Welcome to the second part of our series, 'The ATMP Manufacturer's Guide to Commercialisation and cGMP Compliance.' In this article, we will explore the power of the automation pyramid in scaling ATMP manufacturing while ensuring efficiency and compliance. By leveraging automation, ATMP manufacturers can achieve faster scalability, maintain regulatory compliance, and optimize product quality. Let's dive into the details of how automation can revolutionize the ATMP manufacturing process.
Defining the Automation Pyramid
Understand the concept and importance of the automation pyramid in ATMP manufacturing.
The automation pyramid serves as a roadmap for ATMP manufacturers to achieve scalability, compliance, and flexibility in their manufacturing processes. It consists of different levels, from sensors and actuators to enterprise resource planning (ERP) systems.
At the base of the pyramid are the operational technology levels, which enable measurements and control of manufacturing processes. These levels help eliminate manual steps, reduce human error, and improve operational efficiency.
As we move up the pyramid, we reach the information technology levels, such as manufacturing execution systems (MES) and enterprise resource planning (ERP) systems. These levels provide real-time data insights, traceability, and streamlined process control.
By implementing the automation pyramid, ATMP manufacturers can achieve continuous compliance, optimise manufacturing processes, and ensure product quality and reproducibility.
Key Benefits for ATMP Manufacturers
Discover the advantages of implementing automation in ATMP manufacturing.
The automation pyramid offers several key benefits for ATMP manufacturers:
Compliance:
By incorporating FDA 21 CFR Part 11 and EU GMP Annex 11 regulations at the beginning of the automation pyramid, ATMP manufacturers can ensure data integrity and compliance with regulatory standards.
Continuous Optimization:
ATMP manufacturers can leverage automation and advanced technologies like artificial intelligence (AI) and machine learning (ML) to optimize processes, improve product quality, and proactively monitor manufacturing data.
Modularity and Scalability:
Automation enables ATMP manufacturers to quickly adapt to changes in product pipelines and scale up production as needed. It offers flexibility and modularity in manufacturing processes.
By embracing automation, ATMP manufacturers can reduce regulatory risks, improve process efficiency, and ensure the consistent delivery of high-quality therapies to patients.
The Hierarchy of the Automation Pyramid
Explore the different levels of the automation pyramid and their roles in ATMP manufacturing.
The automation pyramid is divided into five levels, each serving a specific purpose in ATMP manufacturing:
Operational Technology Levels:
- Level 0: Sensors and Actuators
- Level 1: Automation
- Level 2: Monitoring, Control, and Data Acquisition (SCADA)
Transfer Level:
- Level 3: Manufacturing Execution System (MES)
Information Technology Level:
- Level 4: Enterprise Resource Planning (ERP)
Each level of the automation pyramid plays a crucial role in data collection, process control, and business operations, ultimately enabling ATMP manufacturers to achieve efficiency and scalability.
Process Automation within the Pyramid's Foundation
Learn how process automation in the base of the automation pyramid benefits ATMP manufacturers.
Process automation at the foundation of the automation pyramid offers significant advantages for ATMP manufacturers:
Reduced Regulatory Risk:
By implementing automated technologies, ATMP manufacturers can reduce regulatory risks through process closure and adherence to compliance standards.
Real-time Monitoring and Quality Control:
Automation enables the monitoring of critical quality attributes (CQAs) and critical process parameters (CPPs) in real-time. This allows for quick detection of deviations and adjustments, resulting in lower costs and improved product quality.
Standardization and Flexibility:
Automation and standardization of processes reduce costs associated with programming and validation efforts when switching between different products or batches. It also offers greater flexibility for adjustments and modifications.
Process automation within the automation pyramid's foundation empowers ATMP manufacturers to achieve regulatory compliance, improve quality control, and adapt to changing manufacturing requirements.
Impacts on Manufacturing at the Top of the Pyramid
Understand the implications of automation at the top levels of the automation pyramid in ATMP manufacturing.
The top levels of the automation pyramid have significant impacts on ATMP manufacturing:
Traceability and Quality Control:
Automation enables the tracking and tracing of individual ATMP processing steps, ensuring proper cooling, and maintaining quality control measures throughout the manufacturing process.
Continuous Regulatory Compliance:
Manufacturing data is crucial for regulatory compliance. Automation ensures that data is up-to-date, logged, and easily accessible, facilitating compliance with cGMP standards.
Streamlined Process Control:
Automation allows for in-process control (IPC) tests to ensure consistency and quality. It helps identify bottlenecks and streamline the manufacturing process for improved efficiency.
Insightful Data Analytics:
Automated capture and harmonization of data enable data scientists to analyze and create insightful models, improving decision-making and process optimization.
By embracing automation at the top levels of the automation pyramid, ATMP manufacturers can enhance traceability, ensure compliance, and gain valuable insights for process improvement.
