Particulate contamination of lyophilized amphotericin B preparation during reconstitution process

Sendo, Toshiaki; Hirakawa, Masaaki; Makino, Kazutaka; Nakashima, Kentaro; Kataoka, Yasufumi; Oishi, Ryozo

doi:10.1046/j.1365-2710.2001.00328.x

Cited by 7 publications

(2 citation statements)

References 15 publications

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“…and after contact with the powdered samples. Sendo et al [17] observed not only haze but also particulate formation after lyophilized amphotericin B reconstitution with water for injection (WFI), which was probably caused by the same phenomenon observed by Jaehnke et al [16]. The data, presented in Table 7.19, allow the conclusion that after dissolution of the powdered sample in water, the volatiles remain insoluble and form an emulsion that appears as a haze.…”

supporting

confidence: 55%

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2012

Sources of Contamination in Medicinal Products and Medical Devices

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supporting

confidence: 55%

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2012

Sources of Contamination in Medicinal Products and Medical Devices

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“…The possibility of other contaminants and debris, such as rubbers, plastic utensils, and needle shards, could not be completely denied from past reports. [23][24][25]…”

Section: Verification Of Insoluble Fine Particles Using Sem Ftir and Sem-eds Analysismentioning

confidence: 99%

Frequency and component analysis of contaminants generated in preparation of anticancer agents using Closed system drug transfer devices (CSTDs)

Sumikawa

Yakushijin

Aogi

et al. 2021

Preprint

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Occupational exposure of anticancer agents during their preparation has been recognized as a serious hazard. Closed system drug transfer devices (CSTDs) enable “safe” preparation of agents for medical personnel and ensure a safe hospital environment. However, artificial particles of infusion materials have been reported during CSTD use. Here, the incidence of insoluble fine particles during preparation of anticancer agents using CSTDs was examined. Visible insoluble fine particles were found in 465 (9.4%) of 4,948 treatment cases at Ehime University Hospital with CSTD use. Contaminants occurred more frequently during preparation of monoclonal antibodies than cytotoxic anticancer agents (19.4% versus 4.1%, respectively, P<0.01). A similar survey was conducted at nine hospitals to investigate the incidence of insoluble fine particles with or without CSTDs. Insoluble fine particles were detected in 113 (15.4%) of 732 treatment cases during preparation of monoclonal antibodies with CSTD use. In contrast, the occurrence of insoluble fine particles without CSTDs was found in only 3 (0.073%) of 4,113 treatment cases. Contamination with CSTDs might cause harmful effects on patients 4 during cancer therapy. We strongly recommend the use of in-line filters combined with infusion routes after CSTD use to avoid contamination-associated adverse events.

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Particles Shed from Syringe Filters and Their Effects on Agitation-Induced Protein Aggregation

Liu

Randolph

Carpenter

2012

Journal of Pharmaceutical Sciences

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Particulate contamination of lyophilized amphotericin B preparation during reconstitution process

Abstract: These findings suggest that reconstituted solutions should be filtered with membrane filters and diluted fluids with in-line filters.

Cited by 7 publications

References 15 publications

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Frequency and component analysis of contaminants generated in preparation of anticancer agents using Closed system drug transfer devices (CSTDs)

Particles Shed from Syringe Filters and Their Effects on Agitation-Induced Protein Aggregation

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