Extractables & Leachables

What are Extractables & 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?

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


At Aspen Research, our scientists and technical experts have a long history of working with medical device, pharma, biotech and their suppliers as well as suppliers to food companies. Our ability to give you expert advice and analytical solutions makes us the perfect partner to support your  Extractables & Leachables project.


Why Aspen for Extractables & 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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Aspen Research Corporation

8401 Jefferson Hwy, Maple Grove, Minnesota 55369, United States

Phone: (651) 842-6100 ∙ Fax: (651) 842-6199

Business Hours

Monday - Friday 8:00 a.m. - 4:00 p.m.