Current and future requirements to industrial analytical infrastructure-part 1: process analytical laboratories

Area of Science:

• Chemical Engineering
• Pharmaceutical Science
• Analytical Chemistry

Background:

• Global competitiveness in the chemical and pharmaceutical sectors relies on product quality and optimized resource utilization.
• Effective process control through reliable chemical process analytics is crucial for maintaining this competitiveness.
• Current Process Analytical Technology (PAT) requires enhanced flexibility and intelligence for seamless integration across the product lifecycle.

Purpose of the Study:

• To present a future vision for Process Analytical Technology (PAT), focusing on smart laboratories (Part 1) and smart sensors (Part 2).
• To explore the transferability of PAT methods from process development to operational production environments.
• To define requirements for the future role of laboratories in advancing PAT implementation.

Main Methods:

• Review of current PAT practices and limitations in laboratory and production settings.
• Conceptualization of digitalization-based knowledge management to bridge product development and PAT integration.
• Analysis of the desired transferability of analytical methods from development to scale-up and production.

Main Results:

• The study outlines the necessity for more flexible and intelligent PAT systems.
• Digitalization and knowledge management are identified as key enablers for accelerating PAT integration.
• A bidirectional knowledge flow between product development and production processes is proposed.

Conclusions:

• Future PAT must be smarter, leveraging digital tools for enhanced flexibility and knowledge management.
• Establishing PAT methods during process development is essential for successful transfer to production.
• This contribution (Part 1) defines laboratory requirements, paving the way for smart sensor functionalities in Part 2.