[Quantitative analysis of particulate matter in infusion solutions, administration sets and additives (author's...

There have been recevitly many comments on clinical and experimental reports which have demonstrated the safety problems associated with parenteral drugs contaminated with particles. Some countries have developed recommendations with a standard for counting of particles and their limits. Based on these limits, we have made a critical quantitative analysis of particulate matter in the most common commercially produced solutions, of particles added during manipulations in clinics and addition of drugs. Most authorities agree that particulate contamination should be kept to a minimum, above all in an intensive-care-unit where patients receive large quantities of solutions. As the risk to the patient is unacceptably high, many authors ask for filters to prevent the injection of particles in the bloodstream and their pathological consequences. A filter pore-size of 5 to 10 micron should be able to reduce this problem in a sufficient manner, without decreasing the infusion flow; whereas membrane-filters (0.22 micron), with their own problems, could also eliminate bacteria together with their microbiological hazards. Another source of particulate matter is represented by the injection of two or more drugs, administered at the same time, which may lead to chemical incompatibilities. This problem is not yet defined very well. To complete our quantitative analysis, we decided to start a prospective clinical study.