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Microbial pharmaceutical quality

Mariana Nunes de Menezes, Bianca Aparecida de Marco, Flávia Angélica Masquio Fiorentino, Alexander Zimmermann, Ana Carolina Kogawa, Hérida Regina Nunes Salgado
Bacterial resistance is a growing and worrying factor. The high reproducibility of these resistant microorganisms tends to influence the development of new drugs and research related to product quality control. Among the existing antimicrobials, flucloxacillin (FLU) was designed for oral and injectable administration with bactericidal activity. FLU sodium is the form used in pharmaceutical formulations. It is an antimicrobial resistant against penicillinase, an enzyme responsible for cleaving the beta-lactam ring of penicilins, which leads to inactivity of the drug...
May 30, 2018: Critical Reviews in Analytical Chemistry
Rebecca H Weissinger, Brett R Blackwell, Kristen Keteles, William A Battaglin, Paul M Bradley
Pharmaceuticals and personal care products (PPCPs), wastewater indicators (WWIs), and pesticides (herein, Contaminants of Emerging Concern [CECs]) have been documented in surface waters throughout the world and have associated risks to aquatic life. While much research has focused on temperate and urbanized watersheds, less is known about CEC presence in semi-arid landscapes, where water availability is limited and populations are low. CEC presence in water and sediment is reported for 21 sites in eight U.S...
May 2, 2018: Science of the Total Environment
Victoria Rutter, Amy Hai Yan Chan, Chloe Tuck, Lina Bader, Zaheer-Ud-Din Babar, Ian Bates
The biennial Commonwealth Heads of Government Meeting (CHOGM) this year is based around four key themes: prosperity, fairness, sustainability and security. This is an opportune time to consider the role of pharmacists in healthcare delivery, and particularly their contribution to achieving the United Nations Sustainable Development Goals (SDGs). As a member of the Commonwealth Health Professions Alliance (CHPA), the Commonwealth Pharmacists Association (CPA) has been working to ensure that pharmacy-related aspects of health are represented in the advocacy papers submitted by Civil Society...
2018: Journal of Pharmaceutical Policy and Practice
Muhammad Sohail, Mudassir, Muhammad Usman Minhas, Shahzeb Khan, Zahid Hussain, Marcel de Matas, Syed Ahmed Shah, Samiullah Khan, Mubeen Kousar, Kaleem Ullah
Ulcerative colitis (UC) is an inflammatory disease of the colon that severely affects the quality of life of patients and usually responds well to anti-inflammatory agents for symptomatic relief; however, many patients need colectomy, a surgical procedure to remove whole or part of the colon. Though various types of pharmacological agents have been employed for the management of UC, the lack of effectiveness is usually predisposed to various reasons including lack of target-specific delivery of drugs and insufficient drug accumulation at the target site...
April 2, 2018: Drug Delivery and Translational Research
Ana M C Santos, Mara S Doria, Luís Meirinhos-Soares, António J Almeida, José C Menezes
Microbial quality control of non-sterile drug products has been a concern to regulatory agencies and the pharmaceutical industry since the 1960s. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted if such events occur. To better manage risk and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in non-sterile drug products manufacturing, be able to evaluate their potential impact on final product quality, and apply mitigation actions...
January 2018: PDA Journal of Pharmaceutical Science and Technology
María Jesús Andrés-Costa, Kathryn Proctor, Marco T Sabatini, Anthony P Gee, Simon E Lewis, Yolanda Pico, Barbara Kasprzyk-Hordern
European legislation focusing on water quality is expected to broaden to encompass several pharmaceuticals as priority hazardous substances. This manuscript aims to challenge current regulatory approaches that do not recognize stereochemistry of chiral pharmaceuticals by testing the hypothesis that environmental transformation and effects of chiral pharmaceuticals are stereoselective. Our experiments revealed that, while degradation of chiral fluoxetine (FL) in river water occurs via non-enantioselective photochemical and mildly-enantioselective microbial processes favoring the (R)-enantiomer, a pronounced enantioselectivity favoring (S)-FL (leading to the formation of (S)-NFL (norfluoxetine)) is observed during activated sludge treatment...
November 17, 2017: Scientific Reports
Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner, Tina Choe
A real-time polymerase chain reaction (RT-PCR) assay was developed to detect Burkholderia cepacia in pharmaceutical products contaminated with low levels of bacteria. Different pharmaceutical suspensions were artificially contaminated with B. cepacia , Escherichia coli , Staphylococcus aureus , and Bacillus megaterium After a 24 h incubation in trypticase soy broth with Tween 20, samples were streaked on mannitol salt, phenyl ethyl alcohol, eosin methylene blue, MacConkey, and pseudomonas isolation agar. Microbial DNA was extracted from each sample by using a Tris-EDTA, proteinase K, Tween 20 buffer...
January 2018: PDA Journal of Pharmaceutical Science and Technology
Lisa Paruch, Adam M Paruch, Anne-Grete Buseth Blankenberg, Ketil Haarstad, Trond Mæhlum
This study describes the first Norwegian microbial source tracking (MST) approach for water quality control and pollution removal from catchment run-off in a nature-based treatment system (NBTS) with a constructed wetland. The applied MST tools combined microbial analyses and molecular tests to detect and define the source(s) and dominant origin(s) of faecal water contamination. Faecal indicator bacteria Escherichia coli and host-specific Bacteroidales 16 s rRNA gene markers have been employed. The study revealed that the newly developed contribution profiling of faecal origin derived from the Bacteroidales DNA could quantitatively distinguish between human and non-human pollution origins...
September 2017: Water Science and Technology: a Journal of the International Association on Water Pollution Research
Amal M Hamdy, Moamen El-Massry, Mona T Kashef, Magdy A Amin, Ramy K Aziz
Microbiome projects are currently booming around the globe, enabled by advances in culture-independent microbial community analysis and high-throughput sequencing. One emerging application of microbiome science involves exploring microbial diversity in built environments, and one unexplored built environment is the pharmaceutical factory, notably factories producing antibiotics, as they could be enriched in antibiotic-resistant microbes. To examine the drug factory microbiome, we launched this interdisciplinary hypothesis-generating study to benchmark culture-independent microbiome analysis in drug manufacturing units producing antibiotics and nonantibiotic drugs, against traditional microbial identification and quantification techniques...
February 2018: Omics: a Journal of Integrative Biology
Javad Parvizi, Sue Barnes, Noam Shohat, Charles E Edmiston
In the modern operating room (OR), traditional surgical mask, frequent air exchanges, and architectural barriers are viewed as effective in reducing airborne microbial populations. Intraoperative sampling of airborne particulates is rarely performed in the OR because of technical difficulties associated with sampling methodologies and a common belief that airborne contamination is infrequently associated with surgical site infections (SSIs). Recent studies suggest that viable airborne particulates are readily disseminated throughout the OR, placing patients at risk for postoperative SSI...
August 14, 2017: American Journal of Infection Control
Mo Jiang, Kristen A Severson, John Christopher Love, Helena Madden, Patrick Swann, Li Zang, Richard D Braatz
Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products...
November 2017: Biotechnology and Bioengineering
Haniye Tolouie, Mohammad Amin Mohammadifar, Hamid Ghomi, Maryam Hashemi
Plasma processing has been getting a lot of attention in recent applications as a novel, eco-friendly, and highly efficient approach. Cold plasma has mostly been used to reduce microbial counts in foodstuff and biological materials, as well as in different levels of packaging, particularly in cases where there is thermal sensitivity. As it is a very recent application, the impact of cold plasma treatment has been studied on the protein structures of food and pharmaceutical systems, as well as in the packaging industry...
June 14, 2017: Critical Reviews in Food Science and Nutrition
Audrey Magron, Jonathan Laugier, Patrick Provost, Eric Boilard
The transfusion of platelets is essential for diverse pathological conditions associated with thrombocytopenia or platelet disorders. To maintain optimal platelet quality and functions, platelets are stored as platelet concentrates (PCs) at room temperature under continuous agitation-conditions that are permissive for microbial proliferation. In order to reduce these contaminants, pathogen reduction technologies (PRTs) were developed by the pharmaceutical industry and subsequently implemented by blood banks...
January 2018: Platelets
Mirco Bundschuh, Torsten Hahn, Mark O Gessner, Ralf Schulz
Pharmaceuticals contribute greatly to human and animal health. Given their specific biological targets, pharmaceuticals pose a significant environmental risk by affecting organisms and ecosystem processes, including leaf-litter decomposition. Although litter decomposition is a central process in forest streams, the consequences of exposure to pharmaceuticals remain poorly known. The present study assessed the impact of antibiotics as an important class of pharmaceuticals on the growth of the leaf-shredding amphipod Gammarus fossarum over 24 days...
May 2017: Ecotoxicology
Angela L Batt, Edward T Furlong, Heath E Mash, Susan T Glassmeyer, Dana W Kolpin
A national-scale survey of 247 contaminants of emerging concern (CECs), including organic and inorganic chemical compounds, and microbial contaminants, was conducted in source and treated drinking water samples from 25 treatment plants across the United States. Multiple methods were used to determine these CECs, including six analytical methods to measure 174 pharmaceuticals, personal care products, and pesticides. A three-component quality assurance/quality control (QA/QC) program was designed for the subset of 174 CECs which allowed us to assess and compare performances of the methods used...
February 1, 2017: Science of the Total Environment
K Kleinschmidt, E Wilkens, S P Glaeser, P Kaempfer, A Staerk, D Roesti
AIMS: The aim of this study was to develop and evaluate a real-time PCR technology for microbiological control methods to examine individualized cell therapeutics, an emerging class of pharmaceutical formulations. METHODS AND RESULTS: Oligonucleotide primers and hybridization probe for bacterial detection targeting the 16SrRNA gene were adapted based on Nadkarni et al. [Microbiology148 (2002) 257]. For detection of yeast and moulds, primers and probe were designed from conserved sequences of the 18SrRNA gene in this study...
April 2017: Journal of Applied Microbiology
Hideharu Shintani
 Water for injection (WFI) and purified water are the most widely used and stringently regulated raw material in pharmaceutical manufacturing. WFI is utilized for a parenteral drug product. Water system is monitored at frequent and routine frequency for demonstrating the overall system control and stability of performance. The critical ports demonstrating systemic control should be monitored more frequently. For reducing the overall risk of microbial contamination or microbial build-up, it is important to develop appropriate alert and action levels...
2016: Biocontrol Science
Mostafa Essam Eissa
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...
May 2017: PDA Journal of Pharmaceutical Science and Technology
Laura M Coughlan, Paul D Cotter, Colin Hill, Avelino Alvarez-Ordóñez
Biofilms are microbial communities characterized by their adhesion to solid surfaces and the production of a matrix of exopolymeric substances, consisting of polysaccharides, proteins, DNA and lipids, which surround the microorganisms lending structural integrity and a unique biochemical profile to the biofilm. Biofilm formation enhances the ability of the producer/s to persist in a given environment. Pathogenic and spoilage bacterial species capable of forming biofilms are a significant problem for the healthcare and food industries, as their biofilm-forming ability protects them from common cleaning processes and allows them to remain in the environment post-sanitation...
2016: Frontiers in Microbiology
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
The assurance of sterility of a parenteral drug product, prior to any human use, is a regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must demonstrate absence of microbial contamination through leaks as part of the container closure system (CCS) qualification, during manufacturing, for quality control purposes and to ensure microbiological integrity (sterility) during storage and shipment up to the end of product shelf life. Current regulatory guidances, which differ between countries and regions, provide limited detail on how to assess CCI...
March 2017: PDA Journal of Pharmaceutical Science and Technology
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