Aseptic

Figure 1: Points to consider when designing the media fill study.
Technical
Validation of Aseptic Processes Using Media Fill
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 supervision; thorough maintenance; effective cleaning and disinfection; significant oversight of every...
2021 ISPE Best of Pharma Series: Aseptic Banner
Training

2021 ISPE Best of Pharma Series: Aseptic

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...
Tracking the Journey of Barrier Technology
Features
2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology
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 key results, which were first shared at the
Online Live Training
Online Live

Aseptic Processing and Annex 1 Online Live Training

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...
Video

Explore Aseptic Hot Topics in 5 Questions

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...
Video

2019 ISPE Aseptic Conference: Robotics Highlights

Chairs of the 2019 ISPE Aseptic Conference share a preview of robotics discussions to be featured throughout the educational agenda.