Performing testing to USP standards enables our clients to demonstrate regulatory compliance for their drug products and medical devices.
These tests include:
- USP <1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact
- 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 <232> (Elemental Impurities)
- USP <381> (Elastomeric Closures for Injections)
- USP <661> (Containers – Plastic)
- USP <661.1> Plastic Materials of Construction
- USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
- USP <665> Plastic Components and Systems Used in Pharmaceutical Manufacturing
- USP <671> (Containers – Performance Testing)
We can tailor a bespoke testing programme around your requirements, and can combine our USP testing with a variety of other medical device testing services such as device testing, packaging testing or transit studies.
Contact us to find out more >