Aspen Research CorporationOur Vision is to help you realize yours

Jan FouksDirector of Sales Analytical ServicesMain: (651)792-6231jan.fouks@aspenresearch.com

Overview• Established in 1986 (3 Founders: DuPont) • New Facility Opened 2012• 100,000 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 ServicesISO 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 ReportMethods Used, Results and Discussion 10 – 20

days

Issue QuoteObjective, General Methods, Deliverables, Pricing 2 – 10 days

Request for ProjectExisting Method or Method Develop 2-5 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 17025 and GLP)

• Designed to give comprehensive profile of potential leachables• Solvents to choose and extraction times and temps to utilize (Aspen ISO 17025

504-WI-8)• ISO 10993-12, PQRI, USP 467, FCN, ASTM F1884

• Provide data for preliminary risk assessment• Four ISO 17025 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 10993 Support• Polymer Degradation• ISO 10993-13

• Electrochemical Tests• ISO 10993-15

• Materials Characterization• ISO 10993-18

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 DevelopmentLab 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 Materials4 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 100°F @90% RH

• Thermal/Mechanical Testing• DSC, TGA, TMA, DMA, HDT, Vicat

Materials TestingCapabilities 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 KnowledgeIndustry 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.