ABSTRACT
Virus reduction by several steps in the manufacturing process for the intravenous immunoglobulin Vigam(®), has been investigated. The solvent/detergent step based on treatment with 0.3% tri-n-butyl phosphate and 1% polysorbate 80 at 37 °C, was confirmed to be effective for a range of enveloped viruses. Virus infectivity was undetectable i.e. >6 log inactivation within 30 min of the standard 6 h process. This was consistent over the range of conditions tested i.e. solvent/detergent and protein concentration, temperature and pH. The ion-exchange chromatography step in the process was also able to remove some viruses. Virus spiked followed by blank column runs confirmed the effectiveness of the sanitisation step for ensuring there was no virus cross contamination between column runs. The terminal low pH incubation step was also able to inactivate enveloped viruses, as well as some non-enveloped viruses. The combination of these three steps ensures a high margin of virus safety for this product.
Subject(s)
Detergents/pharmacology , Immunoglobulins, Intravenous/chemistry , Solvents/pharmacology , Virus Inactivation , Chemical Fractionation/methods , Chromatography, Ion Exchange/methods , Dose-Response Relationship, Drug , Drug Contamination/prevention & control , Humans , Hydrogen-Ion Concentration , Immunoglobulins, Intravenous/isolation & purification , Immunoglobulins, Intravenous/standards , Limit of Detection , Temperature , Viral Load/drug effects , Viruses/drug effects , Viruses/isolation & purificationABSTRACT
Biological hazards associated with the collection of solid and compostable waste have not been well characterized in North America. This is an issue because workers who handle such materials may be exposed to bioaerosols (airborne bacteria and fungi) and dusts resulting in infections or allergic diseases. We conducted a personal sampling campaign for culturable bacteria and fungi in the breathing zones of waste collectors in a variety of typical work settings (scenarios) in the province of Quebec, Canada. Total culturable bacterial and fungal counts were analyzed and compared to ambient environmental levels (background) to determine the degree of incremental exposure among workers. In several scenarios, worker exposure counts were significantly (p < or = 0.05) higher than ambient levels measured upwind, with the highest personal exposures to bacteria observed for urban compostable waste collectors (median = 50,300 Colony Forming Units/m(3) of air (CFU/m(3))). On the other hand, fungal counts collected on an every-other-week cycle were highest among a group of rural compostable waste collectors (median = 101,700 CFU/m(3)). Similar exposures to culturable bacteria and fungi have been reported in European workers who showed such adverse health effects as nausea, diarrhea, upper respiratory tract irritation, and allergy. Therefore, it may be necessary to modify certain work practices in order to minimize exposure. Recommendations include automation of waste and compost collection, use of personal protective equipment including goggles, gloves, and disposable masks, and meticulous personal hygiene.