Fatal Microvascular Pulmonary Emboli From Precipitation of a Total Nutrient Admixture Solution

Hill, Steven E.; Heldman, Leslie S.; Goo, Elwin D.H.; Whippo, Paul E.; Perkinson, Joseph C.

doi:10.1177/014860719602000181

Cited by 122 publications

(82 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This iron might enter the PICVD reactor in the form of iron pentacarbonyl Fe(CO) 5 , a compound often found in trace amounts (few ppm v ) inside pressurized carbon monoxide cylinders following extended storage. 67 High resolution analysis of the C1s peak ( Indeed, this secondary compound can react with olefins through photochemical deposition when exposed to UV light.…”

Section: X-ray Photo-electron Spectroscopy (Xps)mentioning

confidence: 99%

“…2 On the other hand, major incidents of venous occlusion, organ damage, pulmonary embolism and granulomatosis in patients following injection of a parenteral drug containing foreign particulates have been reported in the past forty years. [3][4][5][6] To prevent future clinical incidents and ensure product safety, regulatory agencies require parenteral drugs to be "essentially free" of solid contaminants before reaching the consumers. 2 To meet this requirement, manufacturers make extensive use of automated particle detection systems, since it is quicker and more consistent than human inspectors, who are subjective and experience fatigue.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Gas-Phase Surface Engineering of Polystyrene Beads Used to Challenge Automated Particle Inspection Systems

Labonté

Marion

Virgilio

2016

Ind. Eng. Chem. Res.

View full text Add to dashboard Cite

Container challenge sets, used in the qualification and validation of automated visible particle inspection systems in the parenteral drug industry, are prepared by seeding a single standardized polystyrene-divinylbenzene (PS-DVB) bead inside the commercial product to mimic foreign particulates. Due to its low surface energy and wettability, the bead adheres to container walls, hindering its detection by the motion based inspection system. The aim of this research is to modify the surface properties of the bead in such a way that it repulses the inner walls and stays in suspension inside the liquid product. The surface treatment consists of a photoinduced chemical vapor deposition (PICVD) process using syngas and UVC light. Following 2 treatment, newly grafted C-OH, C-O-C, C=O and COOH functional groups on the bead's surface are observed by XPS and FTIR spectroscopy, leading to an increase in the surface energy from 31 ± 1 to 65 ± 2 mJ/m 2 , and a corresponding zeta potential decrease from -38 mV to -61 mV.Finally, treated 100 µm, 200 µm and 500 µm PS-DVB beads suspended in water exhibit higher dispersion stability over time than untreated beads. These results show the potential of syngas PICVD to provide an effective solution to the stability issue of containers challenge sets for the validation of automated particle inspection systems, enabling significant savings of time and money to the parenteral drug industry.

show abstract

Section: X-ray Photo-electron Spectroscopy (Xps)mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Gas-Phase Surface Engineering of Polystyrene Beads Used to Challenge Automated Particle Inspection Systems

Labonté

Marion

Virgilio

2016

Ind. Eng. Chem. Res.

View full text Add to dashboard Cite

show abstract

“…Tissot et al [54] detected 14.4 % of nursing errors related to drug incompatibilities in an adult ICU and Gikic et al [55] 3.4 % in a paediatric ICU. Serious consequences have been described due to drug incompatibility, such as obstruction of catheter, therapeutic failure, or the occurrence of embolism [56,57] of fatalities [58,59].…”

Section: Drug Incompatibilities: a Problem In Clinical Practicementioning

confidence: 99%

Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

Perez

Maiguy-Foinard

Barthélémy

et al. 2016

Pharmaceutical Technology in Hospital Pharmacy

View full text Add to dashboard Cite

AbstractOne of the fundamental principles guiding the pharmaceutical quality of parenteral products is to prevent injecting contaminants from microbiological, chemical or physical sources. It is just as difficult to ensure the absence of chemical and particulate contaminants in injectable products as it is to weigh up the microbiological risk. The problem of particulate matter is mainly related to the preparing and administrating of injectable drugs rather than through the contamination of marketed products. Particulate contamination also arises

show abstract

“…Visible particulate matter composed of calcium salt precipitates in drug admixtures has caused a number of serious clinical events (21). In 1994, two young female patients undergoing treatment for pelvic infections died of pulmonary emboli following intravenous administration of total nutrient admixtures containing FreAmine III as an amino acid source (14,20). Analysis of the precipitate isolated from the admixtures administered to each patient revealed the presence of calcium and phosphorous salts matching those found in the pulmonary microvasculature of the autopsy specimens.…”

Section: Size and Shapementioning

confidence: 99%

Particulate Matter in Injectable Drug Products

Langille

2013

PDA Journal of Pharmaceutical Science and Technology

View full text Add to dashboard Cite

Clinicians have had concerns about particulate matter contamination of injectable drug products since the development of the earliest intravenous therapeutics. All parenteral products contain particulate matter, and particulate matter contamination still has the potential to cause harm to patients. With tens of millions of doses of injectable drug products administered in the United States each year, it is critical to understand the types and sources of particulate matter that contaminate injectable drug products, the possible effects of injected particulate matter on patients, and the current state of regulations and standards related to particulate matter in injectable drug products. Today, the goal of manufacturers, regulators, and standards-setting organizations should be to continue to minimize the risk of particle-induced sequelae, especially in high-risk patients, without trading unnecessary manufacturing burden for minimal safety gains.

show abstract

Fatal Microvascular Pulmonary Emboli From Precipitation of a Total Nutrient Admixture Solution

Cited by 122 publications

References 16 publications

Gas-Phase Surface Engineering of Polystyrene Beads Used to Challenge Automated Particle Inspection Systems

Gas-Phase Surface Engineering of Polystyrene Beads Used to Challenge Automated Particle Inspection Systems

Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

Particulate Matter in Injectable Drug Products

Contact Info

Product

Resources

About