Single-Use BioProcess Systems

Transcription

1 Single-Use BioProcess Systems Single-Use Bags 50 ml to 3,000 liters Validated Materials Proven Designs Leading Service

2 Capabilities cgmp manufacturer QSR and ISO 9001:2008 compliant Certified ISO class 7 clean room Validated materials, processes and designs Fast delivery Custom products to meet your timeline 2014 Saint-Gobain Performance Plastics Corporation

3 Single-Use BioProcess Systems Consultative customized solutions Standard product from stock 50 ml to 500 liters Industry-leading materials and components Sterilized by gamma irradiation (SAL 10-6 ) Full validation information Delivery assurance Small Volume Bags 50 ml to 20 liters Integrated handle Integrated hanging capability Needle-free sampling port May be used with sterile welder Available as manifold system Bags for Cylindrical Tanks 50 liters to 750 liters 2D and 3D designs Top or bottom drain Available as liner Recirculation loops Available as manifold system Bags for Rectangle Tanks 50 liters to 3,000 liters Designed to fit your existing tank Top or bottom drain Available with 1" ID tubing Recirculation loops Integrated sampling systems 2014 Saint-Gobain Performance Plastics Corporation

4 For more than four decades, Saint-Gobain Performance Plastics and From Design to Delivery We Provide Quality Products Tailored to Your Exacting Specifications its family of companies have supplied the world with innovative, high-performance polymer products for the most demanding applications. Our tradition of excellence goes back almost 350 years through our parent company, Compagnie de Saint-Gobain, one of the world s top 100 industrial corporations, with operations in 64 countries. This successful corporation has been built with the single purpose of serving the customer and a commitment to quality and leadership in each of the industries served. Contact us today for: Consultations Samples Quotes Orders On-time Deliveries biopharmaceutical products manufacturing facility Saint-Gobain Performance Plastics Highway 55 Plymouth, MN Tel: (763) Fax: (763) IMPORTANT: It is the user s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics materials for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication, or application of the products into which the materials are incorporated. SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. FLS-5158B-PDF-0914-SGCS 2014 Saint-Gobain Performance Plastics Corporation

5 Technical Bulletin Multilayer Film Structure Saint-Gobain single-use bags are constructed of multilayer films optimized for bioprocess production applications. Film materials are consistent throughout the product range, and are certified to be free of materials of animal origin. Offering outstanding biocompatibility, chemical compatibility, barrier and strength properties, Saint-Gobain films meet the most demanding bioprocessing applications. Fluid Contact Layer - Low Density Polyethylene (LDPE) Provides outstanding biocompatibility with broad chemical compatibility for safe handling of a wide range of biopharmaceutical liquids. Gas Barrier Layer - Ethyl Vinyl Alcohol (EVOH) Provides excellent barrier to the transmission of oxygen and carbon dioxide. Strength Layer - Nylon Provides outstanding impact and tear resistance, optimizing overall toughness of the bag. Tie Structure Multiple materials provide bonding between layers and add to overall performance of the bag. Multilayer Film Thickness 50 ml to 1 liter bags: 7 mil 2 liter to 2,500 liter bags: 12 mil Nylon Tie EVOH Tie LDPE Saint-Gobain Performance Plastics Highway 55 Plymouth, MN Tel: (763) Fax: (763) IMPORTANT: It is the user s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics products for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication or application of the products into which the materials are incorporated. SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WARRANTY: For a period of 12 months from the date of first sale, Saint-Gobain Performance Plastics warrants this product to be free from defects in materials and workmanship. Our only obligation will be to replace any portion proving defective, or at our option, to refund the purchase price thereof. FLS-5165a-1113-SGCS Saint-Gobain Performance Plastics Corporation

6 Technical Bulletin Bag Chambers Materials Multilayer film construction with LDPE fluid contact layer, EVOH gas barrier and nylon outer layer. Physical Properties Thickness 50 ml - 1 liter Chamber 2 liter liter Chamber ASTM 1 Units Typical Value N/A N/A mils mils Tensile Strength (MD) D882A psi 5300 Tear Resistance D1922 grams >800 Seam Strength D882 lbs/in >25 Dart Impact D1709 grams >1600 Operating Temperature N/A C -80 to +60 O 2 Transmission Rate F-1927 cc/100 in 2 / 24 hr 0.02 CO 2 Transmission Rate 2 N/A cc/100 in 2 / 24 hr <0.06 (1) ASTM test results reported using 7.0 mil chamber construction (2) CO 2 transmission rate reported using raw material performance data Biological & Particulate Testing Test Protocol Result Cytotoxicity, In Vitro ISO Biological Reactivity, In Vivo (USP Class VI) USP <88> Endotoxin USP <85> Particulate Matter USP <788> EP <2.9> Sterilization Microbiological Validation of 25kGy Radiation Sterilization Test Protocol ANSI/AAMI/ISO Result 10-6 SAL 2 Year Expiry Animal-Derived Components All chamber materials are free of animal-derived components. Polyethylene with Additives for Containers Physicochemical Tests for Plastics Sterile Purified Water (Oxidizable Substances) EP <3.1.5> USP <661> USP <1231> Saint-Gobain Performance Plastics Highway 55 Plymouth, MN Tel: (763) Fax: (763) IMPORTANT: It is the user s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics products for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication or application of the products into which the materials are incorporated. SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WARRANTY: For a period of 12 months from the date of first sale, Saint-Gobain Performance Plastics warrants this product to be free from defects in materials and workmanship. Our only obligation will be to replace any portion proving defective, or at our option, to refund the purchase price thereof. FLS-5166B-0514-SGCS Saint-Gobain Performance Plastics