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Environmental Compliance and Control for Radiopharmaceutical Production
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Ching-Hung Chiu, Ya-Yao Huang, Wen-Yi Chang, Jacek Koziorowski
Bacterial endotoxin is the lipopolysaccharide (LPS) component of the cell wall of gram-negative bacteria. It is pyrogenic, and it is a risk to patients who are administered intravenous and intramuscular preparations [21]. The pathological effects of endotoxin, when injected, are a rapid increase in body temperature followed by extremely rapid and severe shock, often followed by death, before the cause is even diagnosed. The limulus amebocyte lysate (LAL) test is the most widely method used for endotoxin tests [22]. The pharmacopoeia monographs for the LAL test are long-established and relatively comprehensive and have been applied to the testing of parenteral products for bacterial endotoxin since the 1980s. Pyrogens are a concern for pharmaceutical drug products and for many of the ingredients used to formulate them. This is especially for radiopharmaceuticals that have direct contact with human blood. Here, by far the most concerning pyrogen is bacterial endotoxin. In relation to this, the risks of endotoxin to radiopharmaceutical processing and some of the control measures in place to reduce the risk of endotoxin contamination should be considered.
Methods of Identifying Microbiological Hazards in Indoor Environments
Published in Rafał L. Górny, Microbiological Corrosion of Buildings, 2020
In many cases, it is not possible to conduct the above-mentioned labour-intensive and time-consuming analyses, often requiring the involvement of highly qualified analysts and expensive laboratory devices. In such cases, numerous cellular components or metabolites of microorganisms may be temporarily measured to reflect real environmental exposure to harmful agents of microbial origin. So far in practice we have used several chemical markers in such cases e.g. endotoxins as markers of Gram-negative bacteria contamination, muramic acid from peptidoglycans as markers of Gram-positive bacteria contamination, ergosterol, N-acetyl-hexosaminidase and (1-3)-β-D-glucans as markers of fungal biomass. A number of instrumental and bioanalytical techniques have also been tested in practice, allowing for precise detection of the above-mentioned markers of microbiological contamination. For example, for the quantitative and qualitative evaluation of endotoxins in environmental samples, a wide range of in vitro analyses is used. They include several modifications of the Limulus amoebocyte lysate (LAL) test, recombinant factor C (rFC) assay or liquid and gas chromatography (used separately or in combination with mass spectrometry, GCMS). In turn, tests of muramic and diaminopimelic acids as markers of peptidoglycans, which are components of the bacterial cell wall structure, can be performed using GCMS.
Validation of Terminal Sterilization
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Kevin D. Trupp, Thomas J. Berger
Endotoxins are lipopolysaccharides from the outer cell membrane of gram-negative bacteria. Endotoxins can be detected by the manual gel-clot method known as the Limulus Amebocyte Lysate (LAL) test. There are also various quantitative methods (Turbidimetric and chromogenic) that use more rapid automated methodologies. All final product formulations have regulatory requirements to be tested for endotoxins and the method must be validated using three different lots of final product. LAL testing should be performed on final product formulations per FDA Guidelines and other regulatory compendia. Emulsion formulations, if colored or opaque, cannot be tested by the turbidimetric method and therefore may use a comparable test e.g., LAL, chromogenic or kinetic.
On the interpretation of bioaerosol exposure measurements and impacts on health
Published in Journal of the Air & Waste Management Association, 2019
Hamza Mbareche, Lidia Morawska, Caroline Duchaine
The Limulus amebocyte lysate (LAL) test, which uses an extract from the amebocytes of the horseshoe crab (Limulus polyphemus) and reacts with bacterial endotoxins, is probably the technique most used for endotoxin quantification. However, multiple factors, from the type of filters used for collection to the storage conditions, affect the outcome of quantification (Douwes et al. 1995; Hoppe Parr et al. 2017). Some variations to the standard LAL assay can be applied under particular conditions. For example, measurements of the turbidity of the LAL extract can be used instead of an end point chromogenic LAL assay (Neun and Dobrovolskaia 2011). Several other commercial kits have been developed for endotoxin detection. Pyrogene by Lonza ((Valais, Switzerland) and Endolisa by Hyglos (Bavaria, Germany) use the recombinant factor C (rFC) to detect the presence of LPS. HEK-Blue by InvivoGen (San Diego, CA, USA) uses the membrane receptor Toll-like receptor 4 (TLR4), which makes cellular culture necessary. PyroDetect by Merck (xx, xx) quantifies the LPS using interleukin-1β.
Assays and enumeration of bioaerosols-traditional approaches to modern practices
Published in Aerosol Science and Technology, 2020
Maria D. King, Ronald E. Lacey, Hyoungmook Pak, Andrew Fearing, Gabriela Ramos, Tatiana Baig, Brooke Smith, Alexandra Koustova
The chemical structure and toxicity of endotoxins differ across species of Gram-negative bacteria. Using endotoxin from E. coli is typically used as a reference to assess the combined activity of endotoxins with the Limulus amebocyte lysate (LAL) assay using an enzyme system from the horseshoe crab (Spaan et al. 2007). However, the LAL method is prone to interlaboratory variations and can be used only for water-soluble endotoxins (Chun et al. 2006). Monoclonal antibody-based methods have also been developed but are less sensitive than the LAL assay (Eduard et al. 2012). Endotoxins can also be estimated by gas chromatography-mass spectrometry using 3-hydroxy fatty acids as chemical markers (Spaan et al. 2008).