Abstract

PROCESS VALIDATION OF LYOPHILIZATION PROCESS A REVIEW

Aditya Mishra*, Dr. T. R. Saini and Dr. V. K. Maurya

ABSTRACT

Lyophilization mainly considered as one of best method to promote the long-term stability of many pharmaceutical drug product. Lyophilization, more generally known as “freeze-drying,” is a means of dehydration process (a process that remove water molecules/ desiccation) used in the foods like meat industries, many chemicals industries, pharmaceutical, and biotechnology industries. In each of cases, lyophilization is used to promote the long term stability of a decomposable product and /or making the product easier to transport or/ and store in different words the degradative or less stable in an aqueous medium of these systems forms a real barrier against the clinical use of many pharmaceuticals. In the biotechnology industry and most other pharmaceutical industries, lyophilization /freeze drying is used as a last processing step for purified active pharmaceutical ingredients (APIs) or/ and drug formulation to stabilize the protein and other pharmaceuticals for long-term storage. This article reviews the state of the art of lyophilization and process validation considerations of freeze dried product with parameter of PAT and QbD tools in each stage. This review discusses about the most important parameters that promote the success of lyophilization of these frangible systems, and gives an overview of freeze-drying process and formulation strategies which is focused on the impact of formulation and process on particle stability point of view.

Keywords: Process validation, Lyophilization, QbD, Primary Drying, Secondary Drying, Freezing, Quality, Sublimation, PAT, Freeze- Drying.