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Microbiological Concerns in Non-Sterile Manufacturing
Published in Jeanne Moldenhauer, Disinfection and Decontamination, 2018
Microbial contaminants can have diverse origins. The paradigm that Grade A/ISO 5 clean rooms are “sterile” contributes to the assumption that some significant error had to occur to result in a contaminated product. The several definitions of sterile add to the confusion and misunderstandings. The scientific definition of sterile is “without life”. Processed foods use the term “commercial sterility” which loosely means that the product does not contain potentially harmful microorganisms. For aseptically filled or terminally sterilized pharmaceutical products, sterile refers to the likelihood of a contaminated single unit. A sterility test can have different meanings based on the culture or regulations. For example, in the United States, a sterility test is a specified procedure used to detect the absence of specific types of microorganisms in a volume of product. In other countries, a sterility test may also simply mean the determination of microbial content.
Nanofibers: General Aspects and Applications
Published in Raj K. Keservani, Anil K. Sharma, Rajesh K. Kesharwani, Drug Delivery Approaches and Nanosystems, 2017
Raghavendra Ramalingam, Kantha Deivi Arunachalam
Sterility is the state of being free from pathogenic microorganisms. Ultraviolet radiation (UVR), antimicrobial solutions (AMS), ethanol, gamma radiation have been successfully used for sterilization of nanofibers. However, these techniques affect the physicochemical properties of prepared formulations. The sterilization techniques caused changes in the nanofiber morphology, dimensions, and a greater reduction in polymeric molecular weight, respectively. Among these sterilization techniques, AMS sterilized nanofibers showed superior cellular adhesion (Garg et al., 2014).
Microbiology of Sterilization Processes
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
The goal of this chapter is to give a general understanding of pharmaceutical microbiology, its role in the industry, and its impact on the quality of the finished products. Sterility is defined by the total absence of microorganisms. This is a simple concept but difficult to establish in absolute terms. It is often expressed in terms of the Probability of < 10−6 of a Nonsterile Unit (PNSU), i.e., less than or equal to one chance in one million that viable bioburden microorganisms are present.
Antibacterial properties of cotton fabric coated with cellulose nanofibers conjugated with pomegranate nanoparticles
Published in The Journal of The Textile Institute, 2023
Laryssa Pinheiro Costa Silva, Natane Aparecida de Oliveira, Rafaela Spessemille Valotto, Flávio Cunha Monteiro, Luis Alberto Contreras Alvarez, Letícia Miranda Cesário, Tadeu Ériton Caliman Zanardo, Ricardo Shuenk, Jairo Pinto de Olveira, Marco Cesar Cunegundes Guimarães
In this study we used two Gram-positive [Staphylococcus aureus (ATCC 29213) and Enterococcus faecalis (ATCC 29212)] and one Gram-negative [Escherichia coli (ATCC 25922)] bacteria strains. To ensure the sterility of the test, cotton fabric samples were previously autoclaved (121 °C/40 min) and the CNF + AuNPPomegranate complex was subjected to UV radiation for 15 min. The antimicrobial efficacy of cotton fabrics impregnated with CNF + AuNPPomegranate was evaluated according to the Hohenstein challenge test (AATCC-100) (Tong et al., 2018). Cotton fabric samples impregnated with CNF + AuNPPomegranate complex were added to 1 mL of nutrient broth containing 1.0 × 103 CFU/mL of bacteria (Jafary et al., 2015). The flasks were incubated at 37 °C for 10 h, with a rotation speed of 120 rpm. After the incubation period, viable cells were counted using the drop technique, by inoculating 10 µL of the sample diluted in nutrient agar. The antimicrobial activity of the cotton fabrics was evaluated by making a plate count of each sample at 12 h. The tests were performed in triplicate. The antimicrobial efficiency of the sample in terms of percentage of growth was determined in relation to the negative control (cotton fabrics without the complex). The percentage reduction in bacterial colonies was calculated using Equation (1):
Thirty years of conservation genetics in New Zealand: what have we learnt?
Published in Journal of the Royal Society of New Zealand, 2019
Pest control by trapping and poisoning is expensive and never-ending. Some groups, particularly the hunting lobby, object to use of pesticides such as 1080. Do new technologies offer hope that we might one day move from predator control to predator eradication? Perhaps the most exciting recent development involves the ability to manipulate chromosomal sequences using the CRISPR/Cas9 system to engineer meiotic drive elements carrying harmful (to the pest) traits, such as reduced lifespan, sterility, all-male offspring, or ability to vector disease (Champer et al. 2016; Dearden et al. 2018). Unfortunately, though, biology has a habit of fighting back through evolution (Prowse et al. 2017), as with antibiotic and herbicide resistance. Such technology will almost certainly meet with resistance from the public, but has enormous promise for eradication rather than control of pests. As we head inexorably towards ‘Predator Free 2050’, these technologies, if applied successfully, would constitute perhaps the biggest single contribution that genetics could make to conservation in New Zealand.
Windows of sensitivity to toxic chemicals in the development of reproductive effects: an analysis of ATSDR’s toxicological profile database
Published in International Journal of Environmental Health Research, 2018
Melanie C Buser, Henry G Abadin, John L Irwin, Hana R Pohl
Effects on fertility in offspring following in utero exposure was one of the most investigated endpoints in the included studies, with 25 total studies investigating 19 different chemicals (Figure 2). All of the studies resulted in decreased or impaired fertility, with some resulting in complete infertility or sterility. Nineteen of the studies were conducted in rats, and six were conducted in mice. The majority of the exposure durations of these studies does not allow for a window of sensitivity to be established; 15 of the studies exposed animals from prefertilization through full gestation and lactation, with nine of those studies continuing exposure into adulthood. Two studies utilized single-day exposures during gestation; these studies found that exposure on GD 15 to ≥ 0.01 mg/kg/day 2,3,7,8-tetrachlorodibenzodioxin (2,3,7,8-TCDD) resulted in a decreased pregnancy rate and decreased fertility in offspring (Gray and Ostby 1995; Bruner-Tran and Osteen 2011). A series of studies evaluating lactational exposure to PCBs in rats found decreased fertility in male (Sager 1983; Sager et al. 1987, 1991) and female (Sager and Girard 1994) offspring following exposure on lactational day (LD) 1 through 9 (LD1–LD9). The rest of the studies evaluating fertility focused on much longer exposure durations; thus, this information precludes the identification of a window of sensitivity. However, it does show evidence that exposure to these chemicals during any of these exposure periods – gestational only, lactational only, or gestational plus lactational – can result in adverse effects on fertility.