Particle Contamination in Contrast Media Induced by Disposable Syringes

Sendo, Toshiaki; Otsubo, Kenji; Hisazumi, Ayako; Aoyama, Toshinobu; Oishi, Ryozo

doi:10.1002/jps.2600841218

Cited by 11 publications

(6 citation statements)

References 5 publications

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“…Similar phenomena were observed in the past with silicon oil sloughing off of rubber stoppers (21,23). Differences in protein particle numbers will be difficult to assess in the presence of a large amount of counts due to silicon oil.…”

Section: Discussionsupporting

confidence: 83%

Characterization of Particles in Protein Solutions: Reaching the Limits of Current Technologies

Demeule¹,

Messick²,

Shire³

et al. 2010

AAPS J

100

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Recent publications have emphasized the lack of characterization methods available for protein particles in a size range comprised between 0.1 and 10 μm and the potential risk of immunogenicity associated with such particles. In the present paper, we have investigated the performance of light obscuration, flow microscopy, and Coulter counter instruments for particle counting and sizing in protein formulations. We focused on particles 2–10 μm in diameter and studied the effect of silicon oil droplets originating from the barrel of pre-filled syringes, as well as the effect of high protein concentrations (up to 150 mg/ml) on the accuracy of particle characterization. Silicon oil was demonstrated to contribute significantly to the particle counts observed in pre-filled syringes. Inconsistent results were observed between different protein concentrations in the range 7.5–150 mg/ml for particles <10 μm studied by optical techniques (light obscuration and flow microscopy). However, the Coulter counter measurements were consistent across the same studied concentration range but required sufficient solution conductivity from the formulation buffer or excipients. Our results show that currently available technologies, while allowing comparisons between samples of a given protein at a fixed concentration, may be unable to measure particle numbers accurately in a variety of protein formulations, e.g., at high concentration in sugar-based formulations.

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Section: Discussionsupporting

confidence: 83%

Characterization of Particles in Protein Solutions: Reaching the Limits of Current Technologies

Demeule¹,

Messick²,

Shire³

et al. 2010

AAPS J

100

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show abstract

“…Particulate matter in pharmaceutical solutions was measured with a PMS counter as described previously (19). In brief, the PMS system consisted of an APSS‐200 counter connected to a LiQuilaz‐E20 sensor with a laser diode (121 mW, 780 nm) and automatic bottle sampler, LS‐200 (Particle Measuring Systems Inc., Boulder, CO, U.S.A.).…”

Section: Methodsmentioning

confidence: 99%

Evaluation of the in-line filters for the intravenous infusion of amphotericin B fluid

et al. 1999

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“…From the adult solutions, the first 30 mL and the subsequent 100 mL were collected, and from the pediatric solutions, first and second aliquots of 50 mL were collected. Sendo et al [37] demonstrated that iodine-based contrast media interact with the silicone oil, which coats the inner surface of syringes, generating immiscible oil droplets dispersed in the formulation. Table 10.9 lists the particle counts and their size range in the first and second samples drawn from the infusion sets.…”

Section: Table 104 Elemental Analysis Of Flakes Found In a Solution mentioning

confidence: 99%

“…Vial preparation (black), after transfer (gray), united States Pharmacopeia (uSP) acceptable limit (dashed line)[37]. Vial preparation (black), after transfer (gray), united States Pharmacopeia (uSP) acceptable limit (dashed line)[37].…”

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Particulate Matter

2012

Sources of Contamination in Medicinal Products and Medical Devices

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Particle Contamination in Contrast Media Induced by Disposable Syringes

Cited by 11 publications

References 5 publications

Characterization of Particles in Protein Solutions: Reaching the Limits of Current Technologies

Characterization of Particles in Protein Solutions: Reaching the Limits of Current Technologies

Evaluation of the in-line filters for the intravenous infusion of amphotericin B fluid

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