Microbial Contamination of Non-Sterile Pharmaceutical Products Made in Hospitals in the North East Thames Regional Health Authority

Abstract

Non‐sterile pharmaceutical products made in nine hospitals in the North East Thames Regional Health Authority were examined for microbial contamination as part of a quality assurance programme. The incidence of contamination was found to vary between hospitals, but in all cases improvements were seen during the 3‐year monitoring period in the microbiological quality of products made in individual hospitals. The most common isolates were aerobic spore bearers—usually less than 102 colony forming units/g or ml. Gram‐negative isolates were found in at least one product from each hospital. Pseudomonas spp. were isolated from several samples of peppermint water.

Revolutionizing the Major Threat Challenges in Pharmaceutical Industries by Monitoring Heating, Ventilation and Air Conditioning Systems

“…Manufacturing of pharmaceutical drug substances in this atmosphere condition is well identified to produce adverse effects and lethal influence on both the animals as well as human beings which endures through no distinct perception and remains basically unregulated. Major microbial contamination was observed for non-sterile products because of raw material or water may contain of microorganism (Baird 1985).…”

“…Routine air sampling monitoring includes both viable and nonviable airborne particulates in the location. In non-sterile and sterile manufacturing area major source of microbial contamination is by viable particulates, whereas laboratory persons can be the source of both particulates (Baird 1985;Mestrandrea 1997;Akers and Agallaco 2001;Reich et al 2003).…”