Control of microbiological processes

Modem HPLC finds its abundant applications not only confined to isolation of natural pharmaceutically active compounds, control of microbiological processes but also assay of pure drugs and their dosage forms. A few typical examples will be discussed below ... 

Subpart B, Organization and Personnel 211.22 Responsibilities of the quality control unit 211.25 Personnel qualifications 211.113 Control of microbiological contamination Subpart F, Production and Process Controls Subpart I, Laboratory Controls 211.167 Special testing... 

According to 211.113 Control of microbiological contamination, pharmaceutical manufacturers need written procedures describing the systems designed to prevent objectionable microorganisms in both nonsterile and sterile drug products. All sterilization processes used to manufacture parenteral drugs need to be validated. 

Mitchell, Ralph, and Ji-Dong Gu, eds. Environmental Microbiology. 2d ed. Hoboken, N.J. Wiley-Black-well, 2010. This revision of one of the most successful books on environmental microbiology takes a comprehensive look at the role of microbiological processes related to environmental deterioration, with a focus on the detection and control of environmental contaminants. 

Industrial antimicrobial agents are chemicals used to prevent the adverse consequences of microbiological activity in processes and products. Some are unique to this segment and others are drawn from the antimicrobial agents used in medicine, agriculture, and sanitary appHcations. Industrial antimicrobials are selected where process or stricdy physical conditions, such as irradiation or heat, are impractical or ineffective in controlling microbiological activity. 

Uyttendaele, M., Neyts, K., Vanderswalmen, H., Notebaert, E. and Debevere, J. (2004) Control of Aeromonas on minimally processed vegetables by decontamination with lactic acid, chlorinated water, or thyme essential oil solution . International Journal of Food Microbiology, 90, 263-271. 

HPLC-controlled analysis of a microbiological process during Penicillin Production Chromatographic conditions are as follows ... 

In the case of recombinant proteins intended for use in sterile pharmaceutical products, additional process controls on microbiologic aspects of analysis must be established and validated to ensure aseptic conditions throughout the manufacturing process. 

Chapter 5, on Biochemical Engineering, has been completely rewritten in two sections by Dr R. L. Lovitt and Dr M. G. Jones with guidance from the previous author, Professor B. Atkinson. The earlier part deals with the nature of reaction processes controlled by micro-organisms and enzymes and is prefaced by background material on the relevant microbiology and biochemistry. In the latter part, the process engineering principles of biochemical reactors are discussed, and emphasis is given to those features which differentiate them from the chemical reactors described previously. 

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