Aseptic Processing Technology event will overview regulatory updates and their implementation, main challenges and overcome consideration, new technologies and innovations to avoid mistakes and ensure safe highly potent aseptic production for both sides - manufacturer and patient. This event will help you improve your aseptic processes and address contamination control issues that you may encounter.
The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic manufacturing such as ATMPs, pragmatic barrier system applications, adaptability and modularity in fill finish, robotics and automation, small and agile product manufacturing, just to name a few. In 2018, the global aseptic processing market was valued over $56 trillion and is estimated to increase in net revenue upwards $124 trillion by 2027, with a CAGR growth of 9.18%.
At the event you will have the opportunity to discourse and to network with peers involved in pharmaceutical manufacturing, aseptic fill and finish, quality control, engineering, and container development. Key topics in Aseptic Processing will be discussed by some of the industry’s leading lights.
During this event, you will learn about environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation, and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, aseptic technique qualification, aseptic process simulation, and microbial identification.
Key Practical Points
- The Evolution of Aseptic Technologies
- Multi-Product facilities
- Regulatory framework. Aseptic Processing principles.
- Antibody Drug Conjugates / HPAPIs production
- Lyophilization of highly potent products and aseptic processing.
- Occupational safety requirements
- Aseptic process development, validation and evaluation.
- Aseptic processing simulation
- Highly potent facility design and engineering considerations
- Isolator Technology use in aseptic processing for loss minimization/elimination.
- Overcoming technical challenges in decontamination processes and material transfers.
- Cleaning and disinfection programs for aseptic facilities.
- Microbiology concepts and techniques
- Cross contamination prevention and control for highly potent products.
- Robotics in aseptic processing
- Gloveless Isolators and dose control
- Final fill with SU Equipment
- ADC/HPAPI aseptic processing fill and finish
- Challenges for manufacturers in cell and gene therapy production systems
- Airflow visualization for contamination risks assessment.
- Implementing containment technologies in aseptic processing
- Boosting sterilization: successful strategies, advanced technologies implementation.
- Cleaning automation and technologies.
- Gowning: procedures, training, personnel qualification.
- Microbiology techniques use in aseptic processing.
- Integrating sanitization techniques to empower contamination control.
- Filtration: filter integrity testing in aseptic processing.
- Single-use systems implementation.
- Assess airflow visualization to limit risk for product contamination
- Describe the importance of filter integrity testing for aseptic operations
- Cleanrooms for the Annex 1 updates
- Implementation of quality risk management
Who should attend?
Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical/biotechnology industry / industries involved in:
- Bioprocess Research
- and Development
- Container Development
- Drug Development
- Fill and Finish
- Medical Devices
- Packaging and Labelling
- Pharmaceutical Process and Technology
- Process Monitoring and Control
- Process Analytics
- Product Innovation
- Risk Management
- Regulatory Affairs
- Standardisation Science
- Vaccine/Antibody/Cell Manufacturing
Exhibitors & Sponsors
For over 20 years Novatek International has focused on reducing the risk of non-compliance for pharmaceutical manufacturing companies. By providing software solutions that prevent down-time and product recall, as well as improving product reconciliation. Ultimately, such solutions boost patient safety by ensuring product and data-integrity.
We provide comprehensive business-ready quality process management applications that are fully compliant with all regulatory requirements.
Our main areas of expertise are: Contamination Control, Quality Execution and Quality Process Management.