Quantitative Microbial Risk Assessment of Pharmaceutical Products.

Monitoring of microbiological quality in the pharmaceutical industry is an important criterion that is required to justify safe product release to the drug market. Good manufacturing practice and efficient control on bioburden level of product components are critical parameters that influence the microbiological cleanliness of medicinal products. However, because microbial dispersion through the samples follows Poisson distribution, the rate of detection of microbiologically defective samples lambda (λ) decreases when the number of defective units per batch decreases.

Recovery of Gram-Positive Cocci and Candida albicans from Peroxygen/Silver-Based Disinfectants.

Neutralization method evaluation is an important first step in a disinfectant validation study program. It is also crucial in assessment of the efficiency of microbial recovery media in the presence of a residual biocidal agent. In the present study, four commercially available peroxygen/silver-based disinfectant formulae--intended to be used in a pharmaceutical facility sanitization program--were tested at two dilutions against three Gram-positive cocci and one yeast; Staphylococcus aureus (ATCC 6538), Kucoria rhizophila (ATCC 9341) and Candida albicans (ATCC 10231) and Staphylococcus capitis as an environmental monitoring (EM) isolate sample (identified by miniaturized biochemical identification system).