Control Of Particulate Matter Contamination In Healthcare Manufacturing Barber, Thomas A.||
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Written by an expert in the industry, this text addresses the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality. The author offers a clear and concise review of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. He brings together information from over 100 Web sites and other sources and casts it into a practical framework that will help readers ensure their company's success. The book contains thirty-two color photomicrographs and over eighty figures, tables, and charts.
One of the fundamental principles guiding the pharmaceutical quality of parenteral products is to prevent injecting contaminants from microbiological, chemical or physical sources. It is just as difficult to ensure the absence of chemical and particulate contaminants in injectable products as it is to weigh up the microbiological risk. The problem of particulate matter is mainly related to the preparing and administrating of injectable drugs rather than through the contamination of marketed products. Particulate contamination also arises in situ during the simultaneous intravenous (IV) infusion of incompatible drugs. A complete overview of these problems in the context of IV infusion was carried out to assess their clinical impact. Many studies had already been performed on this theme, but the majority date from the 1970s and 1980s. Clinicians have expressed a renewed interest since the early 2000s, focusing on the impact of particles on patients.
It is just as difficult to assess the risk of microbiological contamination in injectable products as it is to ensure the absence of particulate contamination in these same products . Contamination of fluids with bacteria, endotoxins and/or particles has been observed with intravenous (IV) infusion therapy. It is difficult to control particulate contamination during drug infusion, especially when several different drugs are administered simultaneously. Particulate contamination of IV fluids can result from drug incompatibilities, especially frequent in intensive care unit (ICU) patients who may receive numerous drugs simultaneously through a limited number of venous access sites. When many IV therapies have to be administered through the same central venous catheter, the risk of drug incompatibilities and thus particle formation increases.
There are several causes of particulate contamination of IV fluids. There are two types of injectable drug particulate matter according to its source : 1) intrinsic particles, defined as those initially associated with the solution which have not been eliminated either by filtration or by precipitation from the solution, and 2) extrinsic particles, defined as those that contaminate the container or solution during manufacture or preparation of drug solutions. Some of these have been described , including, for example, fibres, dust, rubber or silicone and have been known for some years, which explains the limited use of glass ampoules today in favour of plastic bottles or pods to ensure patient safety . 2b1af7f3a8