Pharmaceutical Microbiology and Biotechnology

Biography

Biography: Muhammad Shahid Khan

Abstract

The validation of aseptic processing is carried out by media fill (also known as process simulation, simulated product fills, broth trials, broth fills etc). The media fill is a technique in which a liquid microbiological growth medium is prepared and filled in place of actual product in a simulation of normal manufacturing process. This process normally includes exposing the microbiological growth medium to product contact surfaces of equipment, container closure systems, critical environments, and process manipulations to closely simulate the same exposure that the product itself will undergo. The final containers are then incubated and checked for microbial growth. Results are then interpreted to assess the potential for a unit of drug product to become contaminated during actual operations (e.g., start-up, sterile ingredient additions, aseptic connections, filling, closing). The purpose of media fill study is to validate that the processes, systems, environment, container closure system, practices, equipment, personnel etc. are capable of producing a sterile product in a consistent and reproducible manner. The medium used should support the growth of a wide variety of microorganisms, including aerobic bacteria, yeasts and moulds (non-selective medium). Mostly Soybean Casein Digest Medium (SCD) also known as tryptone soya broth (TSB) is used.