HEALTHCARE Single - Use Systems CONTRACT MANUFACTURING SOLUTIONS PARTNER

Transcription

1 HEALTHCARE Single - Use Systems CONTRACT MANUFACTURING SOLUTIONS PARTNER

2 ASI (A Part of Thermo Fisher Scientific) is dedicated to providing innovative and cost effective solutions to the Life Sciences and Healthcare Industries. Medical OEMs have trusted ASI for over twenty-five years to design and manufacture solutions for the medical device, diagnostic and drug delivery markets. The company partners with its customers to develop solutions, which are safe, innovative and cost competitive. ASI s success comes from its experience to integrate design and manufacturing to deliver low cost, high quality solutions. ASI exceeds the standards of the ISO 13485:2003 Certification, FDA Registration and cgmp for the best results for our customers and the patients they serve. 2

3 CONTRACT MANUFACTURING SOLUTIONS PARTNER ASI s strong background in engineering and manufacturing gives us the ability to design unique products that can be manufactured efficiently. ASI s CORE CAPABILITIES Strong Quality Management System Product and Supply-Chain Management Custom Bags, Tube Sets and Assembly Broad Range of Molding Processes State-of-the-Art Automation Packaging and Sterilization Services Millersburg, Pennsylvania Matamoros, Mexico HEALTHCARE Single - Use System 3

4 CAPABILITIES PROJECT MANAGEMENT DESIGN AND PROTOTYPING MOLDING FLUID MANAGEMENT MANUFACTURING 4

5 QUALITY ASSURANCE QUALITY MANAGEMENT SYSTEMs The Quality Assurance Team at ASI combines their expertise and training with advanced tools such as an award-winning Enterprise Resource Planning (ERP) Software Program and a custom-tailored Quality Management System. These resources and professionals are the reasons ASI has a long-standing successful record of compliance through regular internal and external audits. In addition, ASI utilizes its proprietary E-Ordering System which utilizes bar coding for inventory control and product tracking throughout the manufacturing process; providing complete product traceability from receiving to shipping. The system also generates a custom Certificate of Conformance for every shipment. REGULATORY SUPPORT The Quality and Regulatory Compliance Team at ASI ensures compliancy with FDA and Global Regulations. ASI provides assistance in the filing of 510(k)s and assists in the regulatory assessment of product changes. Sterilization ASI oversees the sterilization of your product via Third Party Certified Sterilization Agents. Our validated irradiation process ensures each product meets and exceeds the highest industry standards regarding sterility and validation. ASI s Quality Management Systems Provides: Six Sigma Methodology to Track and Trend Various Metrics Environmental Monitoring in all Clean Rooms and Warehouses Lot Traceability: Material and Labor Equipment and Tooling IQ, OQ and PQ Supplier Qualification Raw Material Compliance Material Review Board MATURE PROGRAM TRANSFERS PACKAGING REGULATORY SUPPORT STERILIZATION SUPPLY-CHAIN MANAGEMENT QUALITY MANAGEMENT HEALTHCARE Single - Use System 5

6 PRODUCT AND PROJECT MANAGEMENT Our Product Managers collaborate with the Engineering, Customer Service, Quality Assurance, Regulatory Compliance and Purchasing Teams to coordinate every detail of your project from concept phase to final product. SUPPLY-ChAIN MANAGEMENT Creating a seamless flow of supply and production, ASI manages the entire supply chain for our customers. This management includes the purchase of raw materials, supplier compliance records and documentation, inventory and shipping. As an extension of Quality Assurance, all raw materials are inspected and suppliers are routinely audited. ASI has an extensive network of suppliers, which gives us access to nearly any component across the globe and early introductions to the latest innovations. These long-standing supplier relationships keep our prices competitive and our lead-time short. CUSTOMER CONFIDENTIALITY Customers place their trust in ASI to not only develop solutions, but also to maintain a strict level of confidentiality of their Intellectual Property. To ensure that confidentiality, ASI signs Non-Disclosure and Confidential Disclosure Agreements with all customers, suppliers and employees. 6

7 DESIGN AND PROTOTYPING The Engineers and Designers at ASI build long-term value into the first design, creating a product that will flourish from concept to delivery and even as the product matures. ASI combines the advantages of technology with the ingenuity of our engineers to create products that are innovative and functional. ASI s Strong, In-House Engineering Support Team Assists in: Product Design IP Support Exceptional Material Knowledge and Selection Risk Analysis and Mitigation Expert Tooling Development With the foundations of the designs in place, prototypes are made to confirm that the final product will meet its intended specifications and can be manufactured. Some of the Technologies ASI Uses: 3-D Solid Electronic Modeling Animation Component Clearance Calculations Stereolithography Hard Steel Prototype Tooling HEALTHCARE Single - Use System 7

8 AUTOMATION AND ASSEMBLY One of the key elements to a successful program is speed to market. ASI strikes a balance between fully automated machine precision and the care from specially trained assembly technicians. High volume production requires high-speed automated equipment that is fine-tuned to manufacture unique product designs with speed and precision. ASI can direct the design and fabrication of equipment specifically for your product combining external resources with our in-house, fully equipped machine shop. ASI s Assembly Capabilities Include: Manual Assembly and Automation Solvent and UV Bonding Ultrasonic Welding Fixture and Jig Design Bar and Tray Sealing Laser Engraving Robotic Equipment UV and Visible Light Curing Tunnels 8

9 Fluid Management Single-Use fluid management systems are used in a wide range of applications within patient-care specialties. ASI s flexibility results in the best combination of materials, characteristics and designs for our customer s applications. Bags can be made from Polyethylene (PE), Polypropylene (PP), Ethyl Vinyl Acetate (EVA), Poly Vinyl Chloride (PVC), Fluorinated Ethylene Propylene (FEP) or Foil medical grade films. Standard and custom configurations are available ranging from 50 ml 2-Dimensional bags to 3,500 L 3-Dimensional bags. Side or face ports can also be selected per the application. ASI offers an extensive selection of components and tubing sets from our in-house inventory. We will also purchase specialized materials when necessary. Components can be injection molded to your specifications in our molding operation. Bag Manufacturing Capabilities RF Heat Sealing RF Tool Design and Fabrication Impulse Heat Sealing Induction Heat Sealing Hot Stamp Printing Bar Code Printing and Serialization Twenty-Five Bag Films A Selection of 150 Tubing Options Manages Over 10,000 Product SKU s per Year Product Integrity Testing Specially Trained Technicians and Operators ASI takes pride in the ability to deliver results that fit your process. From custom bags and tubing sets to more sophisticated systems, ASI can deliver fluid management solutions to complete your project on-time and on-target. HEALTHCARE Single - Use System 9

10 PRECISION MOLDING Our complete, in-house injection molding solutions provide precise, consistent manufacturing performed by specially trained technicians and state-of-the-art electric presses. Our Quality Management System, award-winning ERP System and FactoryTalk Software integrates job requirements and machine data to ensure each job is completed to exact specifications and within the validated parameters. ASI s Precision Molding Capabilities Include: Conventional Insert Molding Over Molding Multi-Shot Molding Two-Shot Molding Presses from Tons Fully Automatic, Dust-Free Material Loading Area Low and High Volume Production 10

11 Mature Program Transfers What makes ASI a successful single-source partner comes from our ability to bring new solutions to mature products. Customers choose ASI to optimize mature products that require additional manufacturing space, new innovations or additional margin. Experienced Engineers and Program Managers will evaluate your product and identify improvements that create sustainable value for your company and your customers. The scope of our evaluation process includes quick improvements, long-term redesigns, supply-chain management and product life cycle management. ASI can alleviate the manufacturing limitations that challenge mature products by program transfers to our manufacturing centers in the United States and Mexico. The two facilities offer a combined footprint of over 120,000 square feet of space including six ISO Class 7 Clean Rooms and an ISO Class 8 Clean Room. 25 Years of Proven Success High and Low Volume Assembly Standard and Custom Bags, Tube Sets and Sterile Packaging Product and Supply Chain Management State-of-the-Art Quality Management System HEALTHCARE Single - Use System 11

12 ASI AT A GLANCE WE DESIGN AND MANUFACTURE EXCELLENCE ASI (A Part of Thermo Fisher Scientific) is a contract manufacturer of Class I and Class II Single-Use Medical Devices for the medical, diagnostic and drug delivery markets. For over twenty-five years, customers around the globe have trusted ASI to develop and deliver solutions that are safe, innovative and cost competitive. Our success comes from our ability to integrate design and manufacturing to deliver low cost, high quality solutions. Thermo Fisher Scientific 163 Research Lane, Millersburg, PA ASI (A Part of Thermo Fisher Scientific) is an FDA Registered, ISO 13485:2003 Certified Manufacturer MK