Registration Open

Mar 12, 2024 7:00am ‐ Mar 12, 2024 5:00pm

Identification: EU24CEMAR1/SESREG2

Registration open: Tuesday, 12 March 0730-1900 CET. Registration will also be open on Monday, 11 March from 1400-1800 CET.

Break

Mar 12, 2024 10:00am ‐ Mar 12, 2024 10:45am

Identification: EU24CEMAR1/SESBR1


Aseptic101

Mar 11, 2024 3:00pm ‐ Mar 11, 2024 5:00pm

Identification: EU24CEMAR1/SESWS

Aseptic processing is an important part of the pharmaceutical industry, and it can be confusing to know where to start. That’s why we’re holding this introductory session – so you can learn about ISPE, sterile manufacturing methods, and everything else related to aseptic processing. You’ll hear from experts in the field and have the opportunity to ask questions. All attendees are welcome, but this session is tailored more specifically to students, emerging leaders, young professionals, first time attendees, or those needing additional insight into all things Aseptic.

Welcome to the 2024 ISPE Aseptic Conference

Mar 12, 2024 8:30am ‐ Mar 12, 2024 8:50am

Identification: EU24CEMAR1/SESP1


Implementation of Annex 1 - GMP Inspector's View

Mar 12, 2024 8:50am ‐ Mar 12, 2024 9:20am

Identification: EU24CEMAR1/SESP2

Discussion of positive examples and points of improvement in the implementation of Annex 1, with focus on CCS, Pupsit and new technologies. Discussion of inspection findings in Austria and third country inspections.

Revised Annex 1 - fit for future?

Mar 12, 2024 9:20am ‐ Mar 12, 2024 9:50am

Identification: EU24CEMAR1/SESP3

Major changes of Annex 1 compared to previous version. Is the updated Annex 1 fit for future now? What are the most discussed changes, where are hurdles for industry or for GMP inspectorates? A personal view from an inspector.

Welcome from the Conference Chair

Mar 12, 2024 9:50am ‐ Mar 12, 2024 10:00am

Identification: EU24CEMAR1/SESP4


Parametric Release a Smart Way for Sterile Products

Mar 12, 2024 10:45am ‐ Mar 12, 2024 11:15am

Identification: EU24CEMAR1/SES201

Parametric Release is not even an alternative for product sterility tests. It secures a better statistical coverage for the entire batch while it allows to speed up the release process at the same time.  By setting it up right it offers a win win situation improving manufacturers productivity and strengthening patient safety at the same time.  The presentation will invite you into Bipso´s journey towards parametric release, gives an overview about the regulatory background and  elucidates practical aspects and challenges for implementation.

Seal Tightness Drones to Support Container Closure Integrity Assurance

Mar 12, 2024 10:45am ‐ Mar 12, 2024 11:15am

Identification: EU24CEMAR1/SES301

Seal Tightness Drones to Support Container Closure Integrity Assurance|A novel method for monitoring vial sealing and container handling using 'drones' (sensor-enabled replica containers) that measure seal force, pressure, and shock will be explained. This new technology gives insights into the process variability inherent in the capping and crimping process and throughout the filling and packaging process. Data will be shared that focuses on the interrelationships of components and crimping performance. Anticipated applications will be presented including data generated that gives insights into material properties and how they impact seal tightness.

The management of the capping and crimping process for vials has always faced challenges due to the lack of a suitable method to monitor the process with the absence of an in-process analytical monitoring tool. Residual Seal Force (RSF) is sometimes used but adoption of RSF is not uniform in industry due to limitations with reproducibility. Industry practice still often relies on rudimentary checks carried out by operators that are not quantitative. The method under development with project partner SmartSkin to monitor this assembly process will be explained as well as the progress made toward integrating this method as a GMP application. Integrating these new seal tightness measurements into a control plan which supports the holistic approach and assurance of container closure integrity (CCI).


Gloveless Isolators

Mar 12, 2024 10:45am ‐ Mar 12, 2024 12:15pm

Identification: EU24CEMAR1/SES101

Six short presentations that focus on the technical side of gloveless isolators. All of these speakers will return after lunch for a panel discussion on Gloveless Isolators.