Aspen Research

Our ISO 9001:2015 / 14001:2015 quality policy: We will deliver quality products with a commitment to customer satisfaction by creating empowered teams focused on innovation to drive continuous improvement in an environmentally responsible manner. We commit to protecting the environment by preventing pollution and eliminating any waste where possible. We will fulfill all of our environmental commitments and quality requirements and will work to continually improve our EQMS.

• ISO 9001:2015 Certificate (PDF)
• ISO 14001:2015 Certificate (PDF)

ISO 17025:2017 is the standard that outlines the requirements for the competence of testing and calibration laboratories. The Analytical Laboratory is accredited for testing specific methods under this standard. The ISO 17025:2017 quality policy is: ARC delivers 100 percent on time, defensible analytical results that our clients can reliably use to solve their problems and enhance their business. (link to certification)

• ISO 17025:2017 Certificate (PDF)

We have extensive experience in polymer analysis and are experienced at designing and conducting appropriate studies to assist with both regulatory and process concerns. Aspen is an ISO accredited laboratory and utilizes ISO 17025 validated test methods when appropriate for extractables testing.

Extractables: Extractables are compounds that CAN be forced to migrate from the contact material into a solvent under aggressive extraction conditions such as extended time, elevated temperature or different solvents. The point of extractables screening is to assess what MIGHT migrate.

Leachables: Leachables are compounds that DO migrate from the contact material into the drug product or medical device under normal conditions of storage. The substances of concern typically come from plastic components, elastomers, coatings, accelerants, antioxidant, inks and adhesives.

What is the Testing Process?

Design and conduct appropriate extractables studies to identify potential leachables from the materials used in the manufacture, storage or delivery of the product.

• Provide written final reports that are clear and easy to interpret and apply
• Validate methods for extractables deemed of concern to apply in the leachables study
• Conduct real time and accelerated leachables studies
• Provide insight as to sources of observed leachables
• Design routine testing programs to assure consistency and quality of supply chain or finished product
• Provide study designs in accordance with the best practice guide issued by the Biophorum Operations Group (BPOG)

What ISO 17025 Test Methods are Used in Extractables Testing?

We have extensive experience in polymer analysis and are experienced at designing and conducting appropriate studies to assist with both regulatory and process concerns. We are an ISO accredited laboratory and utilize ISO 17025 validated test methods when appropriate for extractables testing.

• Headspace (HS)-GC/MS
• GC/MS for volatile and semi-volatile organics
• HPLC-diode array (DAD)-TOFMS for semi and nonvolatile organics
• ICP/MS or ICP/OES for trace metals
• QTOFMS or MS/MS also available to aid in unknown identification
• Other techniques when appropriate

Our testing capabilities enable us to characterize most materials used in the fabrication of products available to the industry and the general public. Mechanical and physical properties, polymer characterization (plastic and elastomeric), product design construction, metallurgical properties, failure analysis, foreign material analysis, trace analysis and compound analysis are some of the many tests that we are able to perform. 

Failure Analysis Testing

The lab conducts failure analysis investigations for a wide spectrum of industries, products and manufacturing processes. We work to identify the failure mode and primary causes for the failure. Root cause investigations are also conducted as needed. 

Polymer Testing

Plastic and elastomeric materials are characterized based on their basic properties relative to their physical, thermal, mechanical, chemical and melt attributes. Our testing provides clients with the information that they need to address material usage pertaining to quality control, alternative supplier selection, failure analysis and more. 

Foreign Materials Testing

We start with visual examinations of the foreign material and acquire photographic records to document its location and appearance, then apply two analytical tools to the project: SEM-EDS and FTIR. 

Metallurgical Testing

In addition to the procedures and techniques employed for all materials, the lab employs the following in regard to metallurgy: 

• Disassembly of products for direct examinations
• Visual examinations and photographic records
• Scanning Electron Microscope (SEM) and X-ray Energy Dispersive Spectroscopy (EDS)
• Metallographic cross-sections
• Image Analysis
• Mechanical Testing
• Bulk Chemical Analysis
• Physical Testing

Mechanical and Physical Testing

The laboratory can be climate controlled in order to properly condition materials that require such an environment. 

Mechanical Testing

• Instron Load Testing
• Impact Testing
• Puncture Testing
• Hardness Testing

Physical Testing

• Density
• Viscosity
• Rheology
• Moisture content
• Vapor transmission
• Color
• Thermal Cycling
• Coating deposit integrity

Areas of Expertise

With decades of experience, we are experts in the following areas.

• Medical device
• Pharmaceutical
• Metals
• Ceramics
• Polymers (resin and molded parts)
• Composites (metal and polymer matrix)
• Rubber
• Liquids – Organic-polar and non-polar
• Liquids – Aqueous-ionic, acidic, basic, neutral
• Chemical Reagents
• Gases
• Paper
• Food Contact
• Film Sheets
• Electronics
• Wood (engineered)
• Food (flavoring, foreign material tramp chemistries)
• Water (treatment and waste)
• Petroleum based products
• Filters

Comprehensive method development and validation can be designed for a full range of analytical techniques. In addition to custom methods, we are experienced at identifying and applying ASTM and USP test methods. We specialize in testing materials for compliance with <661> Containers – Plastics and <1663> Extractables Associated with Pharmaceutical Packaging / Delivery and <1664> Drug Product Leachables Associated with Pharmaceutical Packaging / Delivery Systems. 

USP Testing

The lab performs testing that is compliant with the standards found in the U.S. Pharmacopoeia and National Formulary (USP-NF). USP-NF contains monographs applicable to drug substances, dosage forms, compounded preparations, excipients, medical devices and dietary supplements. Each monograph consists of a series of tests, procedures for performing the test, and acceptance criteria. USP-NF is recognized by the U.S. Food and Drug Administration as its official set of quality standards for drug products within the United States. USP standards are also used in over 140 countries worldwide.

The capabilities with regards to USP testing are dependent upon the material being tested and its applicable monograph. We are experienced with testing materials for compliance with <661> Containers – Plastics. In addition, we have also performed extensive work related to Assessment of Extractables and Leachables and are versed in the guidelines found in USP <1663>  Extractables Associated with Pharmaceutical Packaging / Delivery Systems and <1664> Drug Product Leachables Associated with Pharmaceutical Packaging / Delivery Systems. 

ASTM Test Methods

Navigating the many existing testing agencies in order to identify an appropriate testing procedure can be a challenging task. The expansion of global trade has driven regulatory agencies and quality management systems to define standardized test methods. This ensures accuracy and uniformity of testing, data collection and reporting If needed, we will assist clients in identifying a standard appropriate for their requirements and needs. For example, the standards published by ASTM International cover a wide spectrum of materials, products, systems and services, several of which Aspen periodically conducts.  Click here for a list of ASTM Test Methods which Aspen periodically has used. .

Method Development

Method validation is designed in collaboration with the customer and is based on their specific needs. Validation protocols can be written by our staff using our validation template or they can be provided by the customer. All protocols written the analytical lab are submitted to the customer for approval.

Upon completion of all method development and/or method validations, a comprehensive report is provided to the customer. The report can be customized to meet the specific needs of the customer and can be supplied both electronically and via traditional paper format. The report includes:

• Formalized/detailed analytical procedure of the method developed with supporting data
• A copy of the validation protocol
• Supporting data including graphs and calculations
• Supporting instrumental output such as chromatograms and spectral images

Validated or Custom Methods

The objective of any analytical method is to secure test methods which are reproducible and accurate. This is done to provide objective evidence that the test method is specific for its intended use. Depending on the client’s requirement, method validation maybe required. The validation of a test method demonstrates that the method is fit for its intended purpose. We have the capability to develop new test methods, as well as perform method validation.

Food Contact

All materials that come in contact with food should be tested to ensure that they are safe. Additionally, packaging must be functioning optimally to maintain the integrity and quality of its contents. We can customize testing that is unique to your product and packaging and the situations that they present. 

Migration

Migration is the process of compounds leaching from the packaging into a food or beverage. While there are many plastic compounds that are approved for use as a food contact material, they are still subject to Food Contact regulations. For plastic materials, two types of migration limits have been established in Commission Regulation (E.U.) No.10/2011. The Overall Migration Limit (OML) applies to the sum of all substances that can migrate from the food contact material to the food. This is a measure for the inertness of the material. A Specific Migration Limit (SML) applies to an individual substance and is based on toxicological studies. The presence of these substances in food is identified by analytical techniques. All packaging is capable of leaching chemicals into food products. While plastics are often the culprits, paper, foil, glass and ceramic containers can also permit migration. Sometimes, it may be a seal or the liner that must be tested.

Off Odors

Our laboratory can identify what ingredients in your product are giving off unwanted chemical odors. After an assessment of underlying key indicators, we  will design the appropriate testing strategy for your unique situation.

Offgassing

Offgassing (or Outgassing) is a natural process of releasing volatile chemicals from many manufactured products. Making sure that these substances are safe for humans is critical. These studies are designed to determine what compounds and their concentrations volatilize from a material under variable conditions of time and temperature.

We have a diverse array of analytical instrumentation to address clients’ questions relating to materials used to fabricate their products. We work with all our clients to select the pertinent analytical platform(s) necessary to ensure they have the requisite data needed to make successful business decisions.

Equipment by Platform

Chromatography

• IC (anions, cations and weak organic acids)
• HPLC/ECD
• Preparation HPLC
• LC/MS
• GPC
• HPLC-DAD-TOFMS
• HPLC Q-TOF
• HPLC (triple quad)
• GC/FID
• GC/TCD
• GC/MS
• GC/MS with Frontier multishot
• EGA/Pyrolizer-3030D
• GC/MS with Gerstel TDS
• GC/MS with Large volume sampler
• GC/MS with HS auto sampler
• GC/MS with PAL system (multi-tools for liquids, HS and SPME analysis)

Metals Analysis

• ICP-OES
• ICP-MS
• WDXRF, Rigaku Supermini 200
• EDS, Noran, Light Element Detector and Beryllium Window

Moisture

• Karl Fischer, Mitsubishi Coulometric with oven attachment
• Computrac, Arizona Instruments Vapor Pro

Materials Characterization

• HP UV-Visible Diode Array Spectrometer
• TOC, Tekmar Dohrman Phoenix 8000 Analyzer
• Princeton Applied Research (ASTM F2129, Cyclic Potentiodynamic Polarization)
• FTIR (Thermal Nicolet with Microscope, Diamond ATR capabilities)
• Gas Pycnometer, Micromeritics AccuPyc 1330
• Contact Angle, PGX Pocket Goniometer
• Particle Size Analyzer, AccuSizer 780, USP 788

Imaging

• Digital Photography
• Polarized Light
• Optical Microscopy with Digital Camera
  • Stereo up to 40X
  • Reflected Light 50X to 1,000X, Bright Field, Dark Field & Polarized
  • Transmitted Light 50X to 400X, Bright Field & Polarized
• SEM, Hitachi S-3000N, Variable Pressure
• Image Analysis

Viscosity Analysis

• Brookfield cone & plate (low viscosity)
• Brookfield cone & plate (high viscosity)
• Brookfield LVT

Mechanical Testing

• Instron (tensile, elongation, modulus, flexure)
• Ceast MFI (melt flow index)
• Ceast HDT (heat deflection temperature)
• Ceast VICAT (softening temperature)
• Gardener Impact Tester
• Atlas Dart Drop Impact Tester
• Rockwell Hardness Testers (All Scales)
• Micro Hardness Tester, Shimadzu (Knoop and Vickers, 15-1000 gram)

Thermal Analysis

• DSC (differential scanning calorimetry),TA Instruments
• TGA (thermal gravimetric analysis), TA Instruments
• TMA (thermomechanical analysis), TA Instruments
• DMA (dynamic mechanical analysis), TA Instruments

Rheology

• Ceast Capillary Rheometer
• Rheometrics Dynamic Analyzer, RDA-II, parallel plate