Extractables and leachables testing
LGC has a wealth of experience in assessing extractables and leachables for a wide range of products, including:
- Pharmaceuticals
- Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.)
- Pre-filled syringes
- Transfer systems (tubing, iv bags, connectors etc.)
- Parenteral, ophthalmic, dermal, topical, orally inhaled and nasal drug products, metered dose inhalers
- Biopharmaceuticals
- Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.)
- Pre-filled syringes
- Transfer systems (tubing, iv bags, connectors etc.)
- Single use systems / process contact materials (tubing, gaskets, filters, bags, o-rings etc.)
- Parenteral, ophthalmic, dermal, topical, orally inhaled and nasal drug products, metered dose inhalers
- Consumer Healthcare
- Container closure systems (plastic/glass bottles, stoppers, laminated tubing, labels etc.)
- Creams, ointments, toothpaste, shampoo
- Medical Devices
- Whole or component parts according to ISO-10993 (Biological Evaluation of Medical Devices)
- Animal Healthcare
- Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.)
- Tags, implants
Techniques
- Solvent extraction including ultrasonication, reflux and microwave
- Headspace GC-MS (Volatile Organic Compounds)
- GC-MS and GC-FID (Semi-Volatile Organic Compounds)
- HPLCDAD- MS/MS (Non-Volatile Organic Compounds)
- ICP-MS (Inorganic Compounds)
- FT-IR, HRAM-MS and NMR (structural elucidation and unknown ID)
Applications
- Screening studies to aid single use manufacturing component, container closure system component, transfer system component or medical device component selection
- E&L studies for regulatory submission
- Managing forced or elective changes in single use manufacturing components, container closure system components, transfer system components or medical device components
- Method development, validation and technology transfer of analytical methods for product testing and quality control
Toxicological Risk Assessment
The data generated by LGC’s E&L studies can be used for toxicological assessment of any specific compounds as part of a human health risk assessment package. We partner with one of Europe’s leading chemical hazard and toxicology risk consultants to provide this service to our customers.
