In Fill Finish (FF) you will find representatives of the world’s top sterile filling operations developing solutions to some of the most intractable technical and regulatory challenges. Members are now rolling out industry approaches to environmental monitoring and particle risk management; working together on rapid micro adoption and reconciling some of the critical challenges that Annex 1 brings to final filtration integrity testing and isolator disinfection.
The FF mission is to develop and implement best practice processes in drug product operations.
FF collaborates to develop and implement safe, predictable, lean and agile processes in drug product operations that biopharmaceutical pipelines need now and into the future and has strong representation of the top sterile filling operations in the world, both drug manufacturers and CMOs.
The current FF collaboration program is targeting a number of transformational operational improvements. While some of these benefits are easy gains for members, they also recognize that in our regulated environment it makes sense to move together. For this reason, in many cases companies plan synchronized adoption to change the landscape that regulators see across the industry in one go.
- Alternative and Rapid Microbiology Methods
- Container Closure Integrity
- Environmental Monitoring
- Sterile Filtration Quality Risk Management (PUPSIT)
- Visual Inspection and Particulate Control
- Application of Robotics in Filling
- In-Line Monitoring & Real-Time Release
- Isolator Good Operating Practices
- Secondary Packaging
- Reducing barrier breaks and isolator operating costs by optimizing settle plate use and even replacement with new rapid micro technologies; and reducing time to release with rapid sterility systems
- Harmonizing on the best biopharmaceutical environmental monitoring (EM) practices, to ensure the very best control and investment with the right amount and location of monitoring in existing and new facilities
- Reducing lyophilization scale-up and transfer times, and allowing for better optimization of lyo cycles and freeing-up capacity by making the application and use of mathematical models a reality at commercial scale
- Reducing particle contamination of conventional elastomeric stoppers, by promoting a strong industry voice and engaging with suppliers and other parties in a constructive way
- Providing clarity and confidence on particle classification by product type for visual inspection operations, with the use of a new harmonized risk based methodology.