Search results with tag "Sterile filtration"
Chapter 14 Sterile Filtration, Filling, and Lyophilization ...
biomanufacturing.orgAseptic: 1) without (free of) disease-causing microorganisms 2) preventing infection; designed to prevent infection from pathogenic microorganisms Aseptic processing: the process by which a sterile product (typically pharmaceutical) is packaged in a sterile container in a way that maintains sterility
active substance, excipient and primary container ...
www.ema.europa.eusterile filtration in most cases is followed by at least one aseptic processing step such as filling. In order to focus on the most important aspect of filtration and aseptic processing at each section of this guideline, only one of the two steps may be mentioned, even if both steps are related.
Basic Requirements For Aseptic Manufacturing Of Sterile ...
www.dgra.demonitoring, sterile filtration and validation by media fill) along with the base of these requirements, keeping in mind the differences between Europe and USA. The outlook will present a rational approach to the complete qualification (rooms, equipment, supply systems, materials etc.) and validation with the help of HACCP (Hazard Analysis and
Questions and answers on the principles of GMP ... - Europa
www.ema.europa.eumaterial before sterile filtration and possible microbial growth during this hold time. Otherwise relevant provisions of chapter 9.5 “aseptic manufacturing” of the Part IV GMP guideline should be followed. The manufacturer should justify the applicability extent using …