Towards the drug factory microbiome: microbial community variations in an antibiotic-producing manufacturing plant (original) (raw)
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Microbiological Environmental Monitoring in Pharmaceutical Facility
Egyptian Academic Journal of Biological Sciences, G. Microbiology, 2011
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.
BMC Microbiology, 2018
Background: The presence of microrganisms in pharmaceutical production plant environments is typically monitored by cultural methods, however these cannot detect the unculturable fraction of the microbial community. To get more accurate information on the composition of these indoor microbial communities, both water and air microbiome from a pharmaceutical production plant were profiled by 16S amplicon sequencing. Results: In the water system, we found taxa which typically characterize surface freshwater, groundwater and oligotrophic environments. The airborne microbiome resulted dominated by taxa usually found in outdoor air in combination with human-associated taxa. The alpha-and beta-diversity values showed that the heat-based sanitization process of the water plant affects the composition of the water microbiome by transiently increasing both diversity and evenness. Taxonomic compositional shifts were also detected in response to sanitization, consisting in an increase of Firmicutes and α-Proteobacteria. On the other hand, seasonality seems to be the main driver of bacterial community composition in air of this work environment. Conclusions: This approach resulted useful to describe the taxonomy of these indoor microbiomes and could be further applied to other built environments, in which the knowledge of the microbiome composition is of relevance. In addition, this study could assist in the design of new guidelines to improve microbiological quality control in indoor work environments.
Biodiversity of microbiota in cephalosporin-manufacturing environments at T3A factory, Assiut, Egypt
The diversity of airborne bacteria and fungi inside and outside the T3A cephalosporin production factory was studied using different microbiological techniques. Results of indoor aeromicrobiota showed complete absence of microbial units in the environment of aseptic filling machine (class A). The counts of microbes in the aseptic filling room (class B) as well as in gowning room (class C) and in the rooms designed for preparation and filling of non-sterile cephalosporin capsules and dry mix (class D) were within the limits recommended by WHO guidelines. The count of outdoor airborne microbes using the air sampler technique was about 7-folds that of indoor air (6240 versus 854 colonies). The number of species isolated from the outdoor air was higher than that of indoor air (17 versus 10 species). Microbiological analysis of water showed much lower counts of microbes in purified water than in city water samples (80 versus 761 colonies). Microbes were also isolated from 60% of non-ster...
A Rapid and Nondestructive Method for Microbiological Testing in Pharmaceutical Manufacturing
2006
Improving the performance of pharmaceutical microbiological quality control (QC) testing is often included in the goals of the FDA’s Process Analytical Technology initiative. That a nineteenth century microbiologist would recognize the methods used by twenty-first century pharmaceutical manu facturers to detect and enumerate microbial contaminants, however, testifies to the glacial pace of technical change in microbiological QC. The persistence of the dominant detection technology, microbial culture, stems in large part from its numerous advantages. Culture tests use low-cost materials, minimize regulatory risk (they are the regulatory “gold standard”), demand low-level skills, deliver high sensitivity for culturable cells, yield pure cultures that can be used to identify contaminating microbes, and are useful for all of the key microbiological QC tests. But culture methods also bring some expensive drawbacks. Slow testing turnaround times (due to extensive cellular replication requ...
The Human Microbiome Project and Pharmaceutical Quality Control Microbiology
One of the more exciting contemporary research activities in human biology has been the Human Microbiome Project (HMP) (1). The insights derived from the HMP have revealed details about the relationship between humans and the microorganisms we live with, and could not live without. In 2013, the first publications appeared that attempted to put the HMP reports into a pharmaceutical microbiology context (2). The purpose of this communication is to consider the HMP in the context of other recent insights into microbiological control and to explore how this knowledge could (or should) change the way standards are set for healthcare products. Microbiological analysis will also be explored with due consideration of what has been learned since the standards have evolved.
Characterizing the Microbiota of a Pharmaceutical Water System-A Metadata Study
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Foodborne Pathogens and Disease
Microbial safety is critically important for powdered infant formula (PIF) fed to neonates, with underdeveloped immune systems. The quality and safety of food products are dictated by those microorganisms found in both raw materials and the built production environment. In this study, a 2-year monitoring program of a production environment was carried out in two PIF factories located in the Republic of Ireland, and the environmental microbiome in different care areas of these sites was studied by using a 16S ribosomal RNA (rRNA)-based sequencing technique. Results highlighted a core microbiome associated with the PIF factory environment containing 24 bacterial genera representing five phyla, with Acinetobacter and Pseudomonas as the predominant genera. In different care areas of the PIF factory, as hygiene standards increased, deciphered changes in microbial community compositions became smaller over time and approached stability, and bacteria dominating the care area became less influenced by the external environment and more by human interactions and raw materials. These observations indicated that the microbial composition can be altered in response to environmental interventions. Genera Cronobacter and Salmonella were observed in trace amounts in the PIF factory environment, and bacterial genera known to be persistent in a stressed environment, such as Acinetobacter, Bacillus, Streptococcus, and Clostridium, were likely to have higher abundances in dry environment-based care areas. To our knowledge, this is the first study to characterize the PIF production environment microbiome using 16S rRNA-based sequencing. This study described the composition and changing trends of the environmental microbial communities in different care areas of the PIF manufacturing facility, and it provided valuable information to support the safer production of PIF in the future.
2018
In general, environment of the pharmaceutical company consists of water, air and surfaces, which are often contaminated with microorganisms introduced from humans and environment. These germs represent microbial reservoirs that may pose a risk of product contamination. In the current study, we determined the microbiological quality of the surfaces in a selected inanimate surfaces in a pharmaceutical parenteral (sterile injections) manufacturing company, Chennai, in order to prevent microbial contaminations. A total of 231 samples were collected in the study over a period of one year. The samples were collected from seven different surfaces. An overall microbial identification showed the presence of 11 species which were alienated into gram positive (6 species) or gram negative (2 species) bacteria, fungi (2 species) and yeast (1 species) respectively. The current study results confirmed the need to implement systematic measures in pharmaceutical company surveillance to be adapted as...
Pharmaceutical Microbiology: Current and Future Challenges
It is difficult to define when the term " pharmaceutical microbiologist " emerged from the collective shadows of industrial and clinical microbiology. Various decades can lay claim to the use of the term, but it was not until the 1990s that the term became properly articulated. This was following the formation of two professional groups – the Pharmaceutical Microbiology Forum in the U.S. (for which the late Scott Sutton was instrumental in its development) and the Pharmaceutical Microbiology Interest Group (Pharmig), both of which came into being around 1991. Since these pivotal moments, the range of activities associated with pharmaceutical microbiology has extended from the laboratory and into the production environment. Today " s pharmaceutical microbiologist needs to have an understanding of engineering, regulation, the R&D process, and production workflows. The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes, cleanrooms, and how to effectively evaluate microbial risks to products from people and processes. To meet regulatory expectations, the role of the microbiologist is essential. To add to this, the input from quality assurance personnel, engineers, and process specialists is required. Whilst there is a continuing need for monitoring of the environment and conducting standardized laboratory tests, industrial pharmaceutical microbiology has moved a great deal in the past decade to embrace microbiological audits; rapid microbiological methods; conducting risk assessments, both proactive in terms of minimizing contamination and reactive, in terms of addressing microbial data deviations; and also ensuring that processes meet " quality by design " principles.
Presence of Antibiotic Resistant Bacteria along the Pharmaceuticals Production Line
Procedia Engineering, 2013
The antimicrobial susceptibility of forty-five bacterial isolates obtained from different pharmaceutical raw materials of several companies in Cairo, Egypt during June to august, 2008 was determined using agar diffusion method. Only fourteen out of forty-five antibiotic resistant bacterial isolates were selected according to their sensitivity to equal or more than two antibiotics used. Isolates were subjected to antimicrobial susceptibility testing. The percent of resistance to seven antibiotics were Colis. (16.7%), Azithr. (78.6%), Oxytet. (0.0%), Amox. (21.4%), Kan. (42.8%), Cipro. (0.0%), and Spictin. (100.0%). Active potency of the raw materials was determined by incubating the drugs with and without microbes using HPLC and UV spectrophotometer. Among 14 selected isolates two were found to contain plasmids that are probably related to their drug resistance.