The microbial content of non-sterile pharmaceuticals distributed in Norway.
Seventy-seven registered trademark pharmaceuticals and allied products, not required by the relevant monographs to comply with the test for sterility, were investigated for their microbial content. All the products examined complied with current regulations with respect to the numbers and types of microbes isolated, indicating the effectiveness of existing production practices in meeting existing standards. Gram-positive endospore-forming rods accounted for the majority of the bacteria isolated. Gram-negative rods were present for the most part in incidental numbers. However, some of these were of species that have been previously indicated as opportunistic pathogens and which should be considered as objectionable in pharmaceuticals. A number of the isolates showed antibiotic resistances unusual for the species in question.
Charnock
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Faculty of Health Sciences, Oslo University College, 0167 Oslo, Norway. colin.charnock@hf.hio.no
D000284:Administration, Oral; D000287:Administration, Topical; D001431:Bacteriological Techniques; D015169:Colony Count, Microbial; D004340:Drug Contamination / Q000706:statistics & numerical data*; D004335:Drug and Narcotic Control / Q000458:organization & administration; D004725:Endospore-Forming Bacteria / Q000145:classification / Q000302:isolation & purification*; D004783:Environmental Microbiology / Q000592:standards*; D016946:Gram-Negative Aerobic Rods and Cocci / Q000145:classification / Q000302:isolation & purification*; D006095:Gram-Positive Cocci / Q000145:classification / Q000302:isolation & purification*; D017408:Guidelines as Topic; D006801:Humans; D008826:Microbial Sensitivity Tests; D015999:Multivariate Analysis; D009664:Norway; D010330:Patents as Topic; D010802:Phylogeny; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D012042:Registries; D013242:Sterilization