Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries

Baird, R.; Bloomfield, Sally F.

• Part 1 Identifying the issues: control of microbial contamination in cosmetics, toiletries and non-sterile pharmaceuticals; hazards associated with the microbiological contamination of cosmetics, toiletries and pharmaceuticals. Part 2 Control in manufacture: microbiological control of raw materials; control of microbial contamination during manufacture. Part 3 Control through preservation: natural and physical preservative systems; the effect of container materials and multiple phase formulation components on the activity of antimicrobial agents; formulation aspects of the preservation of skin and hair products; preservation of solid oral dosage forms; development of preservative systems; microbial resistance to preservative systems; safety evaluation of preservatives. Part 4 Microbiological control - methods and standards: preservative efficacy testing of pharmaceuticals, cosmetics and toiletries and its limitations; challenge tests and their predictive ability; new methodology for microbial quality assurance; microbial contamination of manufactured products - official and unofficial limits.