Abstract

THE RESEARCH ON NOVEL TECHNIQUE OF PROCESS SCALE UP

Shashank Tiwari* and Dr. S. P. Mahapatra

Abstract

The aim of researcher in this research work is only to, the old technique of process scale up is to minimise by creating novel technique of process scale up. The scale up is the process as define to increasing the batch size or increasing the output of volumes. The old process scales up technique have many steps. It has trial batches, exhibit batch for approval by regulatory authority and validation batches for compile data and stability measurement, the validation batch complete in three steps, batch-1, batch-2 and batch-3 or first three batches after the approval of regulatory authority is called validation batches. This technique is the part of process development laboratories in Indian pharmaceutical industries. It is the counter part of Research and Development department. After the technology transfer by R&D the next step is process scale up by process development laboratory for approval of regulatory authority, validation, stability measurement and also compile the best possible parameters for technology transfer to production department for preparation of marketed batch.

Keywords: Scale Up, Batch Size, Trials, Validation, Exhibit.