single-use solutions · single-use solutions - for pharmaceutical and biotech professionals...

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SINGLE-USE SOLUTIONSFOR PHARMACEUTICAL & BIOTECH PROFESSIONALS

Single Use Solutions – for Pharmaceutical and Biotech professionals2

About Colly Flowtech / UltraPure International

SINGLE-USE SOLUTIONS - FOR PHARMACEUTICAL AND BIOTECH PROFESSIONALS

UltraPure International is our own common brand within Indutrade Group!

UltraPure is a brand independent ISO9001:2015 certified assembling company. We create open architecture designs – assembling components from different manufacturers to meet our customer requirements.

WIDE EUROPEAN COVERAGESweden, Denmark, Norway, Iceland: Colly FlowtechIreland, UK: ESI UltraPureNetherlands, Belgium: Hitma UltraPureSwitzerland, Germany, Austria: Avintos

Part of Indutrade: Solid long-term commitment

SINGLE-USE ASSEMBLIES ■ We work with an open architecture concept ■ We offer a wide range of components from various brands ■ Production & quality records & documentation ■ Assembled in ISO 14644-1 certified clean room ■ ISO 9001:2015 quality management system ■ Double packed and gamma irradiated

CUSTOMIZATION & FLEXIBILITY ■ We assemble what you specify – Brand independent ■ Quick technical changes and redesign without extra costs

■ Exclusive stock-management possibility for continuity of your production process and to shorten lead times

■ Custom labelling and certification ■ Full flexibility also for small series ■ No MOQ requirements

SINGLE-USE COMPONENTS ■ World class suppliers

■ Market leaders and pioneers in their fields

■ Innovative and patented solutions

■ Tubing, connectors, couplings, bags, filters, sensors, pumps, valves, flowmeters, bottles, carboys

CUSTOM DESIGN ■ Short lead time from design to serial production ■ Close communication through all phases ■ Sketch design with the customer ■ 2D drawing for review ■ Sample delivery ■ Create final product ■ Quick technical changes and redesign without extra costs!

QUALITY & TRACEABILITY ■ ISO 9001:2015 certified ■ Batch Registration ■ Training Records ■ Supplier Qualification ■ Complaint/ Change Notification Process ■ CoC Registration ■ Quality Control/ Production Record ■ Cleanroom Maintenance & Calibration

SERVICE & COMMITMENT ■ Local presence - we are there when you need us ■ Single point of contact ■ Full responsibility for our recommendations ■ Fast efficient processes for non-conformities ■ Our aim is to offer the shortest lead time from first design

to serial production

OUR COMMITMENT AND CAPABILITIES

We work closely with our customers to find the best solution for their process.

We offer a flexible approach and keep constant communication with our customers to help them in any way we can.


Tubing - When it comes to tubing, no one can match the breadth of material formulations, application- specific functionality and decades of experience offered by Saint-Gobain Performance Plastics. From the iconic TYGON® brand to new innovations like Sani-Tech® Ultra their tubing products deliver purity, consistency and rock-solid documentation you can rely on.

Hoses - Saint-Gobain offer a variety of hose products to meet the most demanding conditions, all with ultra-smooth inner bores and excellent flexibility – even when reinforced for high-pressure applications.

Connectors - Saint-Gobain Performance Plastics’ product line includes several innovative connective technologies that provide the functionality, flexibility and high-purity performance.

TUBING

■ World class tubing

■ STHT®-C / STHT®-R silicone

■ C-FLEX®- weldable

■ TYGON® 2475 high-purity tubing

■ FDA, USP VI, ISO10993, European Pharmacopeia §3.1.9

CONNECTORS

■ PureFit© SIB smooth inner bore systems

HOSES

■ Rubber, PTFE, UPE, Silicon

■ Assembled to connections in SS 316 L

■ Full traceability

FILTRATION

■ Zenpure© Filtration Technology

Single Use Solutions – for Pharmaceutical and Biotech professionals 5

CPC is the leading provider of quick disconnect couplings, fittings and connectors for plastic tubing. They believe that fluid handling should be safe and easy, period.

For medical, biopharmaceutical, chemical handling, industrial, food processing and hundreds of other applications, CPC provides a full line of quick connects and disconnects. Designed for both quality and economy, their couplings and fittings are ideal for any plastic tubing application that needs quick and safe connection and disconnection. CPC products are easy to operate and maintain and we offer unique connection options to meet your specific needs.

ASEPTIC CONNECTORS ■ Genderless design

■ For sterile media transfer

■ Intuitive three-step connection process reduces risk of operator error

■ Repeatable and reliable design

■ Gamma stable

QUICK CONNECTORS ■ Meet biocompatibility requirements

■ USP Class VI materials

■ Sterilizable by autoclave, Et0, e-beam or gamma


Masterflex are proud to be the best option on the Biotech market when it comes to Peristaltic Tubing Pumps.

Quick installation, low maintenance and Easy tubing changeover is just a fraction of their strong sides. With their own branded tubing they handle almost any fluid from research to process. With a top-of-the-line service team and considerable stock holding, Masterflex makes the obvious choice for liquid handling.

PERISTALTIC PUMPS

■ Gentle, low-shear pumping

■ Original tubing design for optimal performance & lifetime

■ Comply with numerous standards and classifications, FDA, USP VI, EP etc.

■ Wide range of applications in numerous markets

■ Configurable systems

■ Many tubing options

■ Easy scale-up.

■ Flow ranges - 0.0006 mL/min to 42 L/min

■ Ethernet IP, Profibus and Bluetooth communication


LEVITRONIX is the worldwide leader in magnetically levitated Bearingless Motor technology, specializing in ultra-pure fluid handling devices for Life Science and Industrial applications.

Their patented technology permits the motor and magnetic bearing to be combined into a single unit with products that achieve maximum reliability, long life, and the ability to pump precious fluids in the harshest of environments.

LEVITRONIX offers the ideal solution for those applications that demand contaminant-free pumping, mixing or fluid control for extended periods without interruption for tubing changes in a highly reliable fashion.

CENTRIFUGAL PUMPS

■ Single-Use

■ Revolutionary Magnetically Levitated

■ Bearingless – no wear

■ Zero contamination

■ Pulsation free

■ Low shear design

FLOWMETERS

■ Single-Use inline

■ Clamp on

■ High precision


KEOFITT® A/S is the world leader in sterile sampling and is the only specialized company in sterilizable sampling valves in the world - nobody has as much experience as KEOFITT®.

KEOFITT® has an unparallelled portfolio of satisfied market leader customers and perform a constant product development in close co-operation with its customers.

KEOFITT® Sampling Bags have all been developed as single-use solutions to the cumbersome and difficult task of taking a representative sample and bringing it safe and clean from the sampling point to the laboratory.

STERILE SAMPLING VALVES AND SYSTEMS

■ KEOFITT® is the original in its field

■ All standard products are available from stock for

immediate delivery

■ Patented valve and membrane design

■ The largest and deepest product range

■ One universal and proven design regardless of application

SINGLE-USE SAMPLING SYSTEMS

■ STERILE Sampling Bags (single bag)

■ ASEPTIC Sampling Bags (single bag with valve system for steaming)

■ SPIKE Sampling Bags (single bag)

■ Medical grade plastics complying with all relevant FDA, USP and ISO

■ Delivered separately packed and gamma irradiated.

■ Validation documents covering SIP’ability, biocom-patibility, extractables, USP Class VI, endotoxins, mechanical and chemical properties etc


The Foxx Life Sciences team is made up of med-tech and life sciences industry experts with a major focus on innovation and engineering excellence.

Foxx Life Sciences provides engineering services, OEM and Foxx labeled proprietary products to leading research and distribution companies for a wide variety of applications. Their focus on next generation patented filtration, fluid management, and solvent waste products has accelerated their customers’ critical product-to-market timing objectives – a vital advantage in today’s competitive market.

Colly Flowtech are proud suppliers of the wide range of innovative and patented Filters, the big variety of Carboys, Flasks and Bottles and much more produced by Foxx Life Science.

BOTTLES, FLASKS, CARBOYS ■ EZBio® Single-Use media bottles, from 60 mL to 2000 mL

■ VersaCap® providing unparalleled versatility

■ Vacuum bottles

■ Plastic flasks

■ Solvent waste systems

■ Carboys - widest range of sizes, 2 L to 75 L

■ Polycarbonate, Polystyrene, PETG,

■ Polypropylene, HDPE, PFA

FILTRATION ■ Bottle Top Filtration System

■ Syringe filters – hydrophobic venting and solvent filtration application

MIXING ■ Teras Turbine – patented mixing technology


Colly Flowtech offer a complete range of Single-Use Solutions for the Bio-Pharmaceutical industry!

We represent some of the world leaders in this segment and can offer complete assemblies produced in our own clean room facility. Our aim is to offer the shortest lead time from first design to serial production! We can handle any volumes from small single unit series and upwards.

SINGLE-USE ASSEMBLIES

■ Short lead time from inquiry to delivery

■ Brand independent

■ We assemble what you specify

■ Quick technical changes and redesign without extra costs

■ Production & quality records & documentation

■ Assembled in ISO 14644-1 certified clean room

■ Double packed and gamma irradiated


Many of our customers used to do it themselves, from sourcing the components from various suppliers, organizing the logistics, managing the certificates, do the assembling, autoclave and drying, before use. We can do all this for you so you can use your capacity elsewhere, we supply the complete assembly, double packed including COCs and gamma irradiated – Ready to use!

COMMITMENT AND CAPABILITIES

■ Small or big series does not matter.

■ We can supply all known brands in our assemblies

■ We can help making the design or improving the existing design

■ First drawing within one week

■ First sample within five weeks

■ Serial production within ten weeks

■ We manage the documentation package

■ We guarantee the conformity and quality

■ You will gain time, speed, quality, functionality, safety, better working environment


With 50 years experience in delivering high purity components for high technology industries, Entegris provides a new class of fluoropolymer Single-Use bags to meet requirement in terms of contamination and mechanical strength especially at low temperature.

With a new film technology, the SU bag is designed to decrease mitigation risk in drug solutions at the fill & finish, storage and transport, stem cell and cell therapy applications either at R&D or production stage.

2D SINGLE-USE BAGS - ARAMUS TM

■ Gamma stable fluoropolymer

■ No additives - Very low extractables

■ Single layer - No delaminating

■ Inert - No chemical limitations

■ Wide temperature range - Stable in cryogenic applications down to -85°C

■ Purity – low E&L, bioburden & particulates


Acro is a leading innovator of pinch valves and integrated fluid control assemblies for the medical, bioprocessing and industrial markets.

With 45 years of experience, their products have given engineers who are designing fluidic based systems elegant, non-wetted contact solutions to precisely control, monitor and integrate into a diverse set of equipment applications.

PNEUMATIC AND SOLENOID PINCH VALVES

■ Designed for Single-Use tubing

■ Easy snap in slot for tubing – for quick loading and unloading

■ Panel or base mount

■ Designed for Single-Use tubing up to 1,5” OD

■ Eliminate potential contamination of media

■ Long performance and reliability

■ Easy valve exchange

■ Black anodized aluminum or stainless steel 316L material options

■ Proportional control available


Ultrapharma has become Europe’s largest Sanitary Gasket supplier. Ultrapharma have developed several innovative products to reduce down time in critical processes.

By carrying a large inventory of both US & EU standards, specialty products and consumable items, Ultrapharma is the single source for high performance seals in the Life Science industry.

SINGLE-USE COMPONENTS

■ Pharma-Clamp® - Non-metallic clamps

■ Clamp gaskets, FDA, USP VI, Animal free origin

■ Snap-On™ Gaskets, compression controlled, Steam-Flon® -212°C to +288°C

■ Pressure gauge

■ Manual Pinch valves

■ Adjustable valves

MULTI-USE COMPONENTS

■ Metallic clamps

■ Torque clamps

■ Anti vibration Wing nut


ARTeSYN® is a visionary brand in the area of single-use flow solutions. ARTeSyn provide nextgeneration, single-use component and system variations for the global biopharma industry.

Years of experience allow the team at ARTeSYN® to develop and manufacture previously unimagined single-use products and filling needs that a lot of users did not realize they had. Countless times, the team at ARTeSYN® has been asked, “why didn’t I think of that?” ARTeSYN® Biosolutions is now recognized globally as an innovative, industry-leading organization and brand.

MANUAL PINCH VALVES

■ Non-product contact

■ Non-rotating hemispherical plunger very fine fluid control

MULTI-VALVE MODULES

■ Patented ARTeSYN® multi-valve

■ Ideal solution for managing multiple flow paths

■ Closures minimizing all possible hold-up volumes

DIAPHRAGM REPLACEMENT VALVES

■ Molded ARTeSIL® silicone liners

■ Exceptional flow control, ± 2%

■ No dead-legs and minimized hold-up volumes

■ Available in customized variations


STAINLESS STEEL PIPES AND FITTINGS ■ Fully equiped mechanical workshop

■ Certified welders

■ Inhouse electropolishing

■ Pipes and fittings in SMS, OD, DIN etc

■ Customized design/construction

■ Gaskets and packings

TANK & PIPE CLEANING ■ Jet and spray nozzles

■ Pig systems

HOSES ■ Any material: Silicone. flouropolymer, rubber, stainless steel

■ FDA, USP VI, AFO, ATEX

■ Documentation, certificates, traceability

■ Customized hose design

HOSE ASSEMBLIES ■ Inhouse assembly

■ Pressure tested

■ Any fittings, SMS, Tri-Clamp. DIN, Kamlock

MULTI-USE SOLUTIONSFOR PHARMACEUTICAL & BIOTECH PROFESSIONALS


We are experts in multi-use pump solutions for Pharmaceutical and Biotech applications.

We represent some of the strongest pump brands on the market. We have more than 35 years of experience within the pump industry and can support you with all various applications. All pumps come with a complete documentation package including 3.1 cert, USP VI and FDA compliance etc.

MULTI-USE PUMP SOLUTIONS

■ ■ Buffer transfer

■ ■ Emulsions

■ ■ UF/Diafiltration

■ ■ Shear sensitive product transfer

■ ■ Aceptic ingredients

■ ■ WFI

■ ■ CIP systems

■ ■ Detergents

ANTECKNINGAR:

PRODUCT INTEREST COMMENTS

Saint-Gobain

CPC Colder

Masterflex

Levitronix

Keofitt

Foxx Life Science

Colly Flowtech Ultrapure

Entegris

Acro Bimba

Ultrapharma

Artesyn

PARTICIPANT COMPANY EMAIL

COMMENTS

Colly Flowtech AB Box 81, Raseborgsgatan 9, 164 94 Kista, Sweden. Tel. +36 (0)8-703 01 30. Fax: +36 (0)8-752 99 92

UltraPure International B.V.J.N. Wagenaarweg 1, 1422 AK Uithoorn, The Netherlands. Tel. +31 (0)297 514 700

single-use solutions · single-use solutions - for pharmaceutical and biotech professionals...

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