Abstract

A REVIEW ON PROCESS ANALYTICAL TECHNOLOGY (PAT) IN FREEZE DRIED PHARMACEUTICAL PRODUCTS

P. Jhansi Rani, Sk. Haseena*, K. T. Sunil Kumar, Ch. Vennela, P. Sai Pravallika, T. Durga Satyavathi, M. Mohan Varma

ABSTRACT

Process analytical technology (PAT) has been defined as a mechanism to design, analyze and control pharmaceutical manufacturing processes through measurement of critical process parameters which affect critical quality attributes. PAT checks the quality of raw material attributes both physically and chemically (i.e. at off-line, on-line, in-line). The main goal of PAT is to provide successful tools such as multivariate data analysis and acquisition tools, modern process analyzers or analytical chemistry, endpoint process monitoring, controlling tools and continuous improvement and knowledge improvement tools. It is primarily an element of the “control strategy.” This review represents a comprehensive list of process monitoring devices that can be used to monitor critical process parameters, including an in-depth assessment of primary drying, secondary drying, and similar mechanisms, as well as their correlation for successful scale-up. PAT is widely used in the pharmaceutical and biotechnological industries to better process efficiency by gaining a better understanding of formulation parameters and process variables. PAT saves a huge amount of time and money required for the sampling and analysis of products. PAT would be described in the context of several modern instruments and tools used in the analysis, control, and design of the freeze-drying process.

Keywords: PAT, Freeze drying, primary drying, CQA, Online- monitoring techniques.