Determining a time frame for sterility testing of intravenous admixtures

DeChant, RL; Furtado, D; Smith, F.M.; Godwin, H N; Domann, DE

doi:10.1093/ajhp/39.8.1305

Cited by 4 publications

(4 citation statements)

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“…This is in agreement with the general observations of Allwood (1 5) for the growth-supporting properties of lipid-supplemented TPN. With the exception of E. coli and the non-fat regime, organisms were recovered in significant numbers at 72 h. This is in contrast to De Chant et al (16) who showed that the recovery of viable Staphylococcus epidermidis from dextrose and saline solutions decreases significantly after 40-60 min incubation. In this study the temperature of storage rather than medium composition, osmolarity or pH, appeared to be the major determining factor with respect to survival and growth of the microorganisms.…”

Section: Discussioncontrasting

confidence: 61%

Microbial Contamination and Growth in Total Parenteral Nutrition Solutions

1988

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TPN bags (196) and giving sets were subjected to microbiological examination following administration within a busy nutrition ward. Of these, five (2.6%) were found to be contaminated with coagulase-negative Gram-positive cocci. In all but one instance the contamination was restricted to the terminal ends of the giving sets rather than to the nutrition bag itself. Isolation of micro-organisms from the ward environment suggested that the contamination had arisen extrinsically during the setting up of the infusions. Isolates from the contaminated products, together with type species of Escherichia coli and Candida albicans, were examined with respect to their growth requirements and used to challenge four TPN formulations. Growth and survival of the organisms was monitored for up to 21 days. In all instances significant numbers of organisms were recovered after 72 h. Significant growth of the Staphylococcal isolate and C. albicans occurred over the initial 48-72 h incubation, this appeared to be greater in extent for the lipid-containing formulations. The temperature of storage of the formulation was the major determining factor for microbial growth and survival. No survivors were recovered, however, from any formulation after 21 days.

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Section: Discussioncontrasting

confidence: 61%

Microbial Contamination and Growth in Total Parenteral Nutrition Solutions

1988

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“…De Chant et aE. (14) recommend a delay of less than 60 min. This means that the tests must be done immediately after production.…”

Section: Discussionmentioning

confidence: 99%

Comparative Study Between Liquid and Solid Media for the Detection of Bacterial Contamination in Intravenous Solutions

et al. 1988

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For the sterility testing of intravenous solutions, the Pharmacopeia recommend the use of liquid media. However, contamination by a single micro-organism during the test may lead to the inappropriate blocking of the release of the batch. An alternative method using solid media for culturing the membranes used in the filtration was therefore sought. With an artificial contamination with 10-100 colony-forming-units (cfu) of nine different micro-organisms, including those advocated by the Pharmacopeia, the feasibility of two different methods was assessed using two different intravenous solutions manufactured in our hospital. The results show that recoveries of minute amounts of bacteria using solid media and liquid media were similar. In all experiments there was a concordance in both positive and negative results. However, the batches of solutions have to be tested as quickly as possible after their preparation, whatever the method used, to avoid false-negative tests.

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“…Personnel were given the media-fill test later in their work shift to mimic more stressful scenario, as suggested by Chapter <797> and the literature. 12,22 Media bags were incubated at room temperature for 14 days, then visually evaluated. Successful technique was indicated by a clear solution.…”

Section: Personnelmentioning

confidence: 99%

Sterile Preparation Evolves: A USP <797> Implementation Story

Stein

2006

Hosp Pharm

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The United States Pharmacopeia (USP) revised and renumbered the chapter describing sterile product preparation. Renumbering the document resulted in enforceable requirements for sterile preparation. This document, the infamous Chapter <797>, will improve sterile preparation in many institutions. The regulation change was a result of contaminated preparations following attempts to standardize sterile guidelines. The process to understand, review, plan, and implement change and improvement in sterile preparation process is an initially vast, but ongoing task. The journey of USP <797> implementation at Oregon Health & Science University (OHSU) involved education, gap analysis, reorganization, and training. Sections of Chapter <797> posed particular challenges and issues in areas including environmental and equipment, product preparation, storage, and dating, as well as, personnel training and testing. Financial implications of fully implementing the recommendations can be overwhelming. Regardless, institutions must start the process by working in their current environment, while maintaining focus on a vision of a fully compliant sterile product preparation system.

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Determining a time frame for sterility testing of intravenous admixtures

Cited by 4 publications

References 0 publications

Microbial Contamination and Growth in Total Parenteral Nutrition Solutions

Microbial Contamination and Growth in Total Parenteral Nutrition Solutions

Comparative Study Between Liquid and Solid Media for the Detection of Bacterial Contamination in Intravenous Solutions

Sterile Preparation Evolves: A USP <797> Implementation Story

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