Abstract

CRITICALITY OF VACCUM IN LYPHOLISATION-1

Natrajan Iyer*, Aditya Prakash Sharma, Namit Kumar, Anmol Kumar, Rekha Mehta,

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Abstract

Lyophilization process is used in many different fields in pharmaceutical it is used for preserving thermolabile material. Lyophilization success depends upon refrigeration system hydraulic system and vacuum system. Vacuum plays major role in successful lyophilization. this article describes criticality of vacuum in Lyophilization process. Lyophilization processes are widely employed in the industrial field to preserve several kinds of substances, such as foods and drugs. In some cases, e.g., during the process optimization, the real-time measurement of mass and temperature is important to monitor drying rate and to prevent product damages because of unsuitable temperatures. In these cases, sensors and measurement instruments have to be installed inside the vacuum chamber of the freeze dryer, where temperature and pressure can reach -600C and 1 Pa respectively. This paper deals with the problems related to the measurement of mass and temperature inside freeze dryers and describes a measurement system that has been specifically designed to monitor lyophilization processes. Lyophilization is the common, but cost-intensive process. Freezing is an equally important step in Lyophilization, as it affects both process efficiency and quality of the product. However simple concept, freezing is probably the most complex step in lyophilization. Therefore, to get a more comprehensive understanding, the lyophilization methods and application are first summarized. The different techniques or method that can be used in lyophilization are also reviewed.

Keywords: Theory of Lyophilization, lyophilization Principle, The lyophilization process steps, Excipient in lyophilization, critically of vacuum in lyophilization.