This compendium lists drugs in alphabetical order, with each discussed under fetal risk and breast-feeding summaries. A list of recent references is included. Since the previous edition, published in 1990, more than 100 new drugs have been added. The authors have included animal studies, but they correctly point out that, although such studies may be predictive for the human, the accuracy depends on the species used and other factors. Much of the original information was derived from the collaborative Perinatal Project published in Birth Defects and Drugs in Pregnancy in 1977 and has been the "gold standard" for teratologists. This edition includes, however, data from a more recent and larger surveillance that covers more than 229 000 completed pregnancies over a 7-year period (1985 through 1992) from the Epidemiology and Surveillance Center for Drugs and Biologicals of the US Food and Drug Administration. The authors established a risk factor for

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk

ホルミジウムとアナベノプシスの生産する高分子凝集物質の性質(Applied and Environmental Microbiology,53,1987)

Isolation and biochemical characterization of heavy-metal resistant bacteria from tannery effluent in Chittagong city, Bangladesh: Bioremediation viewpoint

https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1347&context=schfsehart

Improving microbiological safety and quality characteristics of wheat and barley by high voltage atmospheric cold plasma closed processing.

SUMMARY Burkholderia cepacia (formerly Pseudomonas cepacia) was once thought to be a single bacterial species but has expanded to the Burkholderia cepacia complex (Bcc), comprising 24 closely related opportunistic pathogenic species. These bacteria have a widespread environmental distribution, an extraordinary metabolic versatility, a complex genome with three chromosomes, and a high capacity for rapid mutation and adaptation. Additionally, they present an inherent resistance to antibiotics and antiseptics, as well as the abilities to survive under nutrient-limited conditions and to metabolize the organic matter present in oligotrophic aquatic environments, even using certain antimicrobials as carbon sources. These traits constitute the reason that Bcc bacteria are considered feared contaminants of aqueous pharmaceutical and personal care products and the frequent reason behind nonsterile product recalls. Contamination with Bcc has caused numerous nosocomial outbreaks in health care facilities, presenting a health threat, particularly for patients with cystic fibrosis and chronic granulomatous disease and for immunocompromised individuals. This review addresses the role of Bcc bacteria as a potential public health problem, the mechanisms behind their success as contaminants of pharmaceutical products, particularly in the presence of biocides, the difficulties encountered in their detection, and the preventive measures applied during manufacturing processes to control contamination with these objectionable microorganisms. A summary of Bcc-related outbreaks in different clinical settings, due to contamination of diverse types of pharmaceutical products, is provided.

Burkholderia cepacia Complex Bacteria: a Feared Contamination Risk in Water-Based Pharmaceutical Products.

Regular environmental monitoring samples for microbiological quality of different locations in pharmaceutical facility are by far very critical measure in controlling clean area and environment which have direct impact on the microbiological quality of the final pharmaceutical products. Different methods were used to collect samples from different locations. These samples were processed and followed by isolation and identification. The obtained data were analyzed to find microbial distribution in the environment of pharmaceutical facility. Twenty one bacterial and fungal species were isolated from different locations in the pharmaceutical facility. Group of genus Staphylococci contributes to 38.4% of total positive samples while genus Micrococci contributes to 22.4% and Gemella morbillorum represents 1.1%. Genus Bacilli represents 35.0%, Candida albicans 1.3%, Klebsiella pneumonia 1.0% and Stenotrophomonas maltophilia 0.01%. Most microorganisms found among 7 identified genuses were belonging to Staphylococcus, Micrococcus and Bacillus species.

http://microbiology.eajbs.eg.net/pdf/vol3.n1/9.pdf

Microbiological Environmental Monitoring in Pharmaceutical Facility

The microbiological quality of water for human consumption is a critical safety aspect that should not be overlooked, especially when considering facilities for healthcare and the treatment of ill populations. Thus, the biological stability of water is crucial for the distribution network that delivers potable water to the final users for consumption and other human activities. The present work aimed to study a municipal distribution network system for city water within a healthcare facility. The implementation of the statistical analysis was conducted over long-term data collection, and the comparative study for the microbiological count of the water samples - from different points-of-use was assessed using the non-parametric analysis of the Kruskal-Wallis test. The comparative study involved a preliminary general one-way Analysis of Variance (ANOVA) followed by ad-hoc pairwise comparison. The statistical study involved a correlation matrix and a dendrogram to elucidate the level of association between different sections in the network. The ports C4 and C13 were at the trough in the microbiological count, in contrast to C13, which showed the highest level of the average microbial density. Despite a low to moderate level of correlation between the datasets of the water network, the tree diagram (dendrogram) analysis showed remarkable clustering. Use points could be grouped into three dense groups based on abrupt cuts in the similarity value. The study was useful in the analysis of the pattern and behavior of the microbial quality in a distribution water network in a specific area of the study. This work in turn would help in investigating the areas of improvement and defect spotting, in addition to assessing the biological stability of the water distribution system. The study could be extended to cover other different processed water networks, such as distilled, deionized, and purified water, as well as Water-For-Injection (WFI). Doi: 10.28991/HIJ-2022-03-01-03 Full Text: PDF

/pdf/dendrogram-analysis-and-statistical-examination-for-total-hrx4djv6.pdf

Dendrogram Analysis and Statistical Examination for Total Microbiological Mesophilic Aerobic Count of Municipal Water Distribution Network System

Distribution of bacterial contamination in non-sterile pharmaceutical materials and assessment of its risk to the health of the final consumers quantitatively

Bacterial vs. fungal spore resistance to peroxygen biocide on inanimate surfaces

The performance of water treatment plant for production of purified water is critical aspect in drug pharmaceutical manufacturing especially for semisolid and liquid products; where water represents the major bulk component. The water station investigated; herein, thermally and chemically sanitize city waterand is primarily made out of three major compartments: pretreatment unit, Reverse Osmosis-Electrodeinonizer (RO-EDI) compartment and distribution system. In order to assess the quality of different water treatment steps, water samples were taken from each processing stage in the water station and analyzed microbiologically using standard procedure. Conductivity and total organic carbon (TOC) measurements were assessed in samples of the final output waterat two points viz: after the tank of purified waterand at the return point of the distribution loop. Monitoring was conducted along a two years period of data gathering and was transformed logarithmically to approximate normality. Results were interpreted and analyzed using statistical software package and Six Sigma tools to identify the area of risk, processes that need improvement and control chart structuring for each stage. RO-EDI phase wasfound to be the most critical part, showing the greatest impact on the total performance of water station and need improvement. This partition contributed to 87% of the total defect based onCumulative Pareto with rolled throughput yield (RTY) of 0.88. RO-EDI is sensitive to microbial burden and needs continuous monitoring and preventive measures especially during maintenance and shutdown intervals by using proper thermal sanitization at relatively higher rate than the other compartments.

Assessment of Purified Water Quality in Pharmaceutical Facility Using Six Sigma Tools

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