Extractable and Leachable Studies

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.
Experience with:

• Dry powdered inhalers
• Metered dose inhalers
• Nasal spray pumps
• Liquid oral products
• Lyophilized products
• Ophthalmic products
• Parenteral solutions in bags and vialsPrefilled syringes
• Surfaces contacted during manufacture including piping, tubing, flanges and connectors, filters, valves, and single-use disposable bags and containers