Abstract

A COMPARATIVE STUDY ON THE ROUTINE STERILITY MONITORING AND THE PROCESS SIMULATION

Deepak Tripathi*, Ravinder Mohanty, Hemant Bhardwaj, Jatin Jaiswal

ABSTRACT

To evaluate the comparative study of aseptic process during routine monitoring and media fill. There are some parameter that was not performed in the routine practice during the production of sterile product but these parameter consider as a worst case during the media fill. In media fill we evaluate the routine practice of the production by the aseptic processing of injection formulation and filling activities through process simulation by substituting the product with a suitable growth medium. After process simulation we incubated all the filled vials and inspected all vials by the microbiologist. If any vial are showing the turbidity it will be a part of investigation and may be revalidated all the facility as per investigation.

Keywords: Mediafill, Sterile product, SCDA (Soyabean casein digest agar).