A3P Aseptic processing

This presentation will address the role of endotoxin testing in sterile drug products, regulatory requirements for endotoxin testing as well as current and future trends in endotoxin testing with the focus on transition to animal-free sustainable methods.

The business case for Pharma 4.0™ Pharmaceutical companies have begun to explore new technologies and digital tools to improve their operations with digital technologies such as advanced analytics, machine learning and digital twinning. Digital twinning brings together data, models and business processes. Using digital technologies such as the Internet of Things (IoT), artificial intelligence (AI), machine learning, and managing business processes with software automation applications as well as devices. Aiming at production processes, quality control, supply chain and customer service. The aim is to achieve greater operational efficiency, improved quality control and, not least, greater flexibility in these processes. Advanced digital technologies can dramatically reduce the time it takes to identify and resolve (quality) issues, improving efficiency and effectiveness. Modern contamination control according to the revision of EU GMP Annex 1 It is important for pharmaceutical companies to have robust systems in place to prevent non-compliance and to address any issues that do arise in a timely and effective manner. Business process automation with systems such as; Environmental, Utility monitoring and Cleaning Validation. Trending and statistical analysis are perhaps the most important digital tools for quality control in the pharmaceutical industry. Allowing to analyse and draw conclusions from data. It identifies relationships and patterns in data that may not be immediately apparent and can be used to make predictions and informed decisions, supporting root cause analysis and corrective actions. Benefits of digitalization Process-based business software applications (vertical applications) are designed to support and automate specific business processes, such as the quality control process. They have many advantages over the use of horizontal applications (such as ERP or a generic LIMS): 1. Implementation efficiency: These applications are purpose-built and therefore require less time and effort to implement, resulting in a faster return on investment. 2. Increased accuracy: Because they are built for purpose (a specific business domain), they lead to improved accuracy, increased efficiency and risk mitigation. 3. Better collaboration: Process-based business software applications include tools for improved collaboration, such as task management, planning and scheduling, which ensure that employees work more effectively and lead to a reduction in operational errors. 4. Improved data management: Storing and organising data for specific purposes, ensuring better insight. 5. Improved compliance: Ensure compliance with regulations and standards by automating processes based on regulations and best practices. 6. Increased flexibility: Process-based business software applications can be configured (not customised) to meet the specific needs of an organisation, increasing flexibility and allowing businesses to adapt more easily to changing conditions.