providing the perfect mix

Transcription

1 providing the perfect mix

2 STERIDOSE STERIDOSE PHARMACEUTICAL PRODUCTS About the Company Steridose is a Swedish company highly specialized in the design, development and manufacturing of Mag-Drive mixers, radial diaphragm valves, aseptic connectors and sampling systems Sterimixer, Sterivalve, and Sterisample are all registered trademarks of Steridose AB Steridose AB is a part of the Roplan Group, with regional offices in key locations around the world Our head office is located in Tumba, Sweden with a regional office in Madison WI, USA and global presence through our network of distributors and representatives Our products are manufactured according to current bio-pharmaceutical equipment standards, enabling us to maintain superior quality and product traceability Our 300 m2 fully equipped laboratory provides services for customer mixing studies, as well as enabling verification of product design Product Overview Sterivalve sampling valve Sterivalve, bottom outlet radial diaphragm valve Flush mounting of gauges, probes or sampling systems Sterimixer Bottom-entry magnetically coupled mixer

3 STERIMIXER A unique magnetically coupled mixer A wide choice of models The Sterimixer may be the most widely used magnetically coupled mixer for biopharmaceutical applications world wide It consists of the following major components: impeller, bearing, weld-plate, drive unit and control box All wetted parts of the impeller and the weld-plate are made of AISI 316L stainless steel Two impeller designs are available: SMA and SMO Sterimixer models are available for vessel volumes ranging from 5 liters to beyond 30,000 liters, with or without control cabinets and with various types of drive units: AC, AC stainless steel, DC, Air, together with explosion proof and ATEX options The Sterimixer is manufactured in accordance with relevant industry standards and requirements such as: ASME BPE, applicable pressure vessel codes, material traceability requirements and the EU Machine Directive 2006/42/EC, Annex IIB Self purging design SMA The SMA impeller has horizontal flow-channels that ensure continuous purging of liquid through the bearing and from beneath the impeller Therefore the SMA impeller is especially suited for applications with soils that are not easily removed from wetted surfaces during cleaning Its patent design optimizes CIP performance while running the impeller submerged in the cleaning solution The SMA is CIP and SIP capable Open design SMO The SMO impeller features an open design that exposes the interior of the mixer and can be readily cleaned using typical invessel equipment - for instance a fixed spray device aimed at the impeller with purge directly to the vessel drain The impeller does not need to be submerged during the CIP cycle The SMO is CIP and SIP capable Interchangeability Total quality concept Sterimixer manufacturing is quality assured and certified to be in accordance with ISO 9001 by Lloyds Register Quality Assurance Sterimixer is also provided with all relevant documentation required for validation purposes References Worldwide references for the Sterimixer include the manufacture of blood protein fractions, delicate cell suspensions, insulin, LVPs, vaccines, buffer solutions and oral liquids Using our experience combined with a history of manu factur ing excellence and full technical support, Steridose can guide you to obtain the most user-friendly and cost-effective solution for your application Our Research & Development Center and test equipment are available for confidential customer product testing The SMA and SMO impellers both use the same bearing and weld-plate assemblies and are fully interchangeable Mixing principle 1 - Soluble powder or liquid is added into the vortex It is then rapidly transported downwards to the impeller 2 - After reaching the impeller, the fluid flows in a radial direction towards the vessel wall 3 - After reaching the vessel wall, the fluid travels upwards and then circulates down to the impeller again The overall bulk movement and the mixing action around the agitator ensure that a homogeneous concentration distribution is achieved

4 STERIVALVE Steridose providing the perfect mix CIP and SIP performance The Sterivalve range provides high performance flow control for pharmaceutical and biopharmaceutical liquid processes Using a hydrodynamically optimized design, the Sterivalve combines the best features of a piston valve with the inherent cleanability of a flat diaphragm valve This combination of features ensures that the Sterivalve offers the unique combination of low flow resistance together with a proven hygienic design The Sterivalve is made from durable materials with a robust construction, which combined assure a long service life under demanding conditions The Sterivalve has been used and validated in a wide range of clean and sterile processes worldwide The design of the housing, which features a low residual internal volume, ensures optimal velocity of cleaning agents during the CIP process The selfdraining and open internal structure of the valve housing also ensure safe and reproducible CIP and SIP performance; thus avoiding the risk of bacterial and endotoxin contamination, or undesirable temperature gradients It is also possible to clean and sterilize both the inlet and outlet pathways of the Sterivalve in the closed position if required These features enable the process engineer to design an efficient piping system with optimized and risk-free product flow Hygienic design for biopharmaceutical applications The Sterivalve has a unique patented design using a configuration in which the valve diaphragm is clamped between the valve body and the actuator All moving parts in the actuator are completely isolated from contact with the process fluid and tools are not required for disassembly or service for most valve sizes Both the valve housing and the piping connections are self draining without dead-legs By specifying the Sterivalve, the total number of valves in a system may be reduced by up to 30% in comparison with traditional flat diaphragm valves This will result in a reduction in hold up volume of the complete piping system General Specifications Valve housing 316L, other material on request Surface Finish Ra 0,4µm, electropolished Valve size 05 to 3 Outlet connections But weld (BW), TC- ends Standards ASTM, other standards on request Option Steam port, CIP/SIP satellite valve Actuator Manual or pneumatic, Stainless steel or plastic, Inductive or microswitch actuator indicators Option Atex indicators Diaphragms Silicone, EPDM and PTFE, USP <88> Class VI Total quality concept The manufacturing of Sterivalve is quality assured and certified in accordance with ISO 9001 and benefits from our extensive experience within the pharmaceutical industry Shut-off 90 Bottom outlet single Flow-through Bottom outlet double Take-off Bottom outlet with side port Divert Bottom outlet with satellite

5 STERIFLANGE STERIDOSE PHARMACEUTICAL PRODUCTS Function Technical data Steriflange is an aseptic mounting flange for all types of equipment mounted to vessels such as temperature transmitters, level transmitters and sample-valves with clamp connections It gives superior CIP/SIP (Cleaning In Place/Sterilisation In Place) performance and allows equipment to be flush mounted on top, bottom and side of vessel Product contact surfaces are finished to Ra<05µm or better Traceability certificates according to EN (31B) are always supplied with Steriflange as standard Gasket can be supplied in accordance with FDA regulations, and are also available in compliance with USP <88> Class VI Design Eliminates dead legs Easy to clean/sterilise vessel equipment No ferrules or threads No air pockets during sterilisation Flexible flanging for different equipment Secured CIP/SIP procedure The mounting plate is designed to be welded to the vessel The locking ring consists of two parts, in order to obtain double safety and facilitate mounting of the equipment Steriflange is supplied as a complete unit and is welded to the vessel It is manufactured in AISI 316L stainless steel Other materials are available upon request Steriflange is available in different sizes and connection standards instrument sampling valve Sterivalve Features Traditional Triclamp connectors are hard to clean by spray ball sampling system Sterisample

6 pure mixing Steridose Sales Head Office: Himmelsbodavägen 7 POBox 120 SE TUMBA SWEDEN Phone: Fax: info@steridosecom wwwsteridosecom Regional Office: 5020 World Dairy Drive Madison, WI USA Phone: Fax: info@steridosecom wwwsteridosecom