Assessment of extractable and leachable compounds is an analytical imperative, one that ensures the overall quality of the drug product is not impacted by its packaging system, in-use componentry, or manufacturing train. Alcami understands this fundamental course of testing and analysis is an important aspect of any new drug product or device submission and an important milestone on the critical path to drug commercialization.
Our scientists have a thorough working knowledge of plastics, rubber, and elastomeric materials, those compounds most frequently used in today’s pharmaceutical manufacturing, packaging, and delivery technologies. Equipped with a wide range of compliant qualified instrumentation and working under cGMP guidelines, Alcami’s analysts are able to perform timely, efficient trace analysis necessary to support your applications and speed them to market.
Alcami’s expertise includes the assessment of a broad variety of drug products, routes of administration, and manufacturing system components. A proper assessment includes studies to not only understand which compounds have the ability to leach into the drug product, but also studies to identify which compounds the drug product may extract from the surfaces it contacts.
Innovation in extractables and leachables is arriving quickly and there are many new drug delivery devices and primary packaging materials to be considered and consequently assessed for their risk:
- Dry powdered inhalers
- Metered dose inhalers
- Nasal spray pumps
- Liquid oral products
- Lyophilized products
- Ophthalmic products
- Parenteral solutions in bags and vials
- Prefilled syringes
- Surfaces contacted during manufacture including piping, tubing, flanges and connectors, filters, valves, and single-use disposable bags and containers