Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous...

Area of Science:

• Pharmaceutical Science
• Chemical Engineering
• Analytical Chemistry

Background:

• Quality by Design (QbD), Real-Time Release Testing (RTRT), and Continuous Process Verification (CPV) aim to enhance pharmaceutical product quality.
• These frameworks emphasize process controls and intermediate quality attributes (IQAs) over end-product testing for better quality assurance.
• Process Analytical Technology (PAT) emerged to analyze IQAs during manufacturing, aiding regulatory specifications and continuous improvement.

Purpose of the Study:

• To review recent advancements in pharmaceutical PAT tools and their applications in various unit operations.
• To identify significant IQAs monitored by PAT across different unit operations for control strategy development.
• To provide an overview of equipment, PAT tools, statistical methods, and preprocessing techniques used in pharmaceutical PAT.

Main Methods:

• Literature review of recent pharmaceutical PAT tools and their applications.
• Analysis of PAT applications based on pharmaceutical unit operations.
• Identification of key IQAs monitored by PAT for control strategies.

Main Results:

• Recent PAT tools have significantly advanced, enabling efficient and precise monitoring of IQAs in pharmaceutical manufacturing.
• Specific PAT tools and their applications are presented for various unit operations.
• The review details equipment, PAT tools, multivariate statistical methods, and preprocessing techniques relevant to pharmaceutical PAT.

Conclusions:

• PAT is a fundamental tool for current QbD and CPV frameworks.
• Advancements in PAT tools are crucial for improving drug product quality in the pharmaceutical industry.
• PAT facilitates enhanced control strategies for continuous manufacturing and real-time release testing.