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+44 (0) 1223 756577 , +44 (0) 7841 647537 contact@extlesolutions.com

Extractables and Leachables Support for Pharmaceutical Products

ExtLe Solutions Limited provides Extractables and Leachables support to the API / drug product development process.

We provide:

  • Full or partial E&L project management for ALL drug product types, including OINDPs, biopharmaceuticals & parenterals
  • E&L assessments & gap analyses for drug products and/or their manufacturing processes
  • E&L risk assessments & gap analyses for drug products and/or manufacturing processes
  • Full design & management of product appropriate E&L studies
  • USP/PQRI/BPOG aligned regulatory support as appropriate

Depending on the requirements of our clients, the studies we design align with appropriate regulatory guidance documents, including but not limited to:

  • USP <1663> – Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems
  • USP <1664> – Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems
  • USP <1664.1> – Assessment of leachables in OINDPs
  • PQRI guidance – Safety Thresholds & Best Practices for Extractables & Leachables in OINDPs
  • BioPhorum Operations Group (BPOG) Best Practices Guides

Select the type of support you require from the options below

We support single use system (SUS) components including:

  • ​Manufacturing / mixing / storage bags
  • Disposable process filters
  • Diafiltration / ultrafiltration membranes and cassettes
  • Transfer / filling lines
  • Connectors

We support the following drug product device types:

  • DPIs & MDIs
  • Intranasal pumps
  • SVPs & LVPs
  • Pre-filled syringes
  • Autoinjectors
  • Ophthalmics
  • Topicals
  • Transdermals
  • Blow fill seal nebules

Ready To Talk?

If you're ready to discuss your requirements and would like to arrange a call with us click the button below, otherwise if you have general questions or comments please don't hesitate to get in touch

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