SINGLE-USE SOLUTIONS

Transcription

1 SINGLE-USE SOLUTIONS FOR PHARMACEUTICAL & BIOTECH PROFESSIONALS

2 SINGLE-USE SOLUTIONS FOR PHARMACEUTICAL AND BIOTECH PROFESSIONALS Alflow Scandinavia offers a wide range of single-use products and solutions for the pharmaceutical and biotech industries. With 20 years experience and our one-stop-shop concept, we provide state-of-the-art, high-quality single-use products and solutions to help our customers secure and optimize their valuable single-use processes. ALFLOW AS YOUR SINGLE-USE PARTNER 20 years experience in pharmaceutical and biotech industry One-stop shop - save time and ressources Respected and well-known suppliers Thorough quality and documentation control Local presence - onsite support and service with short notice Extensive warehouse capacity for day-to-day delivery SINGLE-USE ASSEMBLIES We offer a wide range of components from various brands Assembled and packaged in Class 7 (Class 10,000) ISO-certified clean rooms Available with validated sterility assurance of 10-6 per ISO method VDmax 25 Double packed, gamma irradiated and certified sterile Documented lot traceable with identification on bags Experienced engineers available for technical assistance SINGLE-USE COMPONENTS World-class suppliers Market leaders and pioneers in their fields Innovative and patented solutions Custom assemblies, tubing, fittings & connectors, couplings, gaskets, bags, bottles, carboys, pass-through technology, sealers & welders, gauges, valves 2

3 A COMPLETE SOLUTION CUSTOM DESIGN & FLEXIBILITY We assemble what you specify Short lead time from design to serial production Close communication through all phases Sketch design with the customer 2D drawing for review Sample delivery with short lead time Experienced single-use engineers available QUALITY & TRACEABILITY ISO 9001:2015 certified Batch registration Supplier qualification Change-notification process Certificate of compliance Certificate of analysis Quality control Extractrables and leachables studies Thorough validation packages All documentation will be filed and stored ISO 9001:2015 CERTIFIED SERVICE & COMMITMENT Local presence We are there when you need us with short notice Single point of contact Dedicated employees with single-use experience Our goal is to provide state-of-the-art, high-quality products and solutions to help our customers secure and optimize their valuable single-use processes 3

4 AdvantaPure, the high-purity products division of NewAge Industries, is designed to anticipate and satisfy the evolving needs of the pharmaceutical and biopharmaceutical manufacturing industries. AdvantaPure is ISO 9001:2015 certified, and many of their products meet and exceed USP Class VI, FDA, ISO, NSF, 3-A, and European Pharmacopoeia standards. All products are manufactured, stored, and shipped using the cleanest methods possible to ensure unsurpassed product purity for the customer. TUBING Platinum-cured silicone tubing High-pressure, platinum-cured silicone tubing Platinum-cured silicone pump-grade tubing Reinforced, platinum-cured silicone tubing AdvantaFlex weldable and sealable TPE tubing Manufactured and packaged in Class 7 ISO-certified clean rooms CONTAINER CLOSURES Platinum-cured silicone or AdvantaFlex TPE For single or repeated use Sterilizable through autoclave processes or gamma radiation Assembled and packaged in Class 7 ISO-certified clean rooms Documented quality control MANIFOLDS Custom-manufactured and assembled from a variety of components We assemble what you specify Experienced single-use engineers available for design Assembled and packaged in Class 7 ISO-certified clean rooms MOLDED PRODUCTS Custom-manufactured manifolds assembled from a variety of components Molded fill/finish manifolds for reduced risk of leakage and potential product loss Reduces cross-contamination risks For use with flexible container systems, laboratory apparatus and bottles, sampling and storage receptables of glass, plastic and metal Assembled and packaged in Class 7 ISO-certified clean rooms 4

5 AdvantaPass permits the aseptic transfer of fluids between the walls of pharmaceutical and biopharm manufacturing suites. It s the first system of its kind to offer complete isolation between different classes of clean rooms when transferring multiple lines of fluid through a single wall portal. AdvantaPass is a patented system that provides a practical, safe, secure and easy way to move large volumes of liquids from one room to another without the risk of bin damage or product loss. Its incorporation of single-use disposable components eliminates cleaning validation requirements that involve thye expense and waste of time, labor and natural resources. PASS-THROUGH TECHNOLOGY Custom manufactured with standardized parts Proven, reliable materials Single-use process components made of platinum-cured silicone or TPE Portal assemblies made from solid 316L stainless steel Single-Use components eliminate the need to clean and validate traditional hard piping transfer lines Easy and quick assembly/disassembly Highly adaptable and works with various wall and floor thicknesses Design flexibility can be used in new construction or retrofitted into existing facilities; no welding involved Standard sizes op to 6 diameter - larger sizes on request Provides a reliable method for transferring fluids without physically moving bins and totes, thereby eliminating the risk of bin damage, breakage and lost product during bin transfer Does not involve multiple moving parts or frequent maintenance like other in-wall pass-through systems 5

6 Vante Biopharm is a leading manufacturer of sealing and welding technology for TPE, PVC and EVA hoses for sterile single-use processes in biopharmaceutical manufacturing. For more than 40 years, they have specialized in developing and manufacturing hose sealers to create sterile seals for hoses for the collection, storage and treatment of pharmaceutical fluids. SEALERS Sealers for TPE, PVC, EVA and Urethane Durable, compact design Seals up to 1 OD tubing Hand-held sealing head with standard 8 ft cable Remote operation - easy and convenient for operators to use Fast and reliable No compressed air required Standard 16 adjustable recipe slots Spring support on lower jaw provides compression which ensures a tight and secure seal WELDERS Sterile welder for TPE hoses Automated features ensure the correct temperature and location of the hose Tubing can be wet, dry or fluid-filled Compact footprint which saves cleanroom space User-friendly and easy to use - minimal user interface Self-controlled heating operation with temperature monitoring Fast and reliable 6

7 With more than 50 years experience, Nordson MEDICAL is a global expert in the design, development, and manufacturing of complex medical devices and component technologies. They serve biotechnology manufacturers with world-class single-use fluid-transfer components. CLAMPS Easy-open clamps and tube clamps BioClamp and BioValve pinch valve ASME BPE 2014 & DIN compliant USP Class VI & ISO certified glass-filled nylon Easy to use, one-handed closure Cryogenic freezing to -80 C Autoclavable and SIP/CIP compatible Gamma radiation up to 50 kgy QUICK CONNECTORS Materials meet USP Class VI criteria large ergonomic button and thumb pad with secure latch and optimal intergrated locking mechanism supports cruogenic applications to -60 C several connector configurations available in commonly used polypropylene and polycarbonate materials SANITARY FITTINGS AND GASKETS Autoclavable Can be delivered gamma-irradiated and double-bagged Barbed fittings, multiport fittings, Y-pieces, T-pieces, instrument tees, end caps, bag ports, etc. Animal-Free Polypropylene, Polyethylene and natural PVDF USP Class VI PTFE/EPDM and platinum-cured silicone gaskets Compliant with FDA, EU 10/2011 and EC 1935/2004 7

8 With 50 years experience in providing high-purity components for high-tech industries, Entegris offers the next generation of single-use bags made from fluorpolymer (teflon) to meet requirements in terms of contamination, purity and strength - especially at low temperature. The single-use bag, Aramus 2D, provides increased safety and performance with a single-layer, gamma-stable fluorpolymer (teflon) film. The unique one-layer technology means no delamination, resulting in very low extractables and leachables and securing the highest level of purity in your process. The single-use bags have a wide temperature range and are ideal for safe transportation, storage and dispensing of high-purity materials - especially at low temperatures (down to -85 C) 2D SINGLE-USE BAGS - ARAMUS TM ONE-layer technology - no binders, agents, additives or adhesives World s first and only high-grade, gamma-stable fluorpolymer (teflon) single-use bag Wide temperature range Suitable for frozen applications down to -85 C without going brittle or fragile High-purity materials Outstanding chemical compatibility Very low extractables and leachables Typical applications: drug solutions, fill & finish, storage transport, stem-cell therapy, frozen-product storage and shipment, storage of critical buffers and media, downstream bioprocessing, process sampling and archiving, etc. 8

9 ARTeSYN is an emerging visionary brand in the designing and manufacturing of single-use valves and components. They develop, manufacture and supply a series of these single-use products targeting the voids in the current single-use market division. The patented ARTeSYN designs are a truly revolutionary fluid-management technology for all disposable process system applications. Their products are versatile and customizable to any and all needs required, as their valves are available as single or multi-valve arrays. The ARTeSYN single-use fluid-control concept provides outstanding performance with unequalled flow controllability. DIAPHRAGM REPLACEMENT VALVES Molded ARTeSIL disposable silicone liners Exceptional flow control, ±2% No deadlegs and minimized hold-up volumes Available in customized variations Quick and easy change of the disposable liner Compact design which is easy to use Manually or pneumatically operated MANUAL PINCH VALVES No product contact Non-rotating hemispherical plunger very fine fluid control Manually or pneumatically operated MULTI-VALVE MODULES Patented ARTeSYN multi-valve Ideal solution for managing multiple flow paths Closures minimizing all possdible hold-up volumes 9

10 10 Quattroflow develops and manufactures single-use diaphragm pumps for critical applications in the biopharmaceutical industry. This technology is CIP/SIP capable and offers disposable solutions that increase flexibility, reduce down-time, eliminate costs of cleaning validation, and risks of cross-contamination. Quattroflow single-use pumps are equipped with a product-wetted plastic pump chamber that can be replaced as a complete unit. The simple disposal of the pump chamber saves time and money, because it drops the efforts for cleaning, sterilization and complex cleaning validation. The use of Quattroflow Single-Use pumps creates a quicker production process, as well as one that delivers the required levels of product purity and sterility with no harm to the product and no chance for costly cross-batch or cross-product contamination. SINGLE-USE PUMPS Disposable wetted pump chamber constructed of solid polypropylene (PP) or injection-molded polyethylene (PE) The simple disposability of the pump chamber saves time and money by eliminating cleaning validation, sterilization and product cross-contamination Minimal maintenance - minimal downtime Quattroflow pumps help minimize particle contamination of your product, reduce heat and are suitable for securing the handling of expensive and/or sensitive liquids Quattroflow pumps virtually eliminate particle generation which is commonly seen with the use of other pump types such as peristaltic pumps SINGLE-USE FLOW METERS High accuracy Inline or Clamp-on version Inline version constructed of polypropylene (PP) wet material, TriClamp fittings Reusable clamp-on version for Silicone/AdvantaFlex tubing

11 TERMS & CONDITIONS Alflow reserves the right to continually change these terms and conditions without notice to you, business partners, customers and third parties in general. Equally, Alflow reserves the right to disclaim any misprints or typing error that can occur. Therefore, Alflow advise you to review them regularly. The updated version of these terms and conditions can always be reviewed by accessing the Alflow s website and enter By doing business with Alflow, you agree to be bound by these terms and conditions. Furthermore, the General Standard Conditions of NL 92 for deliveries of machinery and other mechanical, electrical and electronic equipment between Denmark, Finland, Norway and Sweden as well as within these countries, applies thus you agree to be bound by these conditions set forth in the NL 92. Description of Products and Services Alflow is an exclusive distributor of flow components in artificial materials as well as stainless steel for among others the pharmaceutical, chemical and food industries. Alflow provides products and accessories and spare parts thereto that originate from many recognized manufacturing brands of high quality products such as pumps, valves, pipes pharma & fittings, tubing, agitators and mixers, as well as related products therefor in plastics as well as stainless steel. Alflow provides the technical advice, coaching, services and sales connected to Alflow distributed products. All Alflow provided products and accessories and spare parts thereto are subject to the standard limited product warranty set forth in NL 92 and in these terms under Disclaimer and Liability. Disclaimer and Liability These terms, together with the General NL 92 Conditions, describe the full extent of Alflow s obligations in connection with the distribution of the products. Specifically, Alflow carries no responsibility for ensuring that products are suitable for your special purposes. Neither Alflow nor any of its affiliates are liable for any loss or damage that the delivered equipment is causing the products manufactured by the buyer or products in which these products are used. Equally, Alflow is not liable for damage to real or personal property caused by the delivered products. Moreover, Alflow cannot be held responsible for indirect loses such as, but not limited to, loss of profit and other consequential economic losses. Alflow only distributes accessories and spare parts for the third parties appearing on the list of brands on the Alflow website: Alflow is not commercially linked, sponsored nor does it represent any of the brands included or referred to on the website or Alflow product catalogues. Your order and delivery of products does not create any form of relationship between Alflow and these brands. Alflow may provide links to third party websites and applications. Your use of such third party websites and/or applications is at your own risk. All referrals made to names, brands, serial numbers, images, materials and etc. is for descriptive and informational purposes only. Alflow does not assume any liability in connection to the use of third party websites or referred information. Intellectual Property Rights All intellectual property rights including copyright to photos used on this website are owned by or duly licensed to Alflow for distribution and commercial purposes. Copying, processing, distribution and any kind of exploitation outside the copyright limits require the prior written consent of Alflow or the respective creator or holder of the copyright. Downloads and copies of these pages are permitted only for private, non-commercial purposes. To the extent the content is not created by Alflow, there are obtained corresponding license to third party copyrights. Alflow is a trademark registered in favor of Alflow Scandinavia A/S in the European Union and other jurisdictions. This trademark should not be associated with products or services that are not from Alflow, and may not be used in any manner that is likely to be confused by Alflow customers or liable to impair the reputation of Alflow or bring it into disrepute. Governing Law and Jurisdiction Any dispute arising from the purchase, distribution and/or delivery of the Alflow products or the interpretation of these terms and conditions is governed by the laws of Denmark, excluding its conflicts of law rules. The exclusive venue for any and all disputes arising from or in connection Alflow shall be The Danish Maritime and Commercial Court. Provisions independency If any provision of these terms and conditions is deemed to be illegal, invalid or unenforceable, that provision shall be deemed separated from the conditions of distribution and shall have no effect on the remaining provisions valid or enforceable. The illegal, invalid or unenforceable provision shall then be replaced by a valid provision, which as far as possible reflects the economic purpose and intent of the original provision. These terms apply to all sales and distribution from Alflow Scandinavia A/S to any buyer, business partner and/or third party in general, irrespectively of the jurisdiction of said party. 11

12 Jacob Rosenkrands Sales Director Anders Hunniche Area Sales Manager - Pharma & Biotech ah@alflow.dk Silvia Roma Bentin Internal Technical Sales sb@alflow.dk SINGLE-USE PRODUCTS Silicone tubing Silicone pump tubing High-pressure silicone tubing Single-use fittings Pass-through technology Single-use assemblies Molded filling assemblies Single-use bags Single-use systems Single-use manifolds Sealers Welders Alflow Scandinavia serves the pharmaceutical industry with process equipment. A high level of background knowledge is extremely important in an industry where documentation requirements are high - that s what makes Alflow particularly unique. 25 top professionals are ready to help you with your flow-equipment needs. Alflow Scandinavia Industrivej Vest 36 DK-6600 Vejen T: alflow@alflow.dk