Pharmaceutical Aseptic Processing Virtual Summit 2023

Conference Overview

Pharmaceutical Aseptic Processing Summit 2023 overviewing 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.

The featured talks on:

• Annex 1 and aseptic processing - compliance with the guide. Considerations for implementation. Regulatory framework. Aseptic Processing principles. Preparing for regulatory inspections.
• Antibody Drug Conjugates / HPAPIs production: aseptic processing of ADCs / HPAPIs - complying with regulatory requirements, ensuring aseptic fill-finish, empowering cleaning, preventing cross contamination, providing occupational safety.
• Lyophilization of highly potent products and aseptic processing.
• Aseptic process development, validation and evaluation. QRM for aseptic processing. Reviewing main results, challenges and considerations achieved in aseptic manufacturing.
• Aseptic processing simulation: concept creation based on current regulations, process simulation, media fills.
• Pharma 4.0: Innovations and advanced aseptic manufacturing technologies. New ways for manufacturing excellence. Automated Solutions.
• Highly potent facility design and engineering considerations: building safe aseptic production at each stage. Conceptual design, basic engineering, detail engineering, implementation, installation. Equipment and utilities overview, room installation, cleaning and waste management. Creating a new aseptic filling line.
• Isolator Technology use in aseptic processing for loss minimization/elimination. Cycle time reduction.
• Ensuring safe production for both sides (manufacturer and patient) through innovations and data sciences.
• Eliminating operator impact on production via barrier systems. Restricted Access Barrier Systems.
• Robotics use in aseptic processing. Modernisation of the traditional lines. New facility installation. Future, advantages and disadvantages.
• Overcoming technical challenges in decontamination processes and material transfers. H2O2 decontamination – ensuring production robustness.
• Ageing facilities: choosing between upgrade and renovation. Overviewing 2 cases and ways to ensure required aseptic manufacturing.
• Contamination control program- cleaning and disinfection programs for aseptic facilities. Current regulations and guidance. Contamination control principles. Sterility and cleanliness of product/non-product contact surfaces. Ensuring controlled environments though disinfection and cleaning procedures. Validation protocols creation for cleaning systems implementation. Antimicrobial testing.
• Airflow visualization for contamination risks assessment.
• Implementing containment technologies in aseptic processing – step by step strategy.
• Cross contamination prevention and control for highly potent products. VR use for cross contamination prevention.
• Boosting sterilization: successful strategies, advanced technologies implementation. Sterility testing.
• Sterility assurance in aseptic processing using microbial monitoring and advanced techs implementation. Regulations. Environmental monitoring design based on process analysis, risk assessment, new technologies and instruments. Components determination.
• Applying QbD, ICH Q9, risk management to improve aseptic processing and sterility assurance. Aseptic process analysis and QbD based design.
• Cleanroom examination, cleaning and disinfection procedures, mistakes identification. 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.