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 risk assessments & gap analyses for drug products and/or their 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



Lifecycle Management

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

Get in Touch

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

Get In Touch