Viability-based rapid microbiological methods for sterility testing and the need for identification of contamination.
Moldenhauer
Jeanne
J
Vectech Pharmaceutical Consultants, Inc., Farmington Hills, MI, USA.
D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D017408:Guidelines as Topic; D007218:Industrial Microbiology / Q000379:methods*; D050296:Microbial Viability; D008828:Microbiological Techniques; D015203:Reproducibility of Results; D012107:Research Design; D012308:Risk Management; D018401:Sample Size; D013194:Staining and Labeling; D013242:Sterilization / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards