 No Pure Steam no Pharmaceutical Factory Most of the production sites in many industries require steam as an essential energy source. Steam is used whenever the supply of heat is mandatory for process engineering circuits. When it concerns pharmaceutical companies, the pure steam generator is among the most important devices, because it serves to produce ultra-pure, sterile and pyrogen-free steam from fully demineralised water. Such ultrapure steam is suitable for SIP sterilisation of equipment components, for instance tanks, mixing tanks, pipeline systems, bottling machines, filters, room humidification systems for clean rooms etc. The long list shows the broad spectrum of flow rates generally needed for pure steam generators. Main component of a pure steam generator is a tube bundle heat exchanger connected to an evaporator with a high-volume water feed. Evaporation is done in the natural circulation mode. The device is heated with saturated steam, which is not yet sterile, through the heat exchanger jacket. Pressure reducing valves reliably reduce the pressure of the steam which is conducted into the heating jacket as well as downstream of the heat exchanger towards the branching to the plant component or components. In doing so, various sizes of the Mankenberg pressure reducing valve DM 462 are employed. The valve is available in nominal diametres from DN 25 through to DN 80 or DN 100 for pharma applications with tempered (electropolished) surfaces and all types of connections such as aseptic flanges, TRI-CLAMPS or similar. In addition, the use of steel and low delta-ferrite contents, that are frequently demanded by the pharmaceutical industry, are ensured with the DM 462. Pressure Reducing Valve Hygienic Class HE5 DM 462 double-seat angled valve for high flow rate usable for liquids, gases and steam completely made of deep-drawn CrNiMo-steel (1.4435*), surface finish possible up to Ra 0.25 μm hygienic class HE5 virtually pocket-free, corrosion-resistant, lightweight and compact elastomers as per FDA and USP Class VI reduced preheating time for CIP/SIP procedures, less energy needed adjusting screw as a function of display easy-to-maintain owing to the clamp system TRI-CLAMP connections or DIN/ISO clamp connections PTFE protective foil for diaphragms can be actuated pneumatically spring cap available with leakage line connection and adjusting screw seal DN PN T 130 C / 180 C bar K VS 4-70 m 3 /h Pressure Reducing Valve Hygienic Class HE5 DM 462V double-seat straight-way or angled valve for medium flow rate usable for liquids, gases and steam completely made of deep-drawn CrNiMo-steel (1.4435*), surface finish possible up to Ra 0.25 μm hygienic class HE5 virtually pocket-free, corrosion-resistant, lightweight and compact elastomers as per FDA and USP Class VI reduced preheating time for CIP/SIP procedures, less energy needed adjusting screw as a function of display easy-to-maintain owing to the clamp system TRI-CLAMP connections or DIN/ISO clamp connections PTFE protective foil for diaphragms can be actuated pneumatically spring cap available with leakage line connection and adjusting screw seal DN 25 PN T 180 C bar K VS 4 m 3 /h

5 Regulation of the Water Supply for a Centrifuge Test Stand Plants and machines in the pharmaceutical and foodstuffs industry are highly sensitive systems and, in most cases, they are required to be CIP / SIP capable. Prior to their installation in the final customer s factory, they are comprehensively tested on the test stand of the manufacturer, who takes account of all the process parameters of the intended production facility. A mechanical engineering company specialised in plant design has installed an acceptance test stand for centrifuges. There, the plants and machines earmarked for testing can be set up at the test stations and connected to the supply lines. The supply points are equipped with process measurement devices, valves and also pressure reducers. The process parameters, that will prevail later during the operation of the valves, are adjusted and monitored there. The Mankenberg pressure reducing valve DM 462 controls the pressure of the demineralised control and process water during the test runs of the centrifuges. The double-seated, diaphragm-operated and spring-loaded proportional regulating valve DM 462 is predominantly used for hygiene applications. The diaphragm is physiologically unobjectionable owing to the PTFE protecting foil and can be exposed to steam in a temperature range up to 180 C. The pressure reducing valve is made of deep-drawn stainless steel with excellent resistance to corrosion and contains virtually no dead pockets. The angled design allows complete draining. Thus product contamination can be reliably excluded. Backpressure Regulator Hygienic Class HE5 UV 3.8M single-seat, angled design, straight-way valve for medium flow rates usable for liquids and gases completely made of deep-drawn CrNiMo-steel (316L) surface finish possible up to Ra < 0.25 μm hygienic class HE5 virtually pocket-free, corrosion-resistant, lightweight and compact adjusting screw as a function of display easy-to-maintain owing to the clamp system elastomers as per FDA and USP Class VI reduced preheating time for CIP/SIP procedures, less energy needed TRI-CLAMP connections or DIN/ISO clamp connections can be actuated pneumatically spring cap available with leakage line connection and adjusting screw seal DN PN 6-16 G 1/₂ - 2 T 130 C / 180 C p bar K VS m 3 /h Customised Solutions Your operating data determine the solution. Customer-specific solutions are individually designed valves for our customers special requirements. Mankenberg checks with every enquiry the customer-specific technical operating data and subsequently quotes the technical solution. If the operating data require solutions which cannot be realised with Mankenberg standard valves, our engineers will be happy to develop special solutions in accordance with our customer s enquiry. This may lead to either slightly modified valve type series or to a complex system. Discover our strength also in this case and send us your enquiry. example 2014 MANKENBERG GmbH

6 Gas Spring Cap Options for Generating the Set Pressure at Pressure Control Valves A mechanical spring or a pressurised gas spring and / or a pressurised gas cushion inside the so-called spring cap serve as setpoint adjuster for pressure control valves (for example pressure reducing valves, backpressure regulators or vacuum control valves). In principle, setpoint adjusters feature two different modes of operation: The purely mechanical adjustment The set pressure is generated by the manual pre-tension of the spiral spring that is supported by the spring cap. The spring of a pressure reducing valve keeps the valve open, consequently, it closes with the rising backpressure. The pressure spring of a backpressure regulator, however, keeps the valve closed; it opens with the rising upstream pressure. A regulating valve with simple spring cap is especially suitable for plants on which the set pressure must not be changed constantly. The pneumatic remote control In the gas spring cap, the set pressure is generated by the pressurised air acting on a diaphragm. An I/P converter regulates the control air pressure and, in return, receives its 4 20 ma signal directly from the process control system (PLS) or from a processor in the I/P converter. The regulating device then controls a pressure which is equivalent to the control air pressure. For this purpose, the version with only one diaphragm is required. To control pressures higher than the supplied control air pressure, a transformation ratio can be used. The transformation ratio results from the use of two diaphragms with differently sized so-called control surfaces. The advantages of the pneumatic control are the small control deviation, remote controllability and utilising the superposition of the mechanical spring force and the pressurised gas spring. Benefits are:» high accuracy» linear, continuous characteristics» directly acting, good dynamics, fast» well adapted for rapidly changing operating pressure conditions Mechanical Pressure Regulator activated by I/P Converter p I 4 20 ma (PLS) Control air Examples for Pressure Control Valves with Gas Spring Control:» DM 152» DM 462 / V» DM 505» DM 652» DM 662» UV 3.5» UV 5.1» UV 3.8 Simple gas spring cap with one diaphragm without transformation ratio Gas spring cap with two diaphragms using the transformation ratio

7 Pressure Reducer inlet pressure up to 250 bar 1 4 CrNiMo stainless steel (1.4435*), deep-drawn, corrosion-resistant, lightweight and compact long operational lifespan, easy installation, minimum space required, low delta ferrite content possible 2 connection: DIN-, ISO or TRI- CLAMP, aseptic flanges, weld-on ends... various flexible connections possible 3 Mankenberg clamp system easy-to-maintain 4 5 Internal Parts compliance with FDA USP Class VI 121 C approved for pharmaceutical and food processing plants external standard surface Ra 1.6 μm, optional up to 0.4 μm easy-to-clean 5 6 PTFE protecting foil physiologically unobjectionable, can be exposed to steam in a temperature range up to 180 C optional: compressed air connection for CIP / SIP processes 6 non-rising adjusting screw (optional protection against misplacement) unchanged overall height, function visible externally 7 7 internal surface standard up to Ra 0.25 μm, mechanically polished, electropolished compliance to the highest hygiene standards larger control surface optimal control accuracy Pressure Reducing Valve DM MANKENBERG GmbH

8 Media / Certificates Media Water» Demineralised Water, Deionised Water» Water For Injection (WFI)» Ultra-pure Water, Aqua Purificata (AP)» Flushing Fluids» Rinsing Solutions» CIP Solutions (Cleaning-In-Place) Gas» Sterile Air» Carbon Dioxide» Clean Gases» Nitrogen» Argon» Hydrogen Steam» Sterile Steam» Ultra-pure Steam» Pure Steam» SIP (Sterilisation-In-Place) Certificates Acceptance Hygiene and Material Certificates» FDA (Food and Drug Administration)» USP Class VI (United States Pharmacopeia)» Animal-derived free material certificate (TSE-free)» Surface Roughness Inspection» Helium Leakage Test» EN 10204/2.2» EN 10204/3.1 Please send us your enquiry and allow us to advise you. Sprechen Sie uns an und lassen Sie sich beraten. Mankenberg GmbH Spenglerstrasse 99 Mankenberg Luebeck I GmbH Germany Spenglerstraße Phone: +49 (0) Phone: info@mankenberg.de +49 (0) info@mankenberg.de Fax: Lübeck +49 (0) I Germany Fax: (0) Made in Germany