PAT and design science
2007 (English)In: European Pharmaceutical Review, no 3, 74-80 p.Article in journal (Refereed) Published
Process analyties. technology (PAT) and mechanical design science are interconnected. This article describes how a well-established design modelling approach. The Hubka-Eder model, is applied to the concepis of PAT end quality by design (QBD). The model connects PAT With quality management concepts as defined for PAT by lhe ICH guldelines for quaiity issues. Examples are taken fom biopharmaceutical applications. but lhese are also applicable to other pharmaceutical ingredients (API). Benefits of using a conceptual design modelling approach on PAT and related subjects are discussed and suggestecl as a complementary functionality analysis tool in PAT and quality design pharmaceutical processes.
Place, publisher, year, edition, pages
2007. no 3, 74-80 p.
Engineering and Technology
IdentifiersURN: urn:nbn:se:liu:diva-21073OAI: oai:DiVA.org:liu-21073DiVA: diva2:240511