E&L(용기적합성)
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What we deliver to our E/L customers:
Tailor-made extractables and leachables studies for all types of container closure systems and packaging materials, process equipment or medical devices including printings and adhesives according to MFDS, EMA and FDA requirements
Consultancy for E/L studies in all phases of drug or device development of, e.g. evaluation and assessment of already available E /L data, gap analyses
Toxicological assessment of the results of extractables and leachables studies
Validation of analytical methods for leachables studies (according to GMP)
Interaction studies for APIs with the packaging materials (according to GMP)
Additive analysis in all types of polymer
Assessment & analyses of process materials
Structural elucidation of unknowns
Seminars and training on extractables & leachables
Our Experts
Our centre of excellence for cGMP-compliant extractable and leachable services is located in Reinach close to Basel (Switzerland).
Our experts have specialized in analytical support for the pharmaceutical and medical device extractables / leachables and have over 30 years experience in this field coupled with an extensive knowledge of the polymer and packaging industries.Consultancy for E/L studies in all phases of drug or device development of, e.g. evaluation and assessment of already available E /L data, gap analyses
E/L study of Container Closure System
Prefilled syringe
Glass vial and rubber stopper
Infusion bag
Transdermal patch
Process contact materials (e.g. silicon tubing, bag, filter)
Plastic bottle for eye drop
Disposable bag or plastic bottle for drug substance storage
Medical devices
Secondary/tertiary package (e.g. label, paper box, pouch)
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Extractables / Leachables Toolbox
Intertek uses advanced analytical equipment to characterize both organic and inorganic elements and compounds:
GC/MS: thermodesorption, headspace, liquid injection
HPLC: LC-DAD, LC/MS, LC/MS/MS (ESI and APCI)
MS: EI, CI, high resolution, commercial and in-house mass spectral libraries
Elemental using and quantiative determination X-ray fluorescence, ICP-AES or ICP-MS
TOC determination in aqueous extract
Modern tools for structural elucidation and absolute quantification (1H-, 13C-NMR, FTIR, UV, LC-HRMS, GC-HRMS, prep-LC/MS)
Reference standards (commercial + in-house synthesized)
Other service
Particles Matter Investigation
GMP and CMC Laboratory Services
Our Partner
QBD (Quality by Design Inc.) is working together with us.