Rubrik: Maschinen- und Anlagenbau
(Treffer aus TechnoPharm, Nr. 02, Seite 98 (2016))
GMP risk based environmental control and process monitoring for aseptic processing / Drinkwater • Aseptic processing · Drinkwater J · Franz Ziel GmbH, Billerbeck
risk based environmental monitoring aseptic processing trend metrics Control measures should deliver risk mitigate to acceptable levels, recognising all risks cannot be avoided but can be managed. There are difficulties however setting control measures because new product types – including new biological products – have unique processing challenges ( fig. 1 ) with increasing requirements for cross contamination control, and new technologies for manufacturing and environmental monitoring e. g. single use/disposable systems and Rapid Micro Methods (RMM). Contamination and cross contamination control starts with good process design and today it is better to engineer solutions which do not allow an operator to ...