Check out our Analytical Lab Services and Specialties Below.

What are Extractables and Leachables?

Extractables

Extractables are compounds that CAN be forced to migrate from the contact material into a solvent under fairly 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 Aspen Testing Process?

Design and conduct appropriate extractables studies to identify potential leachables from the materials used in the manufacture, storage or delivery of your 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. Aspen is an ISO accredited laboratory and utilizes 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
  

Why Aspen for Extractables and Leachables?

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.

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Our testing capabilities enable us to characterize most materials used in the fabrication of products available to 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

Aspen 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

Aspen characterizes basic properties of plastic and elastomeric materials 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 or reverse engineer a competitor’s material.  

Foreign Materials Testing

Aspen starts with visual examinations of the foreign material and acquires photographic records to document its location and appearance. It then applies two analytical tools to the project: SEM-EDS and FTIR. 

Metallurgical Testing

In addition to the procedures and techniques employed for all materials, Aspen 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

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

Areas of Expertise

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

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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

Aspen Research 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.

Aspen’s capabilities with regards to USP testing are dependent upon the material being tested and its applicable monograph. Aspen is experienced with testing materials for compliance with <661> Containers – Plastics. Aspen has also performed extensive work related to Assessment of Extractables and Leachables and is 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, Aspen 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 for its clients. Click below for a list of ASTM Test Methods which Aspen periodically has used for its clients.

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 by Aspen 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. Aspen has the capability to develop new test methods, as well as perform method validation. 

ASTM Methods Utilized by Aspen

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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. Aspen can customize testing that is unique to your product and packaging and the situations that they present. Partnering with a laboratory such as Aspen can help you to safely and effectively package your product while minimizing cost and helping to protect and grow your brand.

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, Aspen 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.

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Aspen has a diverse array of analytical instrumentation to address clients’ questions relating to materials used to fabricate their products. We work with all  of 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

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You Need an Expert in the Courtroom

 Aspen’s Ph.D. Scientists are experienced at providing litigation support and expert witness testimony. Our quality testing and reporting methods enable us to provide the documentation and present it in a way that it will be easily understood in a courtroom.

You can count on Aspen to provide confidential testing and reporting. Our secure facilities and sample receiving and storage process will give you peace of mind that your case will be handled with the greatest care. Aspen can be called upon to help you with patent infringement, foreign contaminant identification, product failure, and insurance claims cases.

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