Microbial contamination potential of solutions in prefilled disposable syringes used with a syringe pump

Mitrano, Francis P.; Baptista, Richard J.; Newton, David W.; Augustine, Sam C.

doi:10.1093/ajhp/43.1.78

Cited by 11 publications

(9 citation statements)

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“…The mixtures were prepared in commercial polypropylene syringes (Icogamma plus, Novico Med., Barcelona, Spain) by transferring the contents of the drug ampoules used in each mixture and adding sterilized 0.9% saline to give 60 ml in order to reflect the volume of a 5-day infusion pump. All the procedures were done under aseptic conditions in laminar flow hoods and using sterile drug solutions, even though the risk of microbial contamination of pre-filled syringes has been confirmed to be low [18,21].…”

Section: Drug Mixturesmentioning

confidence: 99%

Stability and compatibility of binary mixtures of morphine hydrochloride with hyoscine-n-butyl bromide

Barcia

Reyes

Azuara

et al. 2004

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The aim of this study was to determine the compatibility and stability of morphine hydrochloride and hyoscine-N-butyl bromide combined in solution at three different concentrations and stored in polypropylene syringes at 4 degrees C and 25 degrees C over a period of 15 days. The doses assayed were 20, 60 and 120 mg/day for morphine hydrochloride and 40, 60 and 80 mg/day for hyoscine-N-butyl bromide. These dose ranges were chosen according to daily practice. At both temperatures, all mixtures can be considered as physically compatible since no evidence of incompatibility-that is precipitation, turbidity, colour change or opacity and gas production-were observed. After 15 days of storage, the percentages of hyoscine-N-butyl bromide remaining in the drug mixtures tested ranged between 96.07% and 92.23%. At the end of the study, the percentages of morphine hydrochloride remaining in the drug mixtures were 100% at both temperatures.

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Section: Drug Mixturesmentioning

confidence: 99%

Stability and compatibility of binary mixtures of morphine hydrochloride with hyoscine-n-butyl bromide

Barcia

Reyes

Azuara

et al. 2004

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“…admixture contamination rates reported in the literature range from 0% to 14.5% (Table 1). [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Studies that tested for contamination using simulated product media fills had the lowest reported contamination rates, suggesting a lower frequency of adventitious contamination with this method. [7][8][9][10][11]18,19 Further, Trissel et al's 18,19 two independent benchmark contamination rate studies demonstrated a much higher contamination rate in the cleanroom versus the noncleanroom setting (5.2% versus <0.1%, respectively).…”

mentioning

confidence: 98%

I.V. admixture contamination rates: Traditional practice site versus a class 1000 cleanroom

Thomas

Sanborn

Couldry

2005

American Journal of Health-System Pharmacy

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“…Previous studies have confirmed that the risk of microbial contamination of prefilled syringes is low [16,17,18]. Previous studies have confirmed that the risk of microbial contamination of prefilled syringes is low [16,17,18].…”

Section: Preparation Of Solutionsmentioning

confidence: 95%

Compatibility of haloperidol and hyoscine-N-butyl bromide in mixtures for subcutaneous infusion to cancer patients in palliative care

Barcia

Reyes

Azuara

et al. 2003

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The administration of drugs by s.c. infusion is routinely practiced in palliative medicine for the management of patients who are no longer able to take oral medication. It is not uncommon for two or more drugs to be combined in s.c. infusion solutions. Unfortunately, the compatibility and stability of haloperidol and hyoscine-N-butyl bromide has not yet been determined. The objective of this study was to study the compatibility and stability of solutions containing both drugs in polypropylene syringes. Nine different solutions were assessed for up to 15 days following preparation. The solutions were prepared in polypropylene syringes with 0.9% saline as a diluent and stored at 4°C and 25°C. High-performance liquid chromatography was the analytical technique used to measure haloperidol and hyoscine-N-butyl bromide. The initial concentration ranges were 0.3125-1.25 mg/ml for haloperidol and 2.5-10.0 mg/ml for hyoscine-Nbutyl bromide. Haloperidol was pre-cipitated at a concentration of ≥1.25 mg/ml when it was combined with hyoscine-N-butyl bromide. Concentrations of hyoscine-N-butyl bromide lower than 10 mg/ml in mixtures with haloperidol or 0.625 mg/ml of haloperidol in mixtures with hyoscine-N-butyl bromide for s.c. infusion allow for the administration of both drugs without any significant loss after storage at 25°C for periods of up to 15 days, with approximately ≥90% and 88%, respectively, of haloperidol and hyoscine-N-butyl bromide remaining. However, after storage of the mixtures for equivalent periods at 4°C the losses of hyoscine-N-butyl bromide observed at the end of the study were higher than 20%, while the percentages of haloperidol remaining after 15 days at this temperature were ≥94.37%.

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Microbial contamination potential of solutions in prefilled disposable syringes used with a syringe pump

Cited by 11 publications

References 0 publications

Stability and compatibility of binary mixtures of morphine hydrochloride with hyoscine-n-butyl bromide

Stability and compatibility of binary mixtures of morphine hydrochloride with hyoscine-n-butyl bromide

I.V. admixture contamination rates: Traditional practice site versus a class 1000 cleanroom

Compatibility of haloperidol and hyoscine-N-butyl bromide in mixtures for subcutaneous infusion to cancer patients in palliative care

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