List view / Grid view

Whitepapers/App Notes/Posters

Brochures: Extractables & leachables services

19 February 2020 | By

Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.

Whitepaper: Complex Generic APIs: A Primer

20 December 2019 | By

The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.

Application note: Cost review of water for injection systems

19 December 2019 | By

Vapour-compression-based WFI production has a total cost of ownership that is less than or equivalent to that of a membrane-based system and significantly less than that of a typical multiple-effect-based system. The following whitepaper provides examples that illustrate system designs that are relatively basic, yet typically sufficient.