SteridoSe SaleS

Head office: Himmelsbodavägen 7P.o.Box 120 · Se-147 22 tUMBa · SWedeNPhone: +46-8 449 99 00 · Fax: +46-8 449 99 90info@steridose.com · www.steridose.com

regional office: 5020 World dairy drive · Madison, Wi 53718 · USaPhone: +1-608 229 5225 · Fax: +1-608 227 9599info@steridose.com · www.steridose.com

...pure mixing

STERIFLANGE®

FunctionSteriflange 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.

DesignThe 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.

Technical dataProduct contact surfaces are finished to Ra<0.5µm or better.Traceability certificates according to EN 10204 (3.1B) 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.

Features• 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

Steriflange®

Flush mounted instrument.

Steriflange®

Flush mounted sampling valve.Sterivalve®

Steriflange®

Flush mounted sampling system.Sterisample®

Traditional Triclamp connectors are hard to clean by spray ball

STERIDOSE PHARMACEUTICAL PRODUCTS

providing the perfect mix

.

STERIDOSE® STERIMIXER® STERIVALVE®

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.

Mixing principle

A unique magnetically coupled mixerThe 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.

Self purging design – SMAThe 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 – SMOThe SMO impeller features an open design that exposes the interior of the mixer and can be readily cleaned using typical in-vessel 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.

InterchangeabilityThe SMA and SMO impellers both use the same bearing and weld-plate assemblies and are fully interchangeable.

A wide choice of modelsSterimixer 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.

Total quality conceptSterimixer 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.

ReferencesWorldwide 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.

Product Overview

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®, Steriflange® 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

About the Company

General Specifications

Valve housing 316l, other material on request

Surface Finish ra 0,4µm, electropolished

Valve size 0.5” 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

Shut-off 90°

Steridose providing the perfect mixThe 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.

Hygienic design for biopharmaceutical applicationsThe 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.

CIP and SIP performanceThe 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 self-draining 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.

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.

STERIDOSE PHARMACEUTICAL PRODUCTS

divert

take-off

Flow-through

Bottom outlet -single

Bottom outletwith satellite

Bottom outletwith side port

Bottom outlet -double

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.

Sterivalve®

Flush mounted, bottom outlet radial diaphragm valve.

Sterimixer®

Bottom-entry magnetically coupled mixer.

Steriflange®

Flush mounting of gauges, probes or sampling systems

Sterivalve®

Flush mounted sampling valve.

.

STERIDOSE® STERIMIXER® STERIVALVE®

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.

Mixing principle

A unique magnetically coupled mixerThe 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.

Self purging design – SMAThe 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 – SMOThe SMO impeller features an open design that exposes the interior of the mixer and can be readily cleaned using typical in-vessel 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.

InterchangeabilityThe SMA and SMO impellers both use the same bearing and weld-plate assemblies and are fully interchangeable.

A wide choice of modelsSterimixer 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.

Total quality conceptSterimixer 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.

ReferencesWorldwide 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.

Product Overview

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®, Steriflange® 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

About the Company

General Specifications

Valve housing 316l, other material on request

Surface Finish ra 0,4µm, electropolished

Valve size 0.5” 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

Shut-off 90°

Steridose providing the perfect mixThe 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.

Hygienic design for biopharmaceutical applicationsThe 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.

CIP and SIP performanceThe 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 self-draining 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.

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.

STERIDOSE PHARMACEUTICAL PRODUCTS

divert

take-off

Flow-through

Bottom outlet -single

Bottom outletwith satellite

Bottom outletwith side port

Bottom outlet -double

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.

Sterivalve®

Flush mounted, bottom outlet radial diaphragm valve.

Sterimixer®

Bottom-entry magnetically coupled mixer.

Steriflange®

Flush mounting of gauges, probes or sampling systems

Sterivalve®

Flush mounted sampling valve.

.

STERIDOSE® STERIMIXER® STERIVALVE®

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.

Mixing principle

A unique magnetically coupled mixerThe 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.

Self purging design – SMAThe 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 – SMOThe SMO impeller features an open design that exposes the interior of the mixer and can be readily cleaned using typical in-vessel 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.

InterchangeabilityThe SMA and SMO impellers both use the same bearing and weld-plate assemblies and are fully interchangeable.

A wide choice of modelsSterimixer 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.

Total quality conceptSterimixer 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.

ReferencesWorldwide 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.

Product Overview

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®, Steriflange® 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

About the Company

General Specifications

Valve housing 316l, other material on request

Surface Finish ra 0,4µm, electropolished

Valve size 0.5” 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

Shut-off 90°

Steridose providing the perfect mixThe 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.

Hygienic design for biopharmaceutical applicationsThe 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.

CIP and SIP performanceThe 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 self-draining 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.

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.

STERIDOSE PHARMACEUTICAL PRODUCTS

divert

take-off

Flow-through

Bottom outlet -single

Bottom outletwith satellite

Bottom outletwith side port

Bottom outlet -double

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.

Sterivalve®

Flush mounted, bottom outlet radial diaphragm valve.

Sterimixer®

Bottom-entry magnetically coupled mixer.

Steriflange®

Flush mounting of gauges, probes or sampling systems

Sterivalve®

Flush mounted sampling valve.

.

SteridoSe SaleS

Head office: Himmelsbodavägen 7P.o.Box 120 · Se-147 22 tUMBa · SWedeNPhone: +46-8 449 99 00 · Fax: +46-8 449 99 90info@steridose.com · www.steridose.com

regional office: 5020 World dairy drive · Madison, Wi 53718 · USaPhone: +1-608 229 5225 · Fax: +1-608 227 9599info@steridose.com · www.steridose.com

...pure mixing

STERIFLANGE®

FunctionSteriflange 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.

DesignThe 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.

Technical dataProduct contact surfaces are finished to Ra<0.5µm or better.Traceability certificates according to EN 10204 (3.1B) 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.

Features• 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

Steriflange®

Flush mounted instrument.

Steriflange®

Flush mounted sampling valve.Sterivalve®

Steriflange®

Flush mounted sampling system.Sterisample®

Traditional Triclamp connectors are hard to clean by spray ball

STERIDOSE PHARMACEUTICAL PRODUCTS

providing the perfect mix

.

SteridoSe SaleS

Head office: Himmelsbodavägen 7P.o.Box 120 · Se-147 22 tUMBa · SWedeNPhone: +46-8 449 99 00 · Fax: +46-8 449 99 90info@steridose.com · www.steridose.com

regional office: 5020 World dairy drive · Madison, Wi 53718 · USaPhone: +1-608 229 5225 · Fax: +1-608 227 9599info@steridose.com · www.steridose.com

...pure mixing

STERIFLANGE®

FunctionSteriflange 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.

DesignThe 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.

Technical dataProduct contact surfaces are finished to Ra<0.5µm or better.Traceability certificates according to EN 10204 (3.1B) 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.

Features• 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

Steriflange®

Flush mounted instrument.

Steriflange®

Flush mounted sampling valve.Sterivalve®

Steriflange®

Flush mounted sampling system.Sterisample®

Traditional Triclamp connectors are hard to clean by spray ball

STERIDOSE PHARMACEUTICAL PRODUCTS

providing the perfect mix

.