Standard aeration for gas-sterilized plastics

White, J. D.

doi:10.1017/s0022172400053031

Cited by 9 publications

(5 citation statements)

References 16 publications

(12 reference statements)

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“…Approximate first-order rates of EO release from sterilized EO absorbent medical product materials are consistent with the corresponding approximate 2 h typical half-time of EO release (approximate range: 1–6 h) [21,22,24,25]. Similar rates of first-order EO loss from product sterilization of packaging materials (EO permeable plastic enclosures, cardboard boxes and separators, spice bags, etc.)…”

Section: Methodssupporting

confidence: 69%

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Reevaluation of Historical Exposures to Ethylene Oxide Among U.S. Sterilization Workers in the National Institute of Occupational Safety and Health (NIOSH) Study Cohort

Bogen

Sheehan

Valdez‐Flores

et al. 2019

IJERPH

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The 2016 U.S. Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) assessment for ethylene oxide (EO) estimated a 10−6 increased inhalation cancer risk of 0.1 parts per trillion, based on National Institute of Occupational Safety and Health (NIOSH) epidemiology studies of sterilization facility workers exposed to EO between 1938 and 1986. The worker exposure estimates were based on a NIOSH statistical regression (NSR) model “validated” with EO levels measured after 1978. Between 1938 and 1978, when EO data was unavailable, the NSR model predicts exposures lowest in 1938 increasing to peak levels in 1978. That increasing EO concentration trend arose, in part, because engineering/industrial-hygiene (E/IH) factors associated with evolving EO-sterilization equipment and operations before 1978 were not properly considered in the NSR model. To test the NSR model trend prediction, a new E/IH-based model was developed using historical data on EO kill concentrations, EO residue levels in sterilized materials, post-wash EO concentrations in a sterilization chamber, and information on facility characteristics and sterilizer operator practices from operators familiar with pre-1978 industry conditions. The E/IH 90th percentile of 8 h time-weighted average EO exposures (C90) for highly exposed sterilizer operators was calibrated to match 1978 C90 values from the NSR model. E/IH model C90 exposures were estimated to decrease over time from levels 16 and were four-fold greater than NSR-estimated exposures for workers during 1938–1954 and 1955–1964. This E/IH modeled trend is opposite to that of NSR model predictions of exposures before 1978, suggesting that EPA’s exclusive reliance on the NIOSH cohort to estimate EO cancer risk should be re-examined.

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Section: Methodssupporting

confidence: 69%

“…d Extrapolated from Late/Medical/health scenario assumptions (see Methods). e Estimated from Bruch [21,22]; Stetson et al [24]; and White [25].…”

Section: Figurementioning

confidence: 99%

Reevaluation of Historical Exposures to Ethylene Oxide Among U.S. Sterilization Workers in the National Institute of Occupational Safety and Health (NIOSH) Study Cohort

Bogen

Sheehan

Valdez‐Flores

et al. 2019

IJERPH

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“…were sterilized using gamma irradiation. Other sterilization methods were tested and abandoned because ethanol and ethylene oxide readily partition into plastic components(20), and autoclaving is not suitable for the assemblies containing materials with drastically different coefficients of thermal expansion. The 2 partially assembled reactor portions (illustrated in Supplemental Figure S1) allowed for ease in loading the 3D matrix and cell components and the subsequent easy alignment and combination of the two portions into a complete system.…”

Section: Methodsmentioning

confidence: 99%

Thick-tissue bioreactor as a platform for long-term organotypic culture and drug delivery

Markov

Samson

et al. 2012

Lab Chip

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We have developed a novel, portable, gravity-fed, microfluidics-based platform suitable for optical interrogation of long-term organotypic cell culture. This system is designed to provide convenient control of cell maintenance, nutrients, and experimental reagent delivery to tissue-like cell densities housed in a transparent, low-volume microenvironment. To demonstrate the ability of our Thick-Tissue Bioreactor (TTB) to provide stable, long-term maintenance of high-density cellular arrays, we observed the morphogenic growth of human mammary epithelial cell lines, MCF-10A and their invasive variants, cultured under three-dimensional (3D) conditions inside our system. Over the course of 21 days, these cells typically develop into hollow “mammospheres” if cultured in standard 3D Matrigel. This complex morphogenic process requires alterations in a variety of cellular functions, including degradation of extracellular matrix that is regulated by cell-produced matrix proteinases. For our “drug” delivery testing and validation experiments we have introduced proteinase inhibitors into the fluid supply system, and we observed both reduced proteinase activity and inhibited cellular morphogenesis. The size inhibition results correlated well with the overall proteinase activities of the tested cells.

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“…Plot displays time required for residual ethylene oxide to aerate passively below 50 ppm from various medical plastics (LDPE = Low density polyethylene, PP = Polypropylene, PTFE = Polytetrafluoroethylene, PET = Polyethylene terephthalate). Reproduced with permission from ref . Copyright 1977 Cambridge University Press.…”

Section: Sterilization Techniquesmentioning

confidence: 99%

Wireless Battery-free and Fully Implantable Organ Interfaces

Bhatia,

Hanna,

Stuart

et al. 2024

Chem. Rev.

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Advances in soft materials, miniaturized electronics, sensors, stimulators, radios, and battery-free power supplies are resulting in a new generation of fully implantable organ interfaces that leverage volumetric reduction and soft mechanics by eliminating electrochemical power storage. This device class offers the ability to provide high-fidelity readouts of physiological processes, enables stimulation, and allows control over organs to realize new therapeutic and diagnostic paradigms. Driven by seamless integration with connected infrastructure, these devices enable personalized digital medicine. Key to advances are carefully designed material, electrophysical, electrochemical, and electromagnetic systems that form implantables with mechanical properties closely matched to the target organ to deliver functionality that supports high-fidelity sensors and stimulators. The elimination of electrochemical power supplies enables control over device operation, anywhere from acute, to lifetimes matching the target subject with physical dimensions that supports imperceptible operation. This review provides a comprehensive overview of the basic building blocks of battery-free organ interfaces and related topics such as implantation, delivery, sterilization, and user acceptance. State of the art examples categorized by organ system and an outlook of interconnection and advanced strategies for computation leveraging the consistent power influx to elevate functionality of this device class over current battery-powered strategies is highlighted.

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Standard aeration for gas-sterilized plastics

Cited by 9 publications

References 16 publications

Reevaluation of Historical Exposures to Ethylene Oxide Among U.S. Sterilization Workers in the National Institute of Occupational Safety and Health (NIOSH) Study Cohort

Reevaluation of Historical Exposures to Ethylene Oxide Among U.S. Sterilization Workers in the National Institute of Occupational Safety and Health (NIOSH) Study Cohort

Thick-tissue bioreactor as a platform for long-term organotypic culture and drug delivery

Wireless Battery-free and Fully Implantable Organ Interfaces

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