Abstract
This work describes lyophilization process validation and consists of two parts. Part I focuses on the process design and is described in the current paper, while part II is devoted to process qualification and continued process verification. The intent of these articles is to provide readers with recent updates on lyophilization validation in the light of community-based combined opinion on the process and reflect the industrial prospective. In this paper, the design space approach for process design is described in details, and examples from practice are provided. The approach shows the relationship between the process inputs; it is based on first principles and gives a thorough scientific understanding of process and product. The lyophilization process modeling and scale-up are also presented showing the impact of facility, equipment, and vial heat transfer coefficient. The case studies demonstrating the effect of batch sizes, fill volume, and dose strength to show the importance of modeling as well as the effect of controlled nucleation on product resistance are discussed.Graphical abstract
Highlights
Pharmaceutical product stability can often be improved by removing water or other solvents in a controlled manner through the process referred to as lyophilization or freezedrying [1]
A lyophilization process is developed by trial and error methods where, for a given collapse temperature of a formulation, experiments are performed with various shelf temperature and chamber pressure values until the output parameters product temperature and product quality at the end of freezing and drying phases match with the target product temperature and product quality attributes
In part I, the process design approach relying on generating a design space for a given product and equipment combination is presented and illustrated with examples from practice
Summary
Pharmaceutical product stability can often be improved by removing water or other solvents in a controlled manner through the process referred to as lyophilization or freezedrying [1]. It is good practice to challenge the borders of the design space to determine the likelihood of product failure, choked flow of the equipment, and to examine the effect of the processing conditions on primary drying time.
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