id author title date pages extension mime words sentences flesch summary cache txt cord-018271-ybfxtc7x van Doorne, Hans Microbiology 2015-02-09 .txt text/plain 13173 794 44 Microbial contamination of pharmaceutical preparations may cause health hazard to the patient (e.g. infection, pyrogenic or allergic reaction), altered therapeutic activity of the product, or other decrease in quality (turbidity, loss of consistency, altered pH). Microbiological quality control of pharmaceutical preparations and monitoring of production areas depend on the detection and quantification of micro-organisms. Survival and growth of micro-organisms in pharmaceutical preparations is governed by extrinsic factors (particularly temperature) and intrinsic factors (product composition and physico-chemical characteristics). Suppliers of materials may minimise the risks of contamination of TSE by ensuring [12] : • The source animals and their geographical origin • Nature of animal material used in manufacture and any procedures in place to avoid cross-contamination with higher risk materials • Production process(es) including the quality control and quality assurance system in place to ensure product consistency and traceability Manufacturers of pharmaceutical preparations select their raw materials so they are TSE free (see also Sect. However, since vaccine preparation involves the use of materials of biological origin, such as Chinese Hamster Ovary cells, vaccines are susceptible to contamination by micro-organisms, including viruses [16] [17] [18] . ./cache/cord-018271-ybfxtc7x.txt ./txt/cord-018271-ybfxtc7x.txt