Jan Fouks Director of Sales Analytical Services Main: (651)792-6231

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Presentation transcript:

Jan Fouks Director of Sales Analytical Services Main: (651)

Overview Established in 1986 (3 Founders: DuPont) New Facility Opened ,000 sq/ft. of total space 25,000 sq/ft. of laboratory space 46 Employees with expertise in Science and Materials 20 Laboratory 20 Engineering/Production 6 Management/Support Accreditations: ISO 9001:2008, ISO 17025:2005 Analytical Lab Testing, R&D Development, and Custom Compounding

Operations Aligned for Success and Agile Market Adaptation  3 Operational Groups aligned for quick and efficient work, precise project management, and greater cost savings.  President: Rick Burnton  Executive Vice President: Greg Patterson  CIPO and General Counsel: Ken Zigrino  Analytical Services: Jerry Olson  Research and Development: Roger Pearson, Ph.D.  Manufacturing: Chris Chapman “Coming together is a beginning; keeping together is progress; working together is success.” ~HENRY FORD Engineering Analytical Testing & Performance Testing Materials Manufacturing

A Culture Like No Other 5 Ph.D. scientists on staff Use of the scientific problem solving approach and a structured project management delivery system Interactive interdisciplinary team approach Network of reliable business partners increases our ability to serve customer needs Disciplines represented at Aspen: Physics Chemistry Metallurgy Chemical Engineering Mechanical Engineering Composites Engineering

Analytical Services ISO 17025:2005 Accredited GLP and GMP Compliant -Trace Analysis -Extractables & Leachables -Pre-Clinical Support -Materials Characterization -Polymer Degradation -Electrochemical Tests -Food Contact Notification -Off Odor Identification -Method Development and Validation

Analytical Project Flow Perform Analytical and Issue Report Methods Used, Results and Discussion10 – 20 days Issue Quote Objective, General Methods, Deliverables, Pricing2 – 10 days Request for Project Existing Method or Method Develop2-5 days

Analytical Capability SEM/EDS (Scanning Electron Microscope) WDXRF (Wave Dispersive X-Ray Fluorescence) GC and GCMS (Gas Chromatography) HPLC-DAD-MS (High Pressure Liquid Chromatography) HPLC-DAD-TOF IC (Anion and Cation Chromatography) ICP/MS and ICP/OES (Inductively Coupled Plasma) TOC (Total Organic Carbon) FTIR (Fourier Transform Infrared) Thermal Analysis: DSC, TGA, TMA, DMA, MFI, RDA Tensile, Modulus, IZOD Impact, Drop Dart, HDT, Vicat Micro Hardness and Rubbers Testing Optical Testing and Measurement Metallurgical Finish Chemistry / Wet and Extraction Lab ASTM F2129: Cyclic Potentiodynamic Polarization

Separations Science GC/MS with multiple inlet capabilities TDS, P&T, SPME, HS, LVSH, Liquid Inject, Cool on Column HPLC DAD/MS (2), DAD-TOF, ELSD, RI, Electrochemical, Fluorescence GPC Ion Chromatography Anion and Cation

Spectroscopy, Elemental, and Electrochemical ICP/MS and ICP/OES WDXRF UV/VIS FTIR Micro reflectance and ATR SEM/EDX Cyclic Potentiodynamic Polarization

Extractables & Leachables Extractables Studies (ISO and GLP) Designed to give comprehensive profile of potential leachables Solvents to choose and extraction times and temps to utilize (Aspen ISO WI-8) ISO , PQRI, USP 467, FCN, ASTM F1884 Provide data for preliminary risk assessment Four ISO SOPs in scope – ICP, IC, GCMS, HS-GCMS Support material selection Meet regulatory expectations Participated in initial ELSIE Studies Leachables Studies Determine concentrations of compounds that do leach into products (pharmaceutical) Requires validated methods

ISO Support Polymer Degradation ISO Electrochemical Tests ISO Materials Characterization ISO

Pre-Clinical Studies Device, Drug/Device, Pharmaceuticals Method Feasibility Studies Extraction procedures Analytical Instrument choice and conditions Method SOP Development Method Validation (GLP) Protocol Development Final Reports GLP Compliant

Food Contact Notification CFSA/Office of Food Additive Safety Guidance for Industry – Chemistry Recommendations EU Regulations 10/2011 The Plastics Implementing Measure Extractions and Analysis Food Type and Conditions of Use – Solvent Type Volume to Surface Area Time and Temperature Trace Analysis utilizing Validated Methods Off Odor Analysis Compliant unless imparts malodor or off taste

Materials Development Lab and Materials Development Fusion Bowl Brabender (small scale singe-screw extrusion) 30mm Compounding Multiple Feed Streams: Liquid, Pellet, Powder, Gas Vacuum / System Vacuum Potential Multiple Material Forming: Hot Face Pellet, Strand Markets Served: Medical, WPC, Adhesive, Polymer Development Injection Molding for ASTM Testing Full In-house materials characterization capability Benefits Material formulations can be fine tuned to optimize feed and through-put Added flexibility and reduced risk Lower cost for development runs Collected results can help assist in sizing up larger operations 58mm and 72mm compounders on site

Metallurgy and Materials 4 Analysts (technician – Ph.D.) 75+ years of experience SEM/EDS, Microscopy, Metal Finish, Cross Section Destructive and Physical Testing INSTRON (Temp Range: -30° F to 300° F) Peel, Puncture, Pull Tear, Tensile, Modulus, Compression Coefficient of Friction IZOD Impact Testing Notched, Un-Notched Drop Dart Various Modes Water Vapor Transmission Ambient to RH Thermal/Mechanical Testing DSC, TGA, TMA, DMA, HDT, Vicat

Materials Testing Capabilities Include (But are not limited to) Color Performance and Color Testing (Fluids, Solids) Internal QUV Exposure Services External Partnership with Atlas DSET Laboratories Accelerated and Static Weathering Xenon Exposure (Accelerated) Locational / Geographic Static Weathering

Experience and Knowledge Industry Experience Medical Device Pharmaceuticals Consumer Goods Food Products and Packaging Transportation Building Materials Industrial Goods Specialty Chemicals Electronics Personal Care and Cosmetics Government and Regulatory

Confidentiality The very essence of business is competition. At Aspen, we are committed to the success of each customer. We understand that your investments and innovations are the seeds of your prosperity. That is why Aspen's policies, security procedures and personnel give high attention to confidentiality, and our careful management of sensitive information is for the benefit of those who provide it or acquire it through our services.

The Aspen Advantage a company that: Enables your company to create customer value quickly and cost-effectively. Utilizes our experience in technology, products and processes to create advantage or solve problems. Has a partnership approach…fills gaps in resources or expertise Brings a fresh perspective. Works with you to implementation and beyond.