Contaminated medicaments in use in a hospital for diseases of the skin

Baird, R M; Awad, Zaid; Shooter, R. A.; Noble, W. C.

doi:10.1017/s0022172400026589

Cited by 14 publications

(7 citation statements)

References 11 publications

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“…Liquid antacids are occasionally heavily contaminated with microorganisms (1,5,(8)(9)(10); members of the genus Bacillus are frequently found in association with this contamination. This report is concerned with the use of a recently described computer-assisted probability method (13) for the identification of a wide range of Bacillus species isolated from pharmaceutical liquid antacids and their constituent chemical compounds.…”

mentioning

confidence: 99%

Computer-assisted method for identification of Bacillus species isolated from liquid antacids

Willemse-Collinet¹,

Turnbull²,

Hospers³

et al. 1981

Appl Environ Microbiol

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One hundred nineteen species of Bacillus were isolated from five heavily contaminated liquid antacids and their constituent chemicals. The 66 different reaction profiles obtained were expressed in probability figures and stored in a computer. A total of 13 Bacillus species were identified, with B. coagulans, B. licheniformis, B. subtilis, and B. polymyxa present at particularly high frequencies. The potential advantage of using a computer in the identification of aerobic sporeformers is demonstrated.

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mentioning

confidence: 99%

Computer-assisted method for identification of Bacillus species isolated from liquid antacids

Willemse-Collinet¹,

Turnbull²,

Hospers³

et al. 1981

Appl Environ Microbiol

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“…Despite these improvements, outbreaks of infection continue to be reported from time to time. [8][9][10][11][12] Microbial contamination has been one of the prime reasons for regulatory product recalls for the recent years with the most frequently detected Gram-negative organisms. 5 Hence, strict microbiological quality control (QC) is required to ensure delivery of safe products to the customers and the surface sampling of the clean rooms is an integral part of environmental monitoring (EM) program.…”

Section: Resultsmentioning

confidence: 99%

Control Chart in Microbiological Cleaning Efficacy of Pharmaceutical Facility

Eissa¹,

Mahmoud²,

Nouby

2016

Dhaka Univ. J. Pharm. Sci

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Statistical process control and quality control charts have important applications in the field of microbiological quality control of clean area. Monitoring the environment and the surface samples using contact plates is critical to verify microbiological cleaning efficacy of the surface and to understand the behavior of the operation. In the current study, RODAC (Replicate Organism Detection and Counting) plates were used to sample surfaces in production rooms for semisolid and liquid products in a course of two years and overall performance was assessed using I-MR chart and data were subjected to analysis. The throughput yield (TPY) was 0.999993 and the overall process capability was acceptable (Ppk was 1.45). The used methodology in microbiological quality control is simple, fast and not expensive, which provides insight for the evaluation of the process efficiency and highlights the limiting factors and the drawbacks that affect the performance.Dhaka Univ. J. Pharm. Sci. 14(2): 133-138, 2015 (December)

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“…The existence of microbial contaminants was not only found to generate physicochemical changes that led to the spoilage of multiple products [1][2][3] , but was also proved to be a possible health threat to the consumer [4][5][6] as documented by numerous incidents of drug-related infections 1,[7][8][9] .…”

Section: Introductionmentioning

confidence: 99%

Untitled

2020

IJPSR

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Notable progress has been made in methods that encourage the use of PCR as a rapid and accurate tool in quality evaluation of pharmaceuticals. In this study, monoplex and multiplex PCR based assays were developed and compared with standard conventional methods for rapid detection of three specified topical indicator pathogens, Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans, in nonsterile pharmaceutical preparations. The detection limit of monoplex PCR assays for the microbial targets was achieved at 100 fg purified DNA and 10 CFU/ml for Pseudomonas aeruginosa and 1fg purified DNA and 10 CFU/ml for each of Staphylococcus aureus and Candida albicans. No change in the detection limit for cfu/ml of the three tested indicator pathogens was obtained upon using mPCR assays. The results of applying both conventional and PCR detection methods for different cream and lotion preparations revealed a 100% correlation between both methods. The PCR based detection method can be completed in 8 h versus 5-6 days in case of conventional methods, but the former can't differentiate between viable and dead cells. PCR assays can be used efficiently and in a cost-effective manner to exclude the contamination of pharmaceutical products by the indicator pathogens. Even though in case of contamination by non-viable indicator organism, PCR technique can still be used after partial incubation of cultivated test sample. Thus, PCR assays provide specific, reliable results that can be incorporated in quality evaluation of pharmaceuticals and will impact positively in terms of cost and time.

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Contaminated medicaments in use in a hospital for diseases of the skin

Cited by 14 publications

References 11 publications

Computer-assisted method for identification of Bacillus species isolated from liquid antacids

Computer-assisted method for identification of Bacillus species isolated from liquid antacids

Control Chart in Microbiological Cleaning Efficacy of Pharmaceutical Facility

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