Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and is required by regulators to demonstrate the aseptic capability of such processes. A successful program of APS and aseptic manufacturing requires significant operator training, skills, and...
Best & Brightest Aseptic Content from the 2021 Conferences 33 Presentations Featuring 18+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from...
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its...
Online Live Overview Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex...
How will the new EC GMP Guide Annex 1 impact the future of aseptic processing? What are some of the latest developments in barrier/isolator technology? Jörg Zimmermann, 2020 ISPE Aseptic Conference Chair, Vice President...
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key...
Aseptic processing of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. Join us along with federal and state regulators at the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference on 25 – 27 September, at the...
The Interactive Regulatory Panel session at the end of the 2019 ISPE Aseptic Conference is one of the most popular conference sessions each year, and the 19 March session at this year’s conference was no exception.
Tremendous advances in aseptic processing technology have been made and many operations have been modernized, said Richard Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality, FDA/Center for Drug Evaluation and...
