Pharmaceutical products microbiological quality

For food and drink, medical, pharmaceuticals and cosmetics production the microbiological quality of the water becomes paramount. Even in applications where biological quality is not directly important, uncontrolled growth can be a damaging nuisance. Warm-water systems and cooling circuits in particular are a potential hazard (e.g. from Legionella). Some water treatment or conditioning is commonly required. 

Pharmaceutical microbiology may be defined as that part of microbiology which has a special bearing on pharmacy in all its aspects. This will range fiom the manufacture and quality control of pharmaceutical products to an understanding of the mode of action of antibiotics. The full extent of microbiology on the pharmaceutical area may be judged fiom the chapter contents. 

Regulatory expectations for microbial bioburden for nonsterile pharmaceutical products are reviewed using the FDA guide to inspections of microbiological quality control laboratories [2], purified water systems [27], topical products [28], and oral solutions and suspensions [29]. 

Microbiological quality control of pharmaceutical preparations and monitoring of production areas depend on the detection and quantification of micro-organisms. The classical, growth based, methods and some of the commercially available alternative methods are discussed. 

Understanding essential microbiological concepts is necessary in designing both microbiologically stable pharmaceutical products and ensuring an effective quality control and monitoring program within the... 

The second group consists of preservatives (see Sect 23.8), used to guarantee the microbiological quality of the product throughout its shelf life. For example esters of hydroxy-benzoic acid, quaternary ammonium substances and sorbic acid are widely used in pharmaceutical and cosmetic preparations. Other preservatives that are used include phenol, chlorhexidine, benzoic acid and benzyl alcohol. 

Pharmaceutical microbiology discusses aU aspects of microbiology in pharmaceutical production from the manufacture and quality control of pharmaceutical products through to an understanding of the mode of action of antibiotics. 

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