Infusate contamination

When ultrasound was applied at moderate temperatures—below those used in pasteurization—to brain/heart infusion contaminated with Salmonella ty-phimurium, a reduction of contamination of 99% was observed [43], Once again the enhancement to the efficiency of the process induced by sonication decreased as temperature increased. Reductions in contamination were also observed in the similar treatment of skimmed milk. 

For external catheters, the source of subsequent infection is procedural contamination (poor sterile technique), subsequent catheter care and hub manipulation. Organisms invade the catheter at the exit site and migrate along the external surface of the catheter. Less common sources include hematogenous seeding (from a distant source) and infusate contamination. Infections occurring within 7-10 days of insertion are usually procedural in origin. If several of these cases... 

BiF3 is sometimes said to be infusible or to have mp at varying temperatures in the range 725-770°, but such materials are probably contaminated with the oxofluoride BiOF (p. 572). 

Meers P.D., Calder M.W., Mazhar M.M. Lawrie G.M. (1973) Intravenous infusion of contaminated dextrose solution the Devonport incident. Lancet, ii, 1189-1192. 

Denyer S.R (1982) In-use contamination in intoavenous dierq)y—die scale of die problem. In Infusions and Infection. The Hazards of In-use Contamination in Intravenous Therapy qA RF. D Arcy), pp. 1-16. Oxford Medicine Publishing Foundation. 

Advantages Simplified regimen for patient Increased patient compliance at home Decreased labor Decreased costs Decreased risk of contamination (due to less manipulation) Minimize infusion-related reactions from intravenous lipid emulsions Decreased vein irritation (especially with PPN) Improved stability compared to TNA Increased number of compatible medications Decreased bacterial growth compared to TNA Easier visual inspection Can use 0.22-micron bacterial retention filter Cost savings if unused (i.e. not spiked) intravenous lipid emulsion can be reused... 

Boruchoff SA. Hypotension and cardiac arrest in rats after infusion of mono(2-ethylhexyl)phthalate (MEHP), a contaminant of stored blood. N Engl J Med 1987 316 1218-19. 

Prophylaxis To prevent postoperative infection in contaminated or potentially contaminated colorectal surgery, the recommended adult dosage is 15 mg/kg infused over 30 to 60 minutes and completed about 1 hour before surgery followed by 7.5 mg/kg infused over 30 to 60 minutes at 6 and 12 hours after the initial dose. Complete administration of the initial preoperative dose about 1 hour before surgery so that adequate drug levels are present in the serum and tissues at the time of initial incision, and administer, if necessary, at 6-hour intervals to maintain effective drug levels. Limit prophylactic use to the day of surgery only. 

In developing countries many infections of the limbs result from exposure to punctures and subsequent contamination by organic material. In hospitals subcutaneous and intramuscular injections and intravenous (peripherally or centrally placed) infusions can be complicated respectively by subcutaneous or intramuscular abscesses and purulent (thrombo)phlebitis and secondary bacteraemia. 

At a utility compauy, a treatmeut traiu cousisting of 2 particulate bag filters and 2 MX-4 MYCELX-infused particulate bag filters were installed to treat 950,000 gal of storm water contaminated with polychlorinated biphenyls (PCBs). Treatment costs were approximately 2.8 cents/gal (D220451, p. 40). 

Cryoprecipitate may also be used for patients with factor VIII deficiency and von Willebrand disease if desmopressin is not indicated and a pathogen-inactivated, recombinant, or plasma-derived product is not available. The concentration of factor VIII and von Willebrand factor in cryoprecipitate is not as great as that found in the concentrated plasma fractions. Moreover, cryoprecipitate is not treated in any manner to decrease the risk of viral exposure. For infusion, the frozen cryoprecipitate unit is thawed and dissolved in a small volume of sterile citrate-saline solution and pooled with other units. Rh-negative women with potential for childbearing should receive only Rh-negative cryoprecipitate because of possible contamination of the product with Rh-positive blood cells. 

Studies conducted by different authors on the release of chemical substances from medical devices, mainly those used for infusing solutions, show that these are potential sources of contamination for pharmaceutical formulations. One of the most studied is diethylhexyl phthalate, the same plasticizer found in PVC infusion bags to give flexibility. The same concerns about the use of PVC bags for the storage of lipids or lipophilic formulations are valid for tubing. 

Pharmacopoeial compendia prescribe the examination of particulate contamination for injections and infusion solutions and consider particulate contamination as the presence of extraneous mobile undissolved particles, other than gas bubbles, unintentionally present in the solution. They limit the number of particles according to their size and the volume of the preparation. 

TABLE 39 Limits for Particulate Contamination in Infusion Solutions Established by ... 

The major problem associated with particulate contamination in infusion fluids is not related to the composition itself (since they are mostly pieces of the container and therefore innocuous elements) but to the potential of each particle to cause... 

Particulate contamination has been found in PN solutions and other intravenous drugs and fluids. Administration of particles through infusion solutions can result in adverse effects. The probability of these effects to occur increases proportionally with the amount of fluid administrated. 

Isomers of cyclohexanediol were found in 101 of 584 urine samples from newborn babies in a special care unit. The most abundant was ra .s -l,2-cyclohc ancdiol. No glucuronide conjugates were detected. Cyclohexanone was found as a contaminant in dextrose infusion fluids. From the five samples analysed, at an average concentration of 0.89 mg, cyclohexanone would have been delivered in 150 mL dextrose over 24 h (Mills Walker, 1990). 

Cmde enzyme extracts are often unsuitable for therapeutic uses because of their antigenicity, contamination with endotoxins, and rapid inactivation under physiological conditions or in fluids intended for intravenous infusion over several hours. When the enzyme used is a foreign protein, it can eHcit an immune response that alters the clearance rate or induces severe allergic reactions in the host. After an intravenous injection of an enzyme, its activity in plasma decreases with time due to distribution to other fluids and tissues, and as a consequence of proteolysis or excretion. Distribution is related to molecular size, charge, and HpophiHcity surface charges attributable to the availability of free amino, amido, or carboxyl groups may affect the rate of inactivation of some enzymes. 

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